Marlene Busko

ObesityWeek 2022 is the largest international conference on obesity, with over 100 sessions, and coincides with the 40th anniversary of the Obesity Society. Being held Nov. 1-4, it is a hybrid meeting that participants can attend onsite in sunny San Diego or virtually.
 

“The meeting offers a wide perspective, from basic science, all the way to public policy on studies of treatment and prevention of obesity,” program planning chair for ObesityWeek, Kelly C. Allison, PhD, said in an interview.

Rodrigo Cuel/Thinkstock

The Presidential Plenary session on Nov. 1 will kick off the meeting with “a series of 10-minute rapid talks on cutting-edge topics in the field,” noted Dr. Allison, who is also director, Center for Weight and Eating Disorders, Hospital of the University of Pennsylvania, and professor of psychiatry, University of Pennsylvania, both in Philadelphia.

Among others, Ania M. Jastreboff, MD, PhD, will speak about “New developments in anti-obesity pharmacotherapy,” and Theodore K. Kyle, RPh, MBA, will discuss “Reducing barriers to treatment: Insurance coverage.”

“We’re seeing some pretty effective antiobesity medication, but still they are not being covered by many insurances,” said Dr. Allison. Some clinicians might be hesitant to prescribe antiobesity medications, remembering older drugs that were pulled from the market for health concerns, and some patients may also have concerns, she speculated. There is a need for greater education about the current antiobesity drugs.

In his presidential address, Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, will discuss “Regulation of body weight and adaptive responses to weight loss.”

Pediatric obesity is a major focus of this year›s conference too, Allison noted.

At 8 a.m on Nov. 3, The Obesity Society, the World Obesity Federation, the European Association for the Study of Obesity, and Obesity Canada will present a joint symposium, “International innovations in pediatric obesity,” with speakers from Canada, Australia, and Ireland discussing ongoing paradigm shifts in the prevention and treatment of pediatric obesity.

Two hours later, at a joint symposium by the American Academy of Pediatrics/The Obesity Society, attendees will get a behind-the-scenes look at the making of the new AAP Obesity Clinical Practice Guideline for children and adolescents with obesity.

The conference tracks reflect the broad scope of this event: Track 1: Metabolism and Integrative Physiology; Track 2: Neuroscience; Track 3: Interventional and Clinical Studies; Track 4: Population Health; Track 5: Clinical/Professional Practice; Track 6: Policy/Public Health, and a subtrack: Eradicating Treatment Barriers.

Dr. Allison highlighted the following oral presentations and posters about antiobesity drugs:

• “Once-weekly subcutaneous semaglutide 2.4 mg in adolescents with overweight or obesity,” with an extended Q&A session, Nov. 2.
• “Clinical outcomes with medication use in tertiary pediatric weight management program,” by Enayet and colleagues. Poster 030.
• “The metabolically healthy obese paradigm and liver fat content in the Fels longitudinal study,” by Garza and colleagues Oral 055, Nov. 2.
• “Phase 3 clinical trial of metformin for treatment of COVID-19 in adults with overweight and obesity,” by Bramante and colleagues. Oral 067, Nov. 3. This trial was published in the  (N Engl J Med. 2022;387:599-610). 
• “Glucagon/GLP-1 receptor dual agonist BI 456906 reduces bodyweight in patients with type 2 diabetes,” by Rosenstock and colleagues. Oral-063, Nov. 3. 
• “A randomized controlled trial of naltrexone and bupropion and behavior therapy for binge-eating disorder,” by Grilo and colleagues. Oral 066, Nov. 3.

And on Nov. 4, researchers will present four oral abstracts about the dual glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1) receptor agonist tirzepatide (Mounjaro), which is approved for type 2 diabetes and now has fast track designation for weight loss from the Food and Drug Administration. Oral abstracts 109, 110, 111, and 112 cover weight loss with tirzepatide across different age groups, body mass indexes, and comorbidities, as well as quality of life.

Dr. Allison also highlighted the following presentations that cover other diverse topics:

• Family-based treatment: “Pilot study to inform a randomized controlled trial of HeLP: Obesity prevention & treatment for the entire Hispanic family,” by Haemer and colleagues. Oral 029. November 2.
• Bariatric surgery: “Long-term outcomes of laparoscopic sleeve gastrectomy from 2010-2016: A nationwide cohort study,” Oral 014. Nov. 2.
• Prevention/public health: “Impact of positive and negative front-of-package food labels in a randomized experiment,” by Grummon and colleagues. Oral 068. Nov. 3.
• Time-restricted eating: “Effects of 8-hour time restricted eating for weight loss over 12 months,” by Gabel and colleagues. Oral 102. Nov. 4.
• Patient management: “Identifying interprofessional drivers of practice gaps in the management of patients with obesity,” by Robinson and colleagues. Poster 055.

On Nov. 4, researchers will present five winning papers that will be published in the December issue of the Obesity journal about GLP-1 agonists versus bariatric surgery; monoacylglycerol O-acyltransferase 1 in mice; a behavioral weight-loss intervention; the Canberra Obesity Management Service; and macronutrient (im)balance in an obesogenic environment.

“I’m always excited to hear some talks that are outside of my comfort area to understand the mechanisms of obesity better,” concluded Dr. Allison.

A version of this article first appeared on Medscape.com.

ObesityWeek 2022 is the largest international conference on obesity, with over 100 sessions, and coincides with the 40th anniversary of the Obesity Society. Being held Nov. 1-4, it is a hybrid meeting that participants can attend onsite in sunny San Diego or virtually.
 

“The meeting offers a wide perspective, from basic science, all the way to public policy on studies of treatment and prevention of obesity,” program planning chair for ObesityWeek, Kelly C. Allison, PhD, said in an interview.

Rodrigo Cuel/Thinkstock

The Presidential Plenary session on Nov. 1 will kick off the meeting with “a series of 10-minute rapid talks on cutting-edge topics in the field,” noted Dr. Allison, who is also director, Center for Weight and Eating Disorders, Hospital of the University of Pennsylvania, and professor of psychiatry, University of Pennsylvania, both in Philadelphia.

Among others, Ania M. Jastreboff, MD, PhD, will speak about “New developments in anti-obesity pharmacotherapy,” and Theodore K. Kyle, RPh, MBA, will discuss “Reducing barriers to treatment: Insurance coverage.”

“We’re seeing some pretty effective antiobesity medication, but still they are not being covered by many insurances,” said Dr. Allison. Some clinicians might be hesitant to prescribe antiobesity medications, remembering older drugs that were pulled from the market for health concerns, and some patients may also have concerns, she speculated. There is a need for greater education about the current antiobesity drugs.

In his presidential address, Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, will discuss “Regulation of body weight and adaptive responses to weight loss.”

Pediatric obesity is a major focus of this year›s conference too, Allison noted.

At 8 a.m on Nov. 3, The Obesity Society, the World Obesity Federation, the European Association for the Study of Obesity, and Obesity Canada will present a joint symposium, “International innovations in pediatric obesity,” with speakers from Canada, Australia, and Ireland discussing ongoing paradigm shifts in the prevention and treatment of pediatric obesity.

Two hours later, at a joint symposium by the American Academy of Pediatrics/The Obesity Society, attendees will get a behind-the-scenes look at the making of the new AAP Obesity Clinical Practice Guideline for children and adolescents with obesity.

The conference tracks reflect the broad scope of this event: Track 1: Metabolism and Integrative Physiology; Track 2: Neuroscience; Track 3: Interventional and Clinical Studies; Track 4: Population Health; Track 5: Clinical/Professional Practice; Track 6: Policy/Public Health, and a subtrack: Eradicating Treatment Barriers.

Dr. Allison highlighted the following oral presentations and posters about antiobesity drugs:

• “Once-weekly subcutaneous semaglutide 2.4 mg in adolescents with overweight or obesity,” with an extended Q&A session, Nov. 2.
• “Clinical outcomes with medication use in tertiary pediatric weight management program,” by Enayet and colleagues. Poster 030.
• “The metabolically healthy obese paradigm and liver fat content in the Fels longitudinal study,” by Garza and colleagues Oral 055, Nov. 2.
• “Phase 3 clinical trial of metformin for treatment of COVID-19 in adults with overweight and obesity,” by Bramante and colleagues. Oral 067, Nov. 3. This trial was published in the  (N Engl J Med. 2022;387:599-610). 
• “Glucagon/GLP-1 receptor dual agonist BI 456906 reduces bodyweight in patients with type 2 diabetes,” by Rosenstock and colleagues. Oral-063, Nov. 3. 
• “A randomized controlled trial of naltrexone and bupropion and behavior therapy for binge-eating disorder,” by Grilo and colleagues. Oral 066, Nov. 3.

And on Nov. 4, researchers will present four oral abstracts about the dual glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1) receptor agonist tirzepatide (Mounjaro), which is approved for type 2 diabetes and now has fast track designation for weight loss from the Food and Drug Administration. Oral abstracts 109, 110, 111, and 112 cover weight loss with tirzepatide across different age groups, body mass indexes, and comorbidities, as well as quality of life.

Dr. Allison also highlighted the following presentations that cover other diverse topics:

• Family-based treatment: “Pilot study to inform a randomized controlled trial of HeLP: Obesity prevention & treatment for the entire Hispanic family,” by Haemer and colleagues. Oral 029. November 2.
• Bariatric surgery: “Long-term outcomes of laparoscopic sleeve gastrectomy from 2010-2016: A nationwide cohort study,” Oral 014. Nov. 2.
• Prevention/public health: “Impact of positive and negative front-of-package food labels in a randomized experiment,” by Grummon and colleagues. Oral 068. Nov. 3.
• Time-restricted eating: “Effects of 8-hour time restricted eating for weight loss over 12 months,” by Gabel and colleagues. Oral 102. Nov. 4.
• Patient management: “Identifying interprofessional drivers of practice gaps in the management of patients with obesity,” by Robinson and colleagues. Poster 055.

On Nov. 4, researchers will present five winning papers that will be published in the December issue of the Obesity journal about GLP-1 agonists versus bariatric surgery; monoacylglycerol O-acyltransferase 1 in mice; a behavioral weight-loss intervention; the Canberra Obesity Management Service; and macronutrient (im)balance in an obesogenic environment.

“I’m always excited to hear some talks that are outside of my comfort area to understand the mechanisms of obesity better,” concluded Dr. Allison.

A version of this article first appeared on Medscape.com.

ObesityWeek 2022 is the largest international conference on obesity, with over 100 sessions, and coincides with the 40th anniversary of the Obesity Society. Being held Nov. 1-4, it is a hybrid meeting that participants can attend onsite in sunny San Diego or virtually.
 

“The meeting offers a wide perspective, from basic science, all the way to public policy on studies of treatment and prevention of obesity,” program planning chair for ObesityWeek, Kelly C. Allison, PhD, said in an interview.

Rodrigo Cuel/Thinkstock

The Presidential Plenary session on Nov. 1 will kick off the meeting with “a series of 10-minute rapid talks on cutting-edge topics in the field,” noted Dr. Allison, who is also director, Center for Weight and Eating Disorders, Hospital of the University of Pennsylvania, and professor of psychiatry, University of Pennsylvania, both in Philadelphia.

Among others, Ania M. Jastreboff, MD, PhD, will speak about “New developments in anti-obesity pharmacotherapy,” and Theodore K. Kyle, RPh, MBA, will discuss “Reducing barriers to treatment: Insurance coverage.”

“We’re seeing some pretty effective antiobesity medication, but still they are not being covered by many insurances,” said Dr. Allison. Some clinicians might be hesitant to prescribe antiobesity medications, remembering older drugs that were pulled from the market for health concerns, and some patients may also have concerns, she speculated. There is a need for greater education about the current antiobesity drugs.

In his presidential address, Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, will discuss “Regulation of body weight and adaptive responses to weight loss.”

Pediatric obesity is a major focus of this year›s conference too, Allison noted.

At 8 a.m on Nov. 3, The Obesity Society, the World Obesity Federation, the European Association for the Study of Obesity, and Obesity Canada will present a joint symposium, “International innovations in pediatric obesity,” with speakers from Canada, Australia, and Ireland discussing ongoing paradigm shifts in the prevention and treatment of pediatric obesity.

Two hours later, at a joint symposium by the American Academy of Pediatrics/The Obesity Society, attendees will get a behind-the-scenes look at the making of the new AAP Obesity Clinical Practice Guideline for children and adolescents with obesity.

The conference tracks reflect the broad scope of this event: Track 1: Metabolism and Integrative Physiology; Track 2: Neuroscience; Track 3: Interventional and Clinical Studies; Track 4: Population Health; Track 5: Clinical/Professional Practice; Track 6: Policy/Public Health, and a subtrack: Eradicating Treatment Barriers.

Dr. Allison highlighted the following oral presentations and posters about antiobesity drugs:

• “Once-weekly subcutaneous semaglutide 2.4 mg in adolescents with overweight or obesity,” with an extended Q&A session, Nov. 2.
• “Clinical outcomes with medication use in tertiary pediatric weight management program,” by Enayet and colleagues. Poster 030.
• “The metabolically healthy obese paradigm and liver fat content in the Fels longitudinal study,” by Garza and colleagues Oral 055, Nov. 2.
• “Phase 3 clinical trial of metformin for treatment of COVID-19 in adults with overweight and obesity,” by Bramante and colleagues. Oral 067, Nov. 3. This trial was published in the  (N Engl J Med. 2022;387:599-610). 
• “Glucagon/GLP-1 receptor dual agonist BI 456906 reduces bodyweight in patients with type 2 diabetes,” by Rosenstock and colleagues. Oral-063, Nov. 3. 
• “A randomized controlled trial of naltrexone and bupropion and behavior therapy for binge-eating disorder,” by Grilo and colleagues. Oral 066, Nov. 3.

And on Nov. 4, researchers will present four oral abstracts about the dual glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1) receptor agonist tirzepatide (Mounjaro), which is approved for type 2 diabetes and now has fast track designation for weight loss from the Food and Drug Administration. Oral abstracts 109, 110, 111, and 112 cover weight loss with tirzepatide across different age groups, body mass indexes, and comorbidities, as well as quality of life.

Dr. Allison also highlighted the following presentations that cover other diverse topics:

• Family-based treatment: “Pilot study to inform a randomized controlled trial of HeLP: Obesity prevention & treatment for the entire Hispanic family,” by Haemer and colleagues. Oral 029. November 2.
• Bariatric surgery: “Long-term outcomes of laparoscopic sleeve gastrectomy from 2010-2016: A nationwide cohort study,” Oral 014. Nov. 2.
• Prevention/public health: “Impact of positive and negative front-of-package food labels in a randomized experiment,” by Grummon and colleagues. Oral 068. Nov. 3.
• Time-restricted eating: “Effects of 8-hour time restricted eating for weight loss over 12 months,” by Gabel and colleagues. Oral 102. Nov. 4.
• Patient management: “Identifying interprofessional drivers of practice gaps in the management of patients with obesity,” by Robinson and colleagues. Poster 055.

On Nov. 4, researchers will present five winning papers that will be published in the December issue of the Obesity journal about GLP-1 agonists versus bariatric surgery; monoacylglycerol O-acyltransferase 1 in mice; a behavioral weight-loss intervention; the Canberra Obesity Management Service; and macronutrient (im)balance in an obesogenic environment.

“I’m always excited to hear some talks that are outside of my comfort area to understand the mechanisms of obesity better,” concluded Dr. Allison.

A version of this article first appeared on Medscape.com.

Researchers have developed a computer program to identify drugs for other diseases that might be repurposed to treat type 2 diabetes and/or obesity by targeting genetic pathways for these two conditions.

The scientists identified four pathways with known drug targets for type 2 diabetes and five with known drug targets for obesity.

Their findings suggest that:

• Palbociclib (used to treat breast cancer) and cardiac glycosides (used to treat heart failure and heart rhythm disorders) might be repurposed to treat type 2 diabetes.
• Baclofen (a muscle relaxant) and carfilzomib (a chemotherapy) could potentially be used to treat obesity.
• Fostamatinib (used to treat thrombocytopenia), sucralfate (used to treat stomach ulcers), and regorafenib (used to treat cancer) might be used to treat type 2 diabetes and obesity.
• Baclofen and sucralfate would have favorable safety profiles as repurposed treatments.

Sahar El Shair, a PhD student at the Faculty of Health and Medicine, University of Newcastle, New South Wales, Australia, presented the research during an oral session at the International Congress on Obesity, the biennial congress of the World Obesity Federation, in Melbourne.

“New treatments with higher activity and specificity are urgently needed to tackle a pandemic of chronic illness associated with type 2 diabetes and obesity,” senior coauthor Murray Cairns, PhD, said in a press release from the ICO.   

“Our technology harnesses genetically informed precision medicine to identify and target new treatments for these complex disorders,” said Dr. Cairns, from the school of biomedical sciences and pharmacy at the University of Newcastle.

Matchmaking between individual, their genetic traits, and drugs

Dr. Cairns and senior coauthor William Reay, PhD, also from the school of biomedical sciences and pharmacy, have cofounded a company called PolygenRx.

The company website explains that they have developed a propriety platform termed the pharmagenic enrichment score (PES), which is “essentially a matchmaking service between patients and drugs, allowing treatment to be optimized for each individual using their unique combination of genetic risk factors.”

It is important to note the genetic risk from complex traits, such as type 2 diabetes and obesity, “are quite different [from] the rare genetic disorders caused mostly by a devastating mutation in a single gene,” Dr. Cairns explained in an email.

“Complex traits,” he noted, “are associated with thousands of [genetic] variants that are common in people and have a cumulative effect.”

For this specific research, the investigators obtained genetic data from genome-wide association studies of obesity and type 2 diabetes.

“By using very large cohorts (hundreds of thousands of individuals) and comparing the frequency of millions of genetic variants in subjects with these conditions with controls, these studies have revealed regions of the genome and genes associated with the condition,” Dr. Cairns noted.

The pharmagenic enrichment score integrates a person’s genetics with drug pharmacology to determine if a person would respond more readily to a certain drug.

“We are investigating the potential of thousands of drugs across a broad spectrum of complex traits (the list is almost endless),” Dr. Cairns explained.

From the PES score, “we have an estimate of each individual’s likelihood of a positive response to said drug,” he noted. “We all have variants that increase (and decrease) the risk of these conditions to various degrees as they are common (high frequency) genetic variants.”

With this research, “we can implement this precision medicine strategy to match the right [repurposed] drugs for individuals based on their specific burden of genetic risk” for obesity and type 2 diabetes.

“Drug repurposing can be a fast track to new medicines because there is existing knowledge about their safety and activity in humans,” he said.

Next steps: Raising funds for clinical trials

“We would like to progress some of these compounds to preclinical and clinical trials,” Dr. Cairns said, “but need to raise the funds for this expensive research. With limited government research funding opportunities, we have recently spun out a startup company to attract commercial investment in our platform and the development of new drug candidates.”

The authors have reported no relevant financial relationships. Dr. Reay and Dr. Cairns are cofounders of PolygenRx.

A version of this article first appeared on Medscape.com.

Researchers have developed a computer program to identify drugs for other diseases that might be repurposed to treat type 2 diabetes and/or obesity by targeting genetic pathways for these two conditions.

The scientists identified four pathways with known drug targets for type 2 diabetes and five with known drug targets for obesity.

Their findings suggest that:

• Palbociclib (used to treat breast cancer) and cardiac glycosides (used to treat heart failure and heart rhythm disorders) might be repurposed to treat type 2 diabetes.
• Baclofen (a muscle relaxant) and carfilzomib (a chemotherapy) could potentially be used to treat obesity.
• Fostamatinib (used to treat thrombocytopenia), sucralfate (used to treat stomach ulcers), and regorafenib (used to treat cancer) might be used to treat type 2 diabetes and obesity.
• Baclofen and sucralfate would have favorable safety profiles as repurposed treatments.

Sahar El Shair, a PhD student at the Faculty of Health and Medicine, University of Newcastle, New South Wales, Australia, presented the research during an oral session at the International Congress on Obesity, the biennial congress of the World Obesity Federation, in Melbourne.

“New treatments with higher activity and specificity are urgently needed to tackle a pandemic of chronic illness associated with type 2 diabetes and obesity,” senior coauthor Murray Cairns, PhD, said in a press release from the ICO.   

“Our technology harnesses genetically informed precision medicine to identify and target new treatments for these complex disorders,” said Dr. Cairns, from the school of biomedical sciences and pharmacy at the University of Newcastle.

Matchmaking between individual, their genetic traits, and drugs

Dr. Cairns and senior coauthor William Reay, PhD, also from the school of biomedical sciences and pharmacy, have cofounded a company called PolygenRx.

The company website explains that they have developed a propriety platform termed the pharmagenic enrichment score (PES), which is “essentially a matchmaking service between patients and drugs, allowing treatment to be optimized for each individual using their unique combination of genetic risk factors.”

It is important to note the genetic risk from complex traits, such as type 2 diabetes and obesity, “are quite different [from] the rare genetic disorders caused mostly by a devastating mutation in a single gene,” Dr. Cairns explained in an email.

“Complex traits,” he noted, “are associated with thousands of [genetic] variants that are common in people and have a cumulative effect.”

For this specific research, the investigators obtained genetic data from genome-wide association studies of obesity and type 2 diabetes.

“By using very large cohorts (hundreds of thousands of individuals) and comparing the frequency of millions of genetic variants in subjects with these conditions with controls, these studies have revealed regions of the genome and genes associated with the condition,” Dr. Cairns noted.

The pharmagenic enrichment score integrates a person’s genetics with drug pharmacology to determine if a person would respond more readily to a certain drug.

“We are investigating the potential of thousands of drugs across a broad spectrum of complex traits (the list is almost endless),” Dr. Cairns explained.

From the PES score, “we have an estimate of each individual’s likelihood of a positive response to said drug,” he noted. “We all have variants that increase (and decrease) the risk of these conditions to various degrees as they are common (high frequency) genetic variants.”

With this research, “we can implement this precision medicine strategy to match the right [repurposed] drugs for individuals based on their specific burden of genetic risk” for obesity and type 2 diabetes.

“Drug repurposing can be a fast track to new medicines because there is existing knowledge about their safety and activity in humans,” he said.

Next steps: Raising funds for clinical trials

“We would like to progress some of these compounds to preclinical and clinical trials,” Dr. Cairns said, “but need to raise the funds for this expensive research. With limited government research funding opportunities, we have recently spun out a startup company to attract commercial investment in our platform and the development of new drug candidates.”

The authors have reported no relevant financial relationships. Dr. Reay and Dr. Cairns are cofounders of PolygenRx.

A version of this article first appeared on Medscape.com.

Researchers have developed a computer program to identify drugs for other diseases that might be repurposed to treat type 2 diabetes and/or obesity by targeting genetic pathways for these two conditions.

The scientists identified four pathways with known drug targets for type 2 diabetes and five with known drug targets for obesity.

Their findings suggest that:

• Palbociclib (used to treat breast cancer) and cardiac glycosides (used to treat heart failure and heart rhythm disorders) might be repurposed to treat type 2 diabetes.
• Baclofen (a muscle relaxant) and carfilzomib (a chemotherapy) could potentially be used to treat obesity.
• Fostamatinib (used to treat thrombocytopenia), sucralfate (used to treat stomach ulcers), and regorafenib (used to treat cancer) might be used to treat type 2 diabetes and obesity.
• Baclofen and sucralfate would have favorable safety profiles as repurposed treatments.

Sahar El Shair, a PhD student at the Faculty of Health and Medicine, University of Newcastle, New South Wales, Australia, presented the research during an oral session at the International Congress on Obesity, the biennial congress of the World Obesity Federation, in Melbourne.

“New treatments with higher activity and specificity are urgently needed to tackle a pandemic of chronic illness associated with type 2 diabetes and obesity,” senior coauthor Murray Cairns, PhD, said in a press release from the ICO.   

“Our technology harnesses genetically informed precision medicine to identify and target new treatments for these complex disorders,” said Dr. Cairns, from the school of biomedical sciences and pharmacy at the University of Newcastle.

Matchmaking between individual, their genetic traits, and drugs

Dr. Cairns and senior coauthor William Reay, PhD, also from the school of biomedical sciences and pharmacy, have cofounded a company called PolygenRx.

The company website explains that they have developed a propriety platform termed the pharmagenic enrichment score (PES), which is “essentially a matchmaking service between patients and drugs, allowing treatment to be optimized for each individual using their unique combination of genetic risk factors.”

It is important to note the genetic risk from complex traits, such as type 2 diabetes and obesity, “are quite different [from] the rare genetic disorders caused mostly by a devastating mutation in a single gene,” Dr. Cairns explained in an email.

“Complex traits,” he noted, “are associated with thousands of [genetic] variants that are common in people and have a cumulative effect.”

For this specific research, the investigators obtained genetic data from genome-wide association studies of obesity and type 2 diabetes.

“By using very large cohorts (hundreds of thousands of individuals) and comparing the frequency of millions of genetic variants in subjects with these conditions with controls, these studies have revealed regions of the genome and genes associated with the condition,” Dr. Cairns noted.

The pharmagenic enrichment score integrates a person’s genetics with drug pharmacology to determine if a person would respond more readily to a certain drug.

“We are investigating the potential of thousands of drugs across a broad spectrum of complex traits (the list is almost endless),” Dr. Cairns explained.

From the PES score, “we have an estimate of each individual’s likelihood of a positive response to said drug,” he noted. “We all have variants that increase (and decrease) the risk of these conditions to various degrees as they are common (high frequency) genetic variants.”

With this research, “we can implement this precision medicine strategy to match the right [repurposed] drugs for individuals based on their specific burden of genetic risk” for obesity and type 2 diabetes.

“Drug repurposing can be a fast track to new medicines because there is existing knowledge about their safety and activity in humans,” he said.

Next steps: Raising funds for clinical trials

“We would like to progress some of these compounds to preclinical and clinical trials,” Dr. Cairns said, “but need to raise the funds for this expensive research. With limited government research funding opportunities, we have recently spun out a startup company to attract commercial investment in our platform and the development of new drug candidates.”

The authors have reported no relevant financial relationships. Dr. Reay and Dr. Cairns are cofounders of PolygenRx.

A version of this article first appeared on Medscape.com.

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.

Key takeaways

• Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
• The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
• Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.

Why this matters

• The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
• The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
• This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.

Study design

• The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
• At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
• Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
• The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.

Key results

• The study cohort averaged 44 years old, and 53% were women.
• During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
• Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
• Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
• Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
• The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.

Limitations

• The dietary information came from participants’ self-reports, which may have produced biased data.
• The study only included information about animal and vegetable cooking oil consumed at home.
• There may have been residual confounding from variables not included in the study.
• The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once. 
• The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.

Disclosures

• The study did not receive commercial funding.
• The authors reported no financial disclosures.

This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.

A version of this article first appeared on Medscape.com.

Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.

Key takeaways

• Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
• The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
• Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.

Why this matters

• The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
• The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
• This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.

Study design

• The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
• At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
• Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
• The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.

Key results

• The study cohort averaged 44 years old, and 53% were women.
• During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
• Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
• Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
• Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
• The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.

Limitations

• The dietary information came from participants’ self-reports, which may have produced biased data.
• The study only included information about animal and vegetable cooking oil consumed at home.
• There may have been residual confounding from variables not included in the study.
• The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once. 
• The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.

Disclosures

• The study did not receive commercial funding.
• The authors reported no financial disclosures.

This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.

A version of this article first appeared on Medscape.com.

Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.

Key takeaways

• Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
• The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
• Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.

Why this matters

• The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
• The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
• This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.

Study design

• The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
• At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
• Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
• The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.

Key results

• The study cohort averaged 44 years old, and 53% were women.
• During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
• Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
• Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
• Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
• The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.

Limitations

• The dietary information came from participants’ self-reports, which may have produced biased data.
• The study only included information about animal and vegetable cooking oil consumed at home.
• There may have been residual confounding from variables not included in the study.
• The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once. 
• The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.

Disclosures

• The study did not receive commercial funding.
• The authors reported no financial disclosures.

This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.

A version of this article first appeared on Medscape.com.

In a small cross-sectional study of 10- to 16-year-old girls with and without type 1 diabetes, both groups were equally physically active, based on their replies to the bone-specific physical activity questionnaire (BPAQ).

However, among the more sedentary girls (with BPAQ scores below the median), those with type 1 diabetes had worse markers of bone health in imaging tests compared with the girls without diabetes.

“The deleterious effect of [type 1 diabetes] on bone health in girls is most pronounced in those with less weight-bearing activity,” the researchers summarize in a poster presented at the annual meeting of the American Society of Bone and Mineral Research.

However, this is early research and further study is needed, the group cautions.

“Ongoing studies with objective measures of physical activity as well as interventional studies will clarify whether increasing physical activity may improve bone health and reduce fracture risk in this vulnerable group,” they conclude.

“If you look at the sedentary kids, there’s a big discrepancy between the kids who have diabetes and the control kids, and that’s if we’re looking at radius or tibia or trabecular bone density or estimated failure load,” senior author Deborah M. Mitchell, MD, said in an interview at the poster session.

However, “when we look at the kids who are more physically active, we’re really not seeing as much difference [in bone health] between the kids with and without diabetes,” said Dr. Mitchell, a pediatric endocrinologist at Massachusetts General Hospital and assistant professor at Harvard Medical School, Boston.

But she also acknowledged, “There’s all sorts of caveats, including that this is retrospective questionnaire data.”

However, if further, rigorous studies confirm these findings, “physical activity is potentially a really effective means of improving bone quality in kids with type 1 diabetes.”

“This study suggests that bone-loading physical activity can substantially improve skeletal health in children with [type 1 diabetes] and should provide hope for patients and their families that they can take some action to prevent or mitigate the effects of diabetes on bone,” coauthor and incoming ASBMR President Mary L. Bouxsein, PhD, told this news organization in an email.

“We interpret these data as an important reason to advocate for increased time in moderate to vigorous bone-loading activity,” said Dr. Bouxsein, professor, department of orthopedic surgery, Harvard Medical School, Boston, “though the ‘dose’ in terms of hours per day or episodes per week to promote optimal bone health is still to be determined.”
 

“Ongoing debate,” “need stronger proof”

Asked for comment, Laura K. Bachrach, MD, who was not involved with the research, noted: “Activity benefits the development of bone strength through effects on bone geometry more than ‘density,’ and conversely, lack of physical activity can compromise gains in cortical bone diameter and thickness.”

However, “there is ongoing debate about the impact of type 1 diabetes on bone health and the factor(s) determining risk,” Dr. Bachrach, a pediatric endocrinologist at Stanford Children’s Health, Palo Alto, Calif., told this news organization in an email.  

The current findings suggest “that physical activity in adolescent girls provided protection against potential adverse effects of type 1 diabetes,” said Dr. Bachrach, who spoke about bone fragility in childhood in a video commentary in 2021.

Study strengths, she noted, “include the rigor and expertise of the investigators, use of multiple surrogate measures that capture bone geometry/microarchitecture, as well as the inclusion of healthy local controls.”  

“The study is limited by the cross-sectional design and subjects who opted, or not, to be active,” she added. “Stronger proof of the protective effects of activity on bone health in type 1 diabetes would require a randomized longitudinal intervention study, as alluded to by the authors of the study.”
 

Hypothesis: Those with type 1 diabetes acquire less bone mass in early 20s

The excess fracture risk in children with type 1 diabetes has been previously reported and is 14%-35% higher than the fracture risk in children without diabetes, Dr. Bouxsein explained. And “between 30% to 50% of kids [with type 1 diabetes] will have a fracture before the age of 18, so the excess fracture risk in diabetes is not clinically obvious,” she added.

However, “several lines of evidence strongly suggest that bone mass and microarchitecture at the time of peak bone mass (early 20s) is a major determinant of fracture risk throughout the lifespan,” she noted.

“Our hypothesis,” Dr. Bouxsein said, “is that the metabolic disruptions of diabetes, when they are present during the acquisition of peak bone mass, interfere with optimal bone development, and therefore may contribute to increased fracture risk later in life.”

Dr. Bachrach agreed that “peak bone strength is achieved by early adulthood, making childhood and adolescence important times to optimize bone health,” and that “peak bone strength is a predictor of lifetime risk of osteoporosis.”

“The diagnosis of pediatric osteoporosis is made when a child or teen sustains a vertebral fracture or femur fracture with minimal or no trauma,” she explained. “The diagnosis can also be made in a pediatric patient with low BMD [bone mineral density] for age in combination with a history of several long-bone fractures.”

Dr. Mitchell noted that type 1 diabetes is associated with a higher risk of fractures, which is sixfold in adults. In another study, she said, the group showed that in 10- to 16-year-old girls who’ve only had diabetes for a few years, “trabecular bone density is lower, they have lower estimated failure load, and longitudinally when we follow them, at least at the radius, we’re seeing bone loss at a relatively young age when we wouldn’t be expecting to see bone loss.”
 

80 girls enrolled, half had type 1 diabetes

Researchers enrolled 36 girls with type 1 diabetes and 44 girls without type 1 diabetes (controls) who were a mean age of 14.7 years and most (92%) were White. The girls with and without diabetes had similar rates of previous fractures (44% and 51%).

Those with diabetes had been diagnosed at a mean age of 9 years and had had diabetes for a mean of 4.6 years.

Researchers calculated participants’ total BPAQ scores based on type, duration, and frequency of bone-loading activities. 

Participants had dual-energy X-ray absorptiometry scans to determine areal bone mineral density (BMD) at the total hip, femoral neck, lumbar spine, and whole body less head.

They also had high-resolution peripheral quantitative computed tomography at the distal tibia and radius to determine volumetric BMD, bone microarchitecture, and estimated bone strength (calculated using microfinite element analysis).

The two groups had similar total BPAQ scores (57.3 and 64.6), with a median score of 49.

BPAQ scores were positively associated with areal BMD at all sites (whole body, lumbar spine, total hip, femoral neck, and 1/3 radius) and with trabecular BMD and estimated failure load at the distal radius and tibia (P < .05 for all, adjusted for bone age).

Among participants with low physical activity (BPAQ below the median), compared with controls, those with type 1 diabetes had 6.6% lower aerial BMD at the lumbar spine (0.868 vs. 0.929 g/cm³; P = .04), 8% lower trabecular volumetric BMD at the distal radius (128.5 vs. 156.8 mg/cm³; P = .01), and 12% lower estimated failure load. Results at the distal tibia were similar.
 

Next steps

“More observational studies in males and females across a broader age spectrum would be helpful,” Dr. Bachrach noted. “The ‘gold standard’ model would be a long-term randomized controlled activity intervention study.”

“Further studies are underway [in girls and boys] using objective measures of activity including accelerometry and longitudinal observation to help confirm the findings from the current study,” Dr. Bouxsein said. “Ultimately, trials of activity interventions in children with [type 1 diabetes] will be the gold standard to determine to what extent physical activity can mitigate bone disease in [type 1 diabetes],” she agreed.

The study authors and Dr. Bachrach have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a small cross-sectional study of 10- to 16-year-old girls with and without type 1 diabetes, both groups were equally physically active, based on their replies to the bone-specific physical activity questionnaire (BPAQ).

However, among the more sedentary girls (with BPAQ scores below the median), those with type 1 diabetes had worse markers of bone health in imaging tests compared with the girls without diabetes.

“The deleterious effect of [type 1 diabetes] on bone health in girls is most pronounced in those with less weight-bearing activity,” the researchers summarize in a poster presented at the annual meeting of the American Society of Bone and Mineral Research.

However, this is early research and further study is needed, the group cautions.

“Ongoing studies with objective measures of physical activity as well as interventional studies will clarify whether increasing physical activity may improve bone health and reduce fracture risk in this vulnerable group,” they conclude.

“If you look at the sedentary kids, there’s a big discrepancy between the kids who have diabetes and the control kids, and that’s if we’re looking at radius or tibia or trabecular bone density or estimated failure load,” senior author Deborah M. Mitchell, MD, said in an interview at the poster session.

However, “when we look at the kids who are more physically active, we’re really not seeing as much difference [in bone health] between the kids with and without diabetes,” said Dr. Mitchell, a pediatric endocrinologist at Massachusetts General Hospital and assistant professor at Harvard Medical School, Boston.

But she also acknowledged, “There’s all sorts of caveats, including that this is retrospective questionnaire data.”

However, if further, rigorous studies confirm these findings, “physical activity is potentially a really effective means of improving bone quality in kids with type 1 diabetes.”

“This study suggests that bone-loading physical activity can substantially improve skeletal health in children with [type 1 diabetes] and should provide hope for patients and their families that they can take some action to prevent or mitigate the effects of diabetes on bone,” coauthor and incoming ASBMR President Mary L. Bouxsein, PhD, told this news organization in an email.

“We interpret these data as an important reason to advocate for increased time in moderate to vigorous bone-loading activity,” said Dr. Bouxsein, professor, department of orthopedic surgery, Harvard Medical School, Boston, “though the ‘dose’ in terms of hours per day or episodes per week to promote optimal bone health is still to be determined.”
 

“Ongoing debate,” “need stronger proof”

Asked for comment, Laura K. Bachrach, MD, who was not involved with the research, noted: “Activity benefits the development of bone strength through effects on bone geometry more than ‘density,’ and conversely, lack of physical activity can compromise gains in cortical bone diameter and thickness.”

However, “there is ongoing debate about the impact of type 1 diabetes on bone health and the factor(s) determining risk,” Dr. Bachrach, a pediatric endocrinologist at Stanford Children’s Health, Palo Alto, Calif., told this news organization in an email.  

The current findings suggest “that physical activity in adolescent girls provided protection against potential adverse effects of type 1 diabetes,” said Dr. Bachrach, who spoke about bone fragility in childhood in a video commentary in 2021.

Study strengths, she noted, “include the rigor and expertise of the investigators, use of multiple surrogate measures that capture bone geometry/microarchitecture, as well as the inclusion of healthy local controls.”  

“The study is limited by the cross-sectional design and subjects who opted, or not, to be active,” she added. “Stronger proof of the protective effects of activity on bone health in type 1 diabetes would require a randomized longitudinal intervention study, as alluded to by the authors of the study.”
 

Hypothesis: Those with type 1 diabetes acquire less bone mass in early 20s

The excess fracture risk in children with type 1 diabetes has been previously reported and is 14%-35% higher than the fracture risk in children without diabetes, Dr. Bouxsein explained. And “between 30% to 50% of kids [with type 1 diabetes] will have a fracture before the age of 18, so the excess fracture risk in diabetes is not clinically obvious,” she added.

However, “several lines of evidence strongly suggest that bone mass and microarchitecture at the time of peak bone mass (early 20s) is a major determinant of fracture risk throughout the lifespan,” she noted.

“Our hypothesis,” Dr. Bouxsein said, “is that the metabolic disruptions of diabetes, when they are present during the acquisition of peak bone mass, interfere with optimal bone development, and therefore may contribute to increased fracture risk later in life.”

Dr. Bachrach agreed that “peak bone strength is achieved by early adulthood, making childhood and adolescence important times to optimize bone health,” and that “peak bone strength is a predictor of lifetime risk of osteoporosis.”

“The diagnosis of pediatric osteoporosis is made when a child or teen sustains a vertebral fracture or femur fracture with minimal or no trauma,” she explained. “The diagnosis can also be made in a pediatric patient with low BMD [bone mineral density] for age in combination with a history of several long-bone fractures.”

Dr. Mitchell noted that type 1 diabetes is associated with a higher risk of fractures, which is sixfold in adults. In another study, she said, the group showed that in 10- to 16-year-old girls who’ve only had diabetes for a few years, “trabecular bone density is lower, they have lower estimated failure load, and longitudinally when we follow them, at least at the radius, we’re seeing bone loss at a relatively young age when we wouldn’t be expecting to see bone loss.”
 

80 girls enrolled, half had type 1 diabetes

Researchers enrolled 36 girls with type 1 diabetes and 44 girls without type 1 diabetes (controls) who were a mean age of 14.7 years and most (92%) were White. The girls with and without diabetes had similar rates of previous fractures (44% and 51%).

Those with diabetes had been diagnosed at a mean age of 9 years and had had diabetes for a mean of 4.6 years.

Researchers calculated participants’ total BPAQ scores based on type, duration, and frequency of bone-loading activities. 

Participants had dual-energy X-ray absorptiometry scans to determine areal bone mineral density (BMD) at the total hip, femoral neck, lumbar spine, and whole body less head.

They also had high-resolution peripheral quantitative computed tomography at the distal tibia and radius to determine volumetric BMD, bone microarchitecture, and estimated bone strength (calculated using microfinite element analysis).

The two groups had similar total BPAQ scores (57.3 and 64.6), with a median score of 49.

BPAQ scores were positively associated with areal BMD at all sites (whole body, lumbar spine, total hip, femoral neck, and 1/3 radius) and with trabecular BMD and estimated failure load at the distal radius and tibia (P < .05 for all, adjusted for bone age).

Among participants with low physical activity (BPAQ below the median), compared with controls, those with type 1 diabetes had 6.6% lower aerial BMD at the lumbar spine (0.868 vs. 0.929 g/cm³; P = .04), 8% lower trabecular volumetric BMD at the distal radius (128.5 vs. 156.8 mg/cm³; P = .01), and 12% lower estimated failure load. Results at the distal tibia were similar.
 

Next steps

“More observational studies in males and females across a broader age spectrum would be helpful,” Dr. Bachrach noted. “The ‘gold standard’ model would be a long-term randomized controlled activity intervention study.”

“Further studies are underway [in girls and boys] using objective measures of activity including accelerometry and longitudinal observation to help confirm the findings from the current study,” Dr. Bouxsein said. “Ultimately, trials of activity interventions in children with [type 1 diabetes] will be the gold standard to determine to what extent physical activity can mitigate bone disease in [type 1 diabetes],” she agreed.

The study authors and Dr. Bachrach have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a small cross-sectional study of 10- to 16-year-old girls with and without type 1 diabetes, both groups were equally physically active, based on their replies to the bone-specific physical activity questionnaire (BPAQ).

However, among the more sedentary girls (with BPAQ scores below the median), those with type 1 diabetes had worse markers of bone health in imaging tests compared with the girls without diabetes.

“The deleterious effect of [type 1 diabetes] on bone health in girls is most pronounced in those with less weight-bearing activity,” the researchers summarize in a poster presented at the annual meeting of the American Society of Bone and Mineral Research.

However, this is early research and further study is needed, the group cautions.

“Ongoing studies with objective measures of physical activity as well as interventional studies will clarify whether increasing physical activity may improve bone health and reduce fracture risk in this vulnerable group,” they conclude.

“If you look at the sedentary kids, there’s a big discrepancy between the kids who have diabetes and the control kids, and that’s if we’re looking at radius or tibia or trabecular bone density or estimated failure load,” senior author Deborah M. Mitchell, MD, said in an interview at the poster session.

However, “when we look at the kids who are more physically active, we’re really not seeing as much difference [in bone health] between the kids with and without diabetes,” said Dr. Mitchell, a pediatric endocrinologist at Massachusetts General Hospital and assistant professor at Harvard Medical School, Boston.

But she also acknowledged, “There’s all sorts of caveats, including that this is retrospective questionnaire data.”

However, if further, rigorous studies confirm these findings, “physical activity is potentially a really effective means of improving bone quality in kids with type 1 diabetes.”

“This study suggests that bone-loading physical activity can substantially improve skeletal health in children with [type 1 diabetes] and should provide hope for patients and their families that they can take some action to prevent or mitigate the effects of diabetes on bone,” coauthor and incoming ASBMR President Mary L. Bouxsein, PhD, told this news organization in an email.

“We interpret these data as an important reason to advocate for increased time in moderate to vigorous bone-loading activity,” said Dr. Bouxsein, professor, department of orthopedic surgery, Harvard Medical School, Boston, “though the ‘dose’ in terms of hours per day or episodes per week to promote optimal bone health is still to be determined.”
 

“Ongoing debate,” “need stronger proof”

Asked for comment, Laura K. Bachrach, MD, who was not involved with the research, noted: “Activity benefits the development of bone strength through effects on bone geometry more than ‘density,’ and conversely, lack of physical activity can compromise gains in cortical bone diameter and thickness.”

However, “there is ongoing debate about the impact of type 1 diabetes on bone health and the factor(s) determining risk,” Dr. Bachrach, a pediatric endocrinologist at Stanford Children’s Health, Palo Alto, Calif., told this news organization in an email.  

The current findings suggest “that physical activity in adolescent girls provided protection against potential adverse effects of type 1 diabetes,” said Dr. Bachrach, who spoke about bone fragility in childhood in a video commentary in 2021.

Study strengths, she noted, “include the rigor and expertise of the investigators, use of multiple surrogate measures that capture bone geometry/microarchitecture, as well as the inclusion of healthy local controls.”  

“The study is limited by the cross-sectional design and subjects who opted, or not, to be active,” she added. “Stronger proof of the protective effects of activity on bone health in type 1 diabetes would require a randomized longitudinal intervention study, as alluded to by the authors of the study.”
 

Hypothesis: Those with type 1 diabetes acquire less bone mass in early 20s

The excess fracture risk in children with type 1 diabetes has been previously reported and is 14%-35% higher than the fracture risk in children without diabetes, Dr. Bouxsein explained. And “between 30% to 50% of kids [with type 1 diabetes] will have a fracture before the age of 18, so the excess fracture risk in diabetes is not clinically obvious,” she added.

However, “several lines of evidence strongly suggest that bone mass and microarchitecture at the time of peak bone mass (early 20s) is a major determinant of fracture risk throughout the lifespan,” she noted.

“Our hypothesis,” Dr. Bouxsein said, “is that the metabolic disruptions of diabetes, when they are present during the acquisition of peak bone mass, interfere with optimal bone development, and therefore may contribute to increased fracture risk later in life.”

Dr. Bachrach agreed that “peak bone strength is achieved by early adulthood, making childhood and adolescence important times to optimize bone health,” and that “peak bone strength is a predictor of lifetime risk of osteoporosis.”

“The diagnosis of pediatric osteoporosis is made when a child or teen sustains a vertebral fracture or femur fracture with minimal or no trauma,” she explained. “The diagnosis can also be made in a pediatric patient with low BMD [bone mineral density] for age in combination with a history of several long-bone fractures.”

Dr. Mitchell noted that type 1 diabetes is associated with a higher risk of fractures, which is sixfold in adults. In another study, she said, the group showed that in 10- to 16-year-old girls who’ve only had diabetes for a few years, “trabecular bone density is lower, they have lower estimated failure load, and longitudinally when we follow them, at least at the radius, we’re seeing bone loss at a relatively young age when we wouldn’t be expecting to see bone loss.”
 

80 girls enrolled, half had type 1 diabetes

Researchers enrolled 36 girls with type 1 diabetes and 44 girls without type 1 diabetes (controls) who were a mean age of 14.7 years and most (92%) were White. The girls with and without diabetes had similar rates of previous fractures (44% and 51%).

Those with diabetes had been diagnosed at a mean age of 9 years and had had diabetes for a mean of 4.6 years.

Researchers calculated participants’ total BPAQ scores based on type, duration, and frequency of bone-loading activities. 

Participants had dual-energy X-ray absorptiometry scans to determine areal bone mineral density (BMD) at the total hip, femoral neck, lumbar spine, and whole body less head.

They also had high-resolution peripheral quantitative computed tomography at the distal tibia and radius to determine volumetric BMD, bone microarchitecture, and estimated bone strength (calculated using microfinite element analysis).

The two groups had similar total BPAQ scores (57.3 and 64.6), with a median score of 49.

BPAQ scores were positively associated with areal BMD at all sites (whole body, lumbar spine, total hip, femoral neck, and 1/3 radius) and with trabecular BMD and estimated failure load at the distal radius and tibia (P < .05 for all, adjusted for bone age).

Among participants with low physical activity (BPAQ below the median), compared with controls, those with type 1 diabetes had 6.6% lower aerial BMD at the lumbar spine (0.868 vs. 0.929 g/cm³; P = .04), 8% lower trabecular volumetric BMD at the distal radius (128.5 vs. 156.8 mg/cm³; P = .01), and 12% lower estimated failure load. Results at the distal tibia were similar.
 

Next steps

“More observational studies in males and females across a broader age spectrum would be helpful,” Dr. Bachrach noted. “The ‘gold standard’ model would be a long-term randomized controlled activity intervention study.”

“Further studies are underway [in girls and boys] using objective measures of activity including accelerometry and longitudinal observation to help confirm the findings from the current study,” Dr. Bouxsein said. “Ultimately, trials of activity interventions in children with [type 1 diabetes] will be the gold standard to determine to what extent physical activity can mitigate bone disease in [type 1 diabetes],” she agreed.

The study authors and Dr. Bachrach have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.

Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.

The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).

Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
 

‘We should worry about the bones as well as the liver’

Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.

“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”

“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.

However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.

“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.

“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.

“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”

Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.

“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.

Now this new study has found an increase in fractures in such people, he noted.
 

Large case-control study used U.K. database

Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.

They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.

Patients were a mean age of 59 years and 59% were men.

During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).

In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.

Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).

Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.

Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).

Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.

Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).

Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.

The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.

The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.

Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.

The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).

Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
 

‘We should worry about the bones as well as the liver’

Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.

“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”

“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.

However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.

“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.

“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.

“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”

Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.

“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.

Now this new study has found an increase in fractures in such people, he noted.
 

Large case-control study used U.K. database

Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.

They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.

Patients were a mean age of 59 years and 59% were men.

During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).

In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.

Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).

Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.

Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).

Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.

Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).

Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.

The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.

The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.

Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.

The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).

Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
 

‘We should worry about the bones as well as the liver’

Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.

“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”

“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.

However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.

“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.

“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.

“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”

Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.

“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.

Now this new study has found an increase in fractures in such people, he noted.
 

Large case-control study used U.K. database

Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.

They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.

Patients were a mean age of 59 years and 59% were men.

During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).

In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.

Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).

Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.

Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).

Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.

Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).

Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.

The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.

The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

A version of this article first appeared on Medscape.com.

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

A version of this article first appeared on Medscape.com.

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

A version of this article first appeared on Medscape.com.

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

A version of this article first appeared on Medscape.com.

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

A version of this article first appeared on Medscape.com.

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

A version of this article first appeared on Medscape.com.

Omega-3 supplements did not reduce fractures during a median 5.3-year follow-up in the more than 25,000 generally healthy men and women (≥ age 50 and ≥ age 55, respectively) in the Vitamin D and Omega-3 Trial (VITAL).

The large randomized controlled trial tested whether omega-3 fatty acid or vitamin D supplements prevented cardiovascular disease or cancer in a representative sample of midlife and older adults from 50 U.S. states – which they did not. In a further analysis of VITAL, vitamin D supplements (cholecalciferol, 2,000 IU/day) did not lower the risk of incident total, nonvertebral, and hip fractures, compared with placebo.

Dmitriy Danilchenko/Shutterstock

Now this new analysis shows that omega-3 fatty acid supplements (1 g/day of fish oil) did not reduce the risk of such fractures in the VITAL population either. Meryl S. LeBoff, MD, presented the latest findings during an oral session at the annual meeting of the American Society for Bone and Mineral Research.

“In this, the largest randomized controlled trial in the world, we did not find an effect of omega-3 fatty acid supplements on fractures,” Dr. LeBoff, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, told this news organization.

The current analysis did “unexpectedly” show that among participants who received the omega-3 fatty acid supplements, there was an increase in fractures in men, and fracture risk was higher in people with a normal or low body mass index and lower in people with higher BMI.

However, these subgroup findings need to be interpreted with caution and may be caused by chance, Dr. LeBoff warned. The researchers will be investigating these findings in further analyses.
 

Should patients take omega-3 supplements or not?

Asked whether, in the meantime, patients should start or keep taking fish oil supplements for possible health benefits, she noted that certain individuals might benefit.

For example, in VITAL, participants who ate less than 1.5 servings of fish per week and received omega-3 fatty acid supplements had a decrease in the combined cardiovascular endpoint, and Black participants who took fish oil supplements had a substantially reduced risk of the outcome, regardless of fish intake.

“I think everybody needs to review [the study findings] with clinicians and make a decision in terms of what would be best for them,” she said.

Session comoderator Bente Langdahl, MD, PhD, commented that “many people take omega-3 because they think it will help” knee, hip, or other joint pain.

Perhaps men are more prone to joint pain because of osteoarthritis and the supplements lessen the pain, so these men became more physically active and more prone to fractures, she speculated.

The current study shows that, “so far, we haven’t been able to demonstrate a reduced rate of fractures with fish oil supplements in clinical randomized trials” conducted in relatively healthy and not the oldest patients, she summarized. “We’re not talking about 80-year-olds.”

In this “well-conducted study, they were not able to see any difference” with omega-3 fatty acid supplements versus placebo, but apparently, there are no harms associated with taking these supplements, she said.

To patients who ask her about such supplements, Dr. Langdahl advised: “Try it out for 3 months. If it really helps you, if it takes away your joint pain or whatever, then that might work for you. But then remember to stop again because it might just be a temporary effect.”
 

Could fish oil supplements protect against fractures?

An estimated 22% of U.S. adults aged 60 and older take omega-3 fatty acid supplements, Dr. LeBoff noted.

Preclinical studies have shown that omega-3 fatty acids reduce bone resorption and have anti-inflammatory effects, but observational studies have reported conflicting findings.

The researchers conducted this ancillary study of VITAL to fill these knowledge gaps.

VITAL enrolled a national sample of 25,871 U.S. men and women, including 5,106 Black participants, with a mean age of 67 and a mean BMI of 28 kg/m2.

Importantly, participants were not recruited by low bone density, fractures, or vitamin D deficiency. Prior to entry, participants were required to stop taking omega-3 supplements and limit nonstudy vitamin D and calcium supplements.

The omega-3 fatty acid supplements used in the study contained eicosapentaenoic acid and docosahexaenoic acid in a 1.2:1 ratio.

VITAL had a 2x2 factorial design whereby 6,463 participants were randomized to receive the omega-3 fatty acid supplement and 6,474 were randomized to placebo. (Remaining participants were randomized to receive vitamin D or placebo.)

Participants in the omega-3 fatty acid and placebo groups had similar baseline characteristics. For example, about half (50.5%) were women, and on average, they ate 1.1 servings of dark-meat fish (such as salmon) per week.

Participants completed detailed questionnaires at baseline and each year.

Plasma omega-3 levels were measured at baseline and, in 1,583 participants, at 1 year of follow-up. The mean omega-3 index rose 54.7% in the omega-3 fatty acid group and changed less than 2% in the placebo group at 1 year.

Study pill adherence was 87.0% at 2 years and 85.7% at 5 years.

Fractures were self-reported on annual questionnaires and centrally adjudicated in medical record review.
 

No clinically meaningful effect of omega-3 fatty acids on fractures

During a median 5.3-year follow-up, researchers adjudicated 2,133 total fractures and confirmed 1,991 fractures (93%) in 1551 participants.

Incidences of total, nonvertebral, and hip fractures were similar in both groups.

Compared with placebo, omega-3 fatty acid supplements had no significant effect on risk of total fractures (hazard ratio, 1.02; 95% confidence interval, 0.92-1.13), nonvertebral fractures (HR, 1.01; 95% CI, 0.91-1.12), or hip fractures (HR, 0.89; 95% CI, 0.61-1.30), all adjusted for age, sex, and race.

The “confidence intervals were narrow, likely excluding a clinically meaningful effect,” Dr. LeBoff noted.

Among men, those who received fish oil supplements had a greater risk of fracture than those who received placebo (HR, 1.27; 95% CI, 1.07-1.51), but this result “was not corrected for multiple hypothesis testing,” Dr. LeBoff cautioned.

In the overall population, participants with a BMI less than 25 who received fish oil versus placebo had an increased risk of fracture, and those with a BMI of at least 30 who received fish oil versus placebo had a decreased risk of fracture, but the limits of the confidence intervals crossed 1.00.

After excluding digit, skull, and pathologic fractures, there was no significant reduction in total fractures (HR, 1.02; 95% CI, 0.92-1.14), nonvertebral fractures (HR, 1.02; 95% CI, 0.92-1.14), or hip fractures (HR, 0.90; 95% CI, 0.61-1.33), with omega-3 supplements versus placebo.

Similarly, there was no significant reduction in risk of major osteoporotic fractures (hip, wrist, humerus, and clinical spine fractures) or wrist fractures with omega-3 supplements versus placebo.

VITAL only studied one dose of omega-3 fatty acid supplements, and results may not be generalizable to younger adults, or older adults living in residential communities, Dr. LeBoff noted.

The study was supported by grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. VITAL was funded by the National Cancer Institute and the National Heart, Lung, and Blood Institute. Dr. LeBoff and Dr. Langdahl have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Omega-3 supplements did not reduce fractures during a median 5.3-year follow-up in the more than 25,000 generally healthy men and women (≥ age 50 and ≥ age 55, respectively) in the Vitamin D and Omega-3 Trial (VITAL).

The large randomized controlled trial tested whether omega-3 fatty acid or vitamin D supplements prevented cardiovascular disease or cancer in a representative sample of midlife and older adults from 50 U.S. states – which they did not. In a further analysis of VITAL, vitamin D supplements (cholecalciferol, 2,000 IU/day) did not lower the risk of incident total, nonvertebral, and hip fractures, compared with placebo.

Dmitriy Danilchenko/Shutterstock

Now this new analysis shows that omega-3 fatty acid supplements (1 g/day of fish oil) did not reduce the risk of such fractures in the VITAL population either. Meryl S. LeBoff, MD, presented the latest findings during an oral session at the annual meeting of the American Society for Bone and Mineral Research.

“In this, the largest randomized controlled trial in the world, we did not find an effect of omega-3 fatty acid supplements on fractures,” Dr. LeBoff, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, told this news organization.

The current analysis did “unexpectedly” show that among participants who received the omega-3 fatty acid supplements, there was an increase in fractures in men, and fracture risk was higher in people with a normal or low body mass index and lower in people with higher BMI.

However, these subgroup findings need to be interpreted with caution and may be caused by chance, Dr. LeBoff warned. The researchers will be investigating these findings in further analyses.
 

Should patients take omega-3 supplements or not?

Asked whether, in the meantime, patients should start or keep taking fish oil supplements for possible health benefits, she noted that certain individuals might benefit.

For example, in VITAL, participants who ate less than 1.5 servings of fish per week and received omega-3 fatty acid supplements had a decrease in the combined cardiovascular endpoint, and Black participants who took fish oil supplements had a substantially reduced risk of the outcome, regardless of fish intake.

“I think everybody needs to review [the study findings] with clinicians and make a decision in terms of what would be best for them,” she said.

Session comoderator Bente Langdahl, MD, PhD, commented that “many people take omega-3 because they think it will help” knee, hip, or other joint pain.

Perhaps men are more prone to joint pain because of osteoarthritis and the supplements lessen the pain, so these men became more physically active and more prone to fractures, she speculated.

The current study shows that, “so far, we haven’t been able to demonstrate a reduced rate of fractures with fish oil supplements in clinical randomized trials” conducted in relatively healthy and not the oldest patients, she summarized. “We’re not talking about 80-year-olds.”

In this “well-conducted study, they were not able to see any difference” with omega-3 fatty acid supplements versus placebo, but apparently, there are no harms associated with taking these supplements, she said.

To patients who ask her about such supplements, Dr. Langdahl advised: “Try it out for 3 months. If it really helps you, if it takes away your joint pain or whatever, then that might work for you. But then remember to stop again because it might just be a temporary effect.”
 

Could fish oil supplements protect against fractures?

An estimated 22% of U.S. adults aged 60 and older take omega-3 fatty acid supplements, Dr. LeBoff noted.

Preclinical studies have shown that omega-3 fatty acids reduce bone resorption and have anti-inflammatory effects, but observational studies have reported conflicting findings.

The researchers conducted this ancillary study of VITAL to fill these knowledge gaps.

VITAL enrolled a national sample of 25,871 U.S. men and women, including 5,106 Black participants, with a mean age of 67 and a mean BMI of 28 kg/m2.

Importantly, participants were not recruited by low bone density, fractures, or vitamin D deficiency. Prior to entry, participants were required to stop taking omega-3 supplements and limit nonstudy vitamin D and calcium supplements.

The omega-3 fatty acid supplements used in the study contained eicosapentaenoic acid and docosahexaenoic acid in a 1.2:1 ratio.

VITAL had a 2x2 factorial design whereby 6,463 participants were randomized to receive the omega-3 fatty acid supplement and 6,474 were randomized to placebo. (Remaining participants were randomized to receive vitamin D or placebo.)

Participants in the omega-3 fatty acid and placebo groups had similar baseline characteristics. For example, about half (50.5%) were women, and on average, they ate 1.1 servings of dark-meat fish (such as salmon) per week.

Participants completed detailed questionnaires at baseline and each year.

Plasma omega-3 levels were measured at baseline and, in 1,583 participants, at 1 year of follow-up. The mean omega-3 index rose 54.7% in the omega-3 fatty acid group and changed less than 2% in the placebo group at 1 year.

Study pill adherence was 87.0% at 2 years and 85.7% at 5 years.

Fractures were self-reported on annual questionnaires and centrally adjudicated in medical record review.
 

No clinically meaningful effect of omega-3 fatty acids on fractures

During a median 5.3-year follow-up, researchers adjudicated 2,133 total fractures and confirmed 1,991 fractures (93%) in 1551 participants.

Incidences of total, nonvertebral, and hip fractures were similar in both groups.

Compared with placebo, omega-3 fatty acid supplements had no significant effect on risk of total fractures (hazard ratio, 1.02; 95% confidence interval, 0.92-1.13), nonvertebral fractures (HR, 1.01; 95% CI, 0.91-1.12), or hip fractures (HR, 0.89; 95% CI, 0.61-1.30), all adjusted for age, sex, and race.

The “confidence intervals were narrow, likely excluding a clinically meaningful effect,” Dr. LeBoff noted.

Among men, those who received fish oil supplements had a greater risk of fracture than those who received placebo (HR, 1.27; 95% CI, 1.07-1.51), but this result “was not corrected for multiple hypothesis testing,” Dr. LeBoff cautioned.

In the overall population, participants with a BMI less than 25 who received fish oil versus placebo had an increased risk of fracture, and those with a BMI of at least 30 who received fish oil versus placebo had a decreased risk of fracture, but the limits of the confidence intervals crossed 1.00.

After excluding digit, skull, and pathologic fractures, there was no significant reduction in total fractures (HR, 1.02; 95% CI, 0.92-1.14), nonvertebral fractures (HR, 1.02; 95% CI, 0.92-1.14), or hip fractures (HR, 0.90; 95% CI, 0.61-1.33), with omega-3 supplements versus placebo.

Similarly, there was no significant reduction in risk of major osteoporotic fractures (hip, wrist, humerus, and clinical spine fractures) or wrist fractures with omega-3 supplements versus placebo.

VITAL only studied one dose of omega-3 fatty acid supplements, and results may not be generalizable to younger adults, or older adults living in residential communities, Dr. LeBoff noted.

The study was supported by grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. VITAL was funded by the National Cancer Institute and the National Heart, Lung, and Blood Institute. Dr. LeBoff and Dr. Langdahl have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Omega-3 supplements did not reduce fractures during a median 5.3-year follow-up in the more than 25,000 generally healthy men and women (≥ age 50 and ≥ age 55, respectively) in the Vitamin D and Omega-3 Trial (VITAL).

The large randomized controlled trial tested whether omega-3 fatty acid or vitamin D supplements prevented cardiovascular disease or cancer in a representative sample of midlife and older adults from 50 U.S. states – which they did not. In a further analysis of VITAL, vitamin D supplements (cholecalciferol, 2,000 IU/day) did not lower the risk of incident total, nonvertebral, and hip fractures, compared with placebo.

Dmitriy Danilchenko/Shutterstock

Now this new analysis shows that omega-3 fatty acid supplements (1 g/day of fish oil) did not reduce the risk of such fractures in the VITAL population either. Meryl S. LeBoff, MD, presented the latest findings during an oral session at the annual meeting of the American Society for Bone and Mineral Research.

“In this, the largest randomized controlled trial in the world, we did not find an effect of omega-3 fatty acid supplements on fractures,” Dr. LeBoff, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, told this news organization.

The current analysis did “unexpectedly” show that among participants who received the omega-3 fatty acid supplements, there was an increase in fractures in men, and fracture risk was higher in people with a normal or low body mass index and lower in people with higher BMI.

However, these subgroup findings need to be interpreted with caution and may be caused by chance, Dr. LeBoff warned. The researchers will be investigating these findings in further analyses.
 

Should patients take omega-3 supplements or not?

Asked whether, in the meantime, patients should start or keep taking fish oil supplements for possible health benefits, she noted that certain individuals might benefit.

For example, in VITAL, participants who ate less than 1.5 servings of fish per week and received omega-3 fatty acid supplements had a decrease in the combined cardiovascular endpoint, and Black participants who took fish oil supplements had a substantially reduced risk of the outcome, regardless of fish intake.

“I think everybody needs to review [the study findings] with clinicians and make a decision in terms of what would be best for them,” she said.

Session comoderator Bente Langdahl, MD, PhD, commented that “many people take omega-3 because they think it will help” knee, hip, or other joint pain.

Perhaps men are more prone to joint pain because of osteoarthritis and the supplements lessen the pain, so these men became more physically active and more prone to fractures, she speculated.

The current study shows that, “so far, we haven’t been able to demonstrate a reduced rate of fractures with fish oil supplements in clinical randomized trials” conducted in relatively healthy and not the oldest patients, she summarized. “We’re not talking about 80-year-olds.”

In this “well-conducted study, they were not able to see any difference” with omega-3 fatty acid supplements versus placebo, but apparently, there are no harms associated with taking these supplements, she said.

To patients who ask her about such supplements, Dr. Langdahl advised: “Try it out for 3 months. If it really helps you, if it takes away your joint pain or whatever, then that might work for you. But then remember to stop again because it might just be a temporary effect.”
 

Could fish oil supplements protect against fractures?

An estimated 22% of U.S. adults aged 60 and older take omega-3 fatty acid supplements, Dr. LeBoff noted.

Preclinical studies have shown that omega-3 fatty acids reduce bone resorption and have anti-inflammatory effects, but observational studies have reported conflicting findings.

The researchers conducted this ancillary study of VITAL to fill these knowledge gaps.

VITAL enrolled a national sample of 25,871 U.S. men and women, including 5,106 Black participants, with a mean age of 67 and a mean BMI of 28 kg/m2.

Importantly, participants were not recruited by low bone density, fractures, or vitamin D deficiency. Prior to entry, participants were required to stop taking omega-3 supplements and limit nonstudy vitamin D and calcium supplements.

The omega-3 fatty acid supplements used in the study contained eicosapentaenoic acid and docosahexaenoic acid in a 1.2:1 ratio.

VITAL had a 2x2 factorial design whereby 6,463 participants were randomized to receive the omega-3 fatty acid supplement and 6,474 were randomized to placebo. (Remaining participants were randomized to receive vitamin D or placebo.)

Participants in the omega-3 fatty acid and placebo groups had similar baseline characteristics. For example, about half (50.5%) were women, and on average, they ate 1.1 servings of dark-meat fish (such as salmon) per week.

Participants completed detailed questionnaires at baseline and each year.

Plasma omega-3 levels were measured at baseline and, in 1,583 participants, at 1 year of follow-up. The mean omega-3 index rose 54.7% in the omega-3 fatty acid group and changed less than 2% in the placebo group at 1 year.

Study pill adherence was 87.0% at 2 years and 85.7% at 5 years.

Fractures were self-reported on annual questionnaires and centrally adjudicated in medical record review.
 

No clinically meaningful effect of omega-3 fatty acids on fractures

During a median 5.3-year follow-up, researchers adjudicated 2,133 total fractures and confirmed 1,991 fractures (93%) in 1551 participants.

Incidences of total, nonvertebral, and hip fractures were similar in both groups.

Compared with placebo, omega-3 fatty acid supplements had no significant effect on risk of total fractures (hazard ratio, 1.02; 95% confidence interval, 0.92-1.13), nonvertebral fractures (HR, 1.01; 95% CI, 0.91-1.12), or hip fractures (HR, 0.89; 95% CI, 0.61-1.30), all adjusted for age, sex, and race.

The “confidence intervals were narrow, likely excluding a clinically meaningful effect,” Dr. LeBoff noted.

Among men, those who received fish oil supplements had a greater risk of fracture than those who received placebo (HR, 1.27; 95% CI, 1.07-1.51), but this result “was not corrected for multiple hypothesis testing,” Dr. LeBoff cautioned.

In the overall population, participants with a BMI less than 25 who received fish oil versus placebo had an increased risk of fracture, and those with a BMI of at least 30 who received fish oil versus placebo had a decreased risk of fracture, but the limits of the confidence intervals crossed 1.00.

After excluding digit, skull, and pathologic fractures, there was no significant reduction in total fractures (HR, 1.02; 95% CI, 0.92-1.14), nonvertebral fractures (HR, 1.02; 95% CI, 0.92-1.14), or hip fractures (HR, 0.90; 95% CI, 0.61-1.33), with omega-3 supplements versus placebo.

Similarly, there was no significant reduction in risk of major osteoporotic fractures (hip, wrist, humerus, and clinical spine fractures) or wrist fractures with omega-3 supplements versus placebo.

VITAL only studied one dose of omega-3 fatty acid supplements, and results may not be generalizable to younger adults, or older adults living in residential communities, Dr. LeBoff noted.

The study was supported by grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. VITAL was funded by the National Cancer Institute and the National Heart, Lung, and Blood Institute. Dr. LeBoff and Dr. Langdahl have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The annual incidence of hip fractures declined in most countries from 2005 to 2018, but this rate is projected to roughly double by 2050, according to a new study of 19 countries/regions.

The study by Chor-Wing Sing, PhD, and colleagues was presented at the annual meeting of the American Society of Bone and Mineral Research. The predicted increase in hip fractures is being driven by the aging population, with the population of those age 85 and older projected to increase 4.5-fold from 2010 to 2050, they note.

The researchers also estimate that from 2018 to 2050 the incidence of fractures will increase by 1.9-fold overall – more in men (2.4-fold) than in women (1.7-fold).

In addition, rates of use of osteoporosis drugs 1 year after a hip fracture were less than 50%, with less treatment in men. Men were also more likely than women to die within 1 year of a hip fracture.

iStock/Thinkstock

Aging will fuel rise in hip fractures; more preventive treatment needed

“Even though there is a decreasing trend of hip fracture incidence in some countries, such a percentage decrease is insufficient to offset the percentage increase in the aging population,” senior co-author Ching-Lung Cheung, PhD, associate professor in the department of pharmacology and pharmacy at the University of Hong Kong, explained to this news organization.

The takeaways from the study are that “a greater effort on fracture prevention should be made to avoid the continuous increase in the number of hip fractures,” he said.

In addition, “although initiation of anti-osteoporosis medication after hip fracture is recommended in international guidelines, the 1-year treatment rate [was] well below 50% in most of the countries and regions studied. This indicates the treatment rate is far from optimal.”

“Our study also showed that the use of anti-osteoporosis medications following a hip fracture is lower in men than in women by 30% to 67%,” he said. “Thus, more attention should be paid to preventing and treating hip fractures in men.”

“The greater increase in the projected number of hip fractures in men than in women “could be [because] osteoporosis is commonly perceived as a ‘woman’s disease,’ ” he speculated.

Invited to comment, Juliet Compston, MD, who selected the study as one of the top clinical science highlight abstracts at the ASBMR meeting, agrees that “there is substantial room for improvement” in osteoporosis treatment rates following a hip fracture “in all the regions covered by the study.”

“In addition,” she continues, “the wide variations in treatment rates can provide important lessons about the most effective models of care for people who sustain a hip fracture: for example, fracture liaison services.”

Men suffer as osteoporosis perceived to be a ‘woman’s disease’

The even lower treatment rate in men than women is “concerning and likely reflects the mistaken perception that osteoporosis is predominantly a disease affecting women,” notes Dr. Compston, emeritus professor of bone medicine, University of Cambridge, United Kingdom.  

Also invited to comment, Peter R. Ebeling, MD, outgoing president of the ASBMR, said that the projected doubling of hip fractures “is likely mainly due to aging of the population, with increasing lifespan for males in particular. However, increasing urbanization and decreasing weight-bearing exercise as a result are likely to also contribute in developing countries.”

“Unfortunately, despite the advances in treatments for osteoporosis over the last 25 years, osteoporosis treatment rates remain low, and osteoporosis remains undiagnosed in postmenopausal women and older men,” added Dr. Ebeling, from Monash University, Melbourne, who was not involved with the research.

“More targeted screening for osteoporosis would help,” he said, “as would treating patients for it following other minimal trauma fractures (vertebral, distal radius, and humerus, etc.), since if left untreated, about 50% of these patients will have hip fractures later in life.”

“Some countries may be doing better because they have health quality standards for hip fracture (for example, surgery within 24 hours, investigation, and treatment for osteoporosis). In other countries like Australia, bone density tests and treatment for osteoporosis are reimbursed, increasing their uptake.”

The public health implications of this study are “substantial” according to Dr. Compston. “People who have sustained a hip fracture are at high risk of subsequent fractures if untreated. There is a range of safe, cost-effective pharmacological therapies to reduce fracture rate, and wider use of these would have a major impact on the current and future burden imposed by hip fractures in the elderly population.”

Similarly, Dr. Ebeling noted that “prevention is important to save a huge health burden for patients and costs for society.”

“Patients with minimal trauma fractures (particularly hip or spinal fractures) should be investigated and treated for osteoporosis with care pathways established in the hospitals, reaching out to the community [fracture liaison services],” he said.

Support for these is being sought under Medicare in the United States, he noted, and bone densitometry reimbursement rates also need to be higher in the United States.
 

Projections for number of hip fractures to 2050

Previous international reviews of hip fractures have been based on heterogeneous data from more than 10 to 30 years ago, the researchers note.

They performed a retrospective cohort study using a common protocol across 19 countries/regions, as described in an article about the protocol published in BMJ Open.

They analyzed data from adults aged 50 and older who were hospitalized with a hip fracture to determine 1) the annual incidence of hip fractures in 2008-2015; 2) the uptake of drugs to treat osteoporosis at 1 year after a hip fracture; and 3) all-cause mortality at 1 year after a hip fracture.

In a second step, they estimated the number of hip fractures that would occur from 2030 to 2050, using World Bank population growth projections.

The data are from 20 health care databases from 19 countries/regions: Oceania (Australia, New Zealand), Asia (Hong Kong, Japan, Singapore, South Korea, Taiwan, and Thailand), Northern Europe (Denmark, Finland, and U.K.), Western Europe (France, Germany, Italy, The Netherlands, and Spain), and North and South America (Canada, United States, and Brazil).

The population in Japan was under age 75. U.S. data are from two databases: Medicare (age ≥ 65) and Optum.

Most databases (13) covered 90%-100% of the national population, and the rest covered 5%-70% of the population.

From 2008 to 2015, the annual incidence of hip fractures declined in 11 countries/regions (Singapore, Denmark, Hong Kong, Taiwan, Finland, U.K., Italy, Spain, United States [Medicare], Canada, and New Zealand).

“One potential reason that some countries have seen relatively large declines in hip fractures is better osteoporosis management and post-fracture care,” said Dr. Sing in a press release issued by ASBMR. “Better fall-prevention programs and clearer guidelines for clinical care have likely made a difference.”

Hip fracture incidence increased in five countries (The Netherlands, South Korea, France, Germany, and Brazil) and was stable in four countries (Australia, Japan, Thailand, and United States [Optum]).

The United Kingdom had the highest rate of osteoporosis treatment at 1-year after a hip fracture (50.3%). Rates in the other countries/regions ranged from 11.5% to 37%.

Fewer men than women were receiving drugs for osteoporosis at 1 year (range 5.1% to 38.2% versus 15.0% to 54.7%).

From 2005 to 2018, rates of osteoporosis treatment at 1 year after a hip fracture declined in six countries, increased in four countries, and were stable in five countries.

All-cause mortality within 1 year of hip fracture was higher in men than in women (range 19.2% to 35.8% versus 12.1% to 25.4%).

“Among the studied countries and regions, the U.S. ranks fifth with the highest hip fracture incidence,” Dr. Cheung replied when specifically asked about this. “The risk of hip fracture is determined by multiple factors: for example, lifestyle, diet, genetics, as well as management of osteoporosis,” he noted.

“Denmark is the only country showing no projected increase, and it is because Denmark had a continuous and remarkable decrease in the incidence of hip fractures,” he added, which “can offset the number of hip fractures contributed by the population aging.”

The study was funded by Amgen. Dr. Sing and Dr. Cheung have reported no relevant financial relationships. One of the study authors is employed by Amgen.

A version of this article first appeared on Medscape.com.

The annual incidence of hip fractures declined in most countries from 2005 to 2018, but this rate is projected to roughly double by 2050, according to a new study of 19 countries/regions.

The study by Chor-Wing Sing, PhD, and colleagues was presented at the annual meeting of the American Society of Bone and Mineral Research. The predicted increase in hip fractures is being driven by the aging population, with the population of those age 85 and older projected to increase 4.5-fold from 2010 to 2050, they note.

The researchers also estimate that from 2018 to 2050 the incidence of fractures will increase by 1.9-fold overall – more in men (2.4-fold) than in women (1.7-fold).

In addition, rates of use of osteoporosis drugs 1 year after a hip fracture were less than 50%, with less treatment in men. Men were also more likely than women to die within 1 year of a hip fracture.

iStock/Thinkstock

Aging will fuel rise in hip fractures; more preventive treatment needed

“Even though there is a decreasing trend of hip fracture incidence in some countries, such a percentage decrease is insufficient to offset the percentage increase in the aging population,” senior co-author Ching-Lung Cheung, PhD, associate professor in the department of pharmacology and pharmacy at the University of Hong Kong, explained to this news organization.

The takeaways from the study are that “a greater effort on fracture prevention should be made to avoid the continuous increase in the number of hip fractures,” he said.

In addition, “although initiation of anti-osteoporosis medication after hip fracture is recommended in international guidelines, the 1-year treatment rate [was] well below 50% in most of the countries and regions studied. This indicates the treatment rate is far from optimal.”

“Our study also showed that the use of anti-osteoporosis medications following a hip fracture is lower in men than in women by 30% to 67%,” he said. “Thus, more attention should be paid to preventing and treating hip fractures in men.”

“The greater increase in the projected number of hip fractures in men than in women “could be [because] osteoporosis is commonly perceived as a ‘woman’s disease,’ ” he speculated.

Invited to comment, Juliet Compston, MD, who selected the study as one of the top clinical science highlight abstracts at the ASBMR meeting, agrees that “there is substantial room for improvement” in osteoporosis treatment rates following a hip fracture “in all the regions covered by the study.”

“In addition,” she continues, “the wide variations in treatment rates can provide important lessons about the most effective models of care for people who sustain a hip fracture: for example, fracture liaison services.”

Men suffer as osteoporosis perceived to be a ‘woman’s disease’

The even lower treatment rate in men than women is “concerning and likely reflects the mistaken perception that osteoporosis is predominantly a disease affecting women,” notes Dr. Compston, emeritus professor of bone medicine, University of Cambridge, United Kingdom.  

Also invited to comment, Peter R. Ebeling, MD, outgoing president of the ASBMR, said that the projected doubling of hip fractures “is likely mainly due to aging of the population, with increasing lifespan for males in particular. However, increasing urbanization and decreasing weight-bearing exercise as a result are likely to also contribute in developing countries.”

“Unfortunately, despite the advances in treatments for osteoporosis over the last 25 years, osteoporosis treatment rates remain low, and osteoporosis remains undiagnosed in postmenopausal women and older men,” added Dr. Ebeling, from Monash University, Melbourne, who was not involved with the research.

“More targeted screening for osteoporosis would help,” he said, “as would treating patients for it following other minimal trauma fractures (vertebral, distal radius, and humerus, etc.), since if left untreated, about 50% of these patients will have hip fractures later in life.”

“Some countries may be doing better because they have health quality standards for hip fracture (for example, surgery within 24 hours, investigation, and treatment for osteoporosis). In other countries like Australia, bone density tests and treatment for osteoporosis are reimbursed, increasing their uptake.”

The public health implications of this study are “substantial” according to Dr. Compston. “People who have sustained a hip fracture are at high risk of subsequent fractures if untreated. There is a range of safe, cost-effective pharmacological therapies to reduce fracture rate, and wider use of these would have a major impact on the current and future burden imposed by hip fractures in the elderly population.”

Similarly, Dr. Ebeling noted that “prevention is important to save a huge health burden for patients and costs for society.”

“Patients with minimal trauma fractures (particularly hip or spinal fractures) should be investigated and treated for osteoporosis with care pathways established in the hospitals, reaching out to the community [fracture liaison services],” he said.

Support for these is being sought under Medicare in the United States, he noted, and bone densitometry reimbursement rates also need to be higher in the United States.
 

Projections for number of hip fractures to 2050

Previous international reviews of hip fractures have been based on heterogeneous data from more than 10 to 30 years ago, the researchers note.

They performed a retrospective cohort study using a common protocol across 19 countries/regions, as described in an article about the protocol published in BMJ Open.

They analyzed data from adults aged 50 and older who were hospitalized with a hip fracture to determine 1) the annual incidence of hip fractures in 2008-2015; 2) the uptake of drugs to treat osteoporosis at 1 year after a hip fracture; and 3) all-cause mortality at 1 year after a hip fracture.

In a second step, they estimated the number of hip fractures that would occur from 2030 to 2050, using World Bank population growth projections.

The data are from 20 health care databases from 19 countries/regions: Oceania (Australia, New Zealand), Asia (Hong Kong, Japan, Singapore, South Korea, Taiwan, and Thailand), Northern Europe (Denmark, Finland, and U.K.), Western Europe (France, Germany, Italy, The Netherlands, and Spain), and North and South America (Canada, United States, and Brazil).

The population in Japan was under age 75. U.S. data are from two databases: Medicare (age ≥ 65) and Optum.

Most databases (13) covered 90%-100% of the national population, and the rest covered 5%-70% of the population.

From 2008 to 2015, the annual incidence of hip fractures declined in 11 countries/regions (Singapore, Denmark, Hong Kong, Taiwan, Finland, U.K., Italy, Spain, United States [Medicare], Canada, and New Zealand).

“One potential reason that some countries have seen relatively large declines in hip fractures is better osteoporosis management and post-fracture care,” said Dr. Sing in a press release issued by ASBMR. “Better fall-prevention programs and clearer guidelines for clinical care have likely made a difference.”

Hip fracture incidence increased in five countries (The Netherlands, South Korea, France, Germany, and Brazil) and was stable in four countries (Australia, Japan, Thailand, and United States [Optum]).

The United Kingdom had the highest rate of osteoporosis treatment at 1-year after a hip fracture (50.3%). Rates in the other countries/regions ranged from 11.5% to 37%.

Fewer men than women were receiving drugs for osteoporosis at 1 year (range 5.1% to 38.2% versus 15.0% to 54.7%).

From 2005 to 2018, rates of osteoporosis treatment at 1 year after a hip fracture declined in six countries, increased in four countries, and were stable in five countries.

All-cause mortality within 1 year of hip fracture was higher in men than in women (range 19.2% to 35.8% versus 12.1% to 25.4%).

“Among the studied countries and regions, the U.S. ranks fifth with the highest hip fracture incidence,” Dr. Cheung replied when specifically asked about this. “The risk of hip fracture is determined by multiple factors: for example, lifestyle, diet, genetics, as well as management of osteoporosis,” he noted.

“Denmark is the only country showing no projected increase, and it is because Denmark had a continuous and remarkable decrease in the incidence of hip fractures,” he added, which “can offset the number of hip fractures contributed by the population aging.”

The study was funded by Amgen. Dr. Sing and Dr. Cheung have reported no relevant financial relationships. One of the study authors is employed by Amgen.

A version of this article first appeared on Medscape.com.

The annual incidence of hip fractures declined in most countries from 2005 to 2018, but this rate is projected to roughly double by 2050, according to a new study of 19 countries/regions.

The study by Chor-Wing Sing, PhD, and colleagues was presented at the annual meeting of the American Society of Bone and Mineral Research. The predicted increase in hip fractures is being driven by the aging population, with the population of those age 85 and older projected to increase 4.5-fold from 2010 to 2050, they note.

The researchers also estimate that from 2018 to 2050 the incidence of fractures will increase by 1.9-fold overall – more in men (2.4-fold) than in women (1.7-fold).

In addition, rates of use of osteoporosis drugs 1 year after a hip fracture were less than 50%, with less treatment in men. Men were also more likely than women to die within 1 year of a hip fracture.

iStock/Thinkstock

Aging will fuel rise in hip fractures; more preventive treatment needed

“Even though there is a decreasing trend of hip fracture incidence in some countries, such a percentage decrease is insufficient to offset the percentage increase in the aging population,” senior co-author Ching-Lung Cheung, PhD, associate professor in the department of pharmacology and pharmacy at the University of Hong Kong, explained to this news organization.

The takeaways from the study are that “a greater effort on fracture prevention should be made to avoid the continuous increase in the number of hip fractures,” he said.

In addition, “although initiation of anti-osteoporosis medication after hip fracture is recommended in international guidelines, the 1-year treatment rate [was] well below 50% in most of the countries and regions studied. This indicates the treatment rate is far from optimal.”

“Our study also showed that the use of anti-osteoporosis medications following a hip fracture is lower in men than in women by 30% to 67%,” he said. “Thus, more attention should be paid to preventing and treating hip fractures in men.”

“The greater increase in the projected number of hip fractures in men than in women “could be [because] osteoporosis is commonly perceived as a ‘woman’s disease,’ ” he speculated.

Invited to comment, Juliet Compston, MD, who selected the study as one of the top clinical science highlight abstracts at the ASBMR meeting, agrees that “there is substantial room for improvement” in osteoporosis treatment rates following a hip fracture “in all the regions covered by the study.”

“In addition,” she continues, “the wide variations in treatment rates can provide important lessons about the most effective models of care for people who sustain a hip fracture: for example, fracture liaison services.”

Men suffer as osteoporosis perceived to be a ‘woman’s disease’

The even lower treatment rate in men than women is “concerning and likely reflects the mistaken perception that osteoporosis is predominantly a disease affecting women,” notes Dr. Compston, emeritus professor of bone medicine, University of Cambridge, United Kingdom.  

Also invited to comment, Peter R. Ebeling, MD, outgoing president of the ASBMR, said that the projected doubling of hip fractures “is likely mainly due to aging of the population, with increasing lifespan for males in particular. However, increasing urbanization and decreasing weight-bearing exercise as a result are likely to also contribute in developing countries.”

“Unfortunately, despite the advances in treatments for osteoporosis over the last 25 years, osteoporosis treatment rates remain low, and osteoporosis remains undiagnosed in postmenopausal women and older men,” added Dr. Ebeling, from Monash University, Melbourne, who was not involved with the research.

“More targeted screening for osteoporosis would help,” he said, “as would treating patients for it following other minimal trauma fractures (vertebral, distal radius, and humerus, etc.), since if left untreated, about 50% of these patients will have hip fractures later in life.”

“Some countries may be doing better because they have health quality standards for hip fracture (for example, surgery within 24 hours, investigation, and treatment for osteoporosis). In other countries like Australia, bone density tests and treatment for osteoporosis are reimbursed, increasing their uptake.”

The public health implications of this study are “substantial” according to Dr. Compston. “People who have sustained a hip fracture are at high risk of subsequent fractures if untreated. There is a range of safe, cost-effective pharmacological therapies to reduce fracture rate, and wider use of these would have a major impact on the current and future burden imposed by hip fractures in the elderly population.”

Similarly, Dr. Ebeling noted that “prevention is important to save a huge health burden for patients and costs for society.”

“Patients with minimal trauma fractures (particularly hip or spinal fractures) should be investigated and treated for osteoporosis with care pathways established in the hospitals, reaching out to the community [fracture liaison services],” he said.

Support for these is being sought under Medicare in the United States, he noted, and bone densitometry reimbursement rates also need to be higher in the United States.
 

Projections for number of hip fractures to 2050

Previous international reviews of hip fractures have been based on heterogeneous data from more than 10 to 30 years ago, the researchers note.

They performed a retrospective cohort study using a common protocol across 19 countries/regions, as described in an article about the protocol published in BMJ Open.

They analyzed data from adults aged 50 and older who were hospitalized with a hip fracture to determine 1) the annual incidence of hip fractures in 2008-2015; 2) the uptake of drugs to treat osteoporosis at 1 year after a hip fracture; and 3) all-cause mortality at 1 year after a hip fracture.

In a second step, they estimated the number of hip fractures that would occur from 2030 to 2050, using World Bank population growth projections.

The data are from 20 health care databases from 19 countries/regions: Oceania (Australia, New Zealand), Asia (Hong Kong, Japan, Singapore, South Korea, Taiwan, and Thailand), Northern Europe (Denmark, Finland, and U.K.), Western Europe (France, Germany, Italy, The Netherlands, and Spain), and North and South America (Canada, United States, and Brazil).

The population in Japan was under age 75. U.S. data are from two databases: Medicare (age ≥ 65) and Optum.

Most databases (13) covered 90%-100% of the national population, and the rest covered 5%-70% of the population.

From 2008 to 2015, the annual incidence of hip fractures declined in 11 countries/regions (Singapore, Denmark, Hong Kong, Taiwan, Finland, U.K., Italy, Spain, United States [Medicare], Canada, and New Zealand).

“One potential reason that some countries have seen relatively large declines in hip fractures is better osteoporosis management and post-fracture care,” said Dr. Sing in a press release issued by ASBMR. “Better fall-prevention programs and clearer guidelines for clinical care have likely made a difference.”

Hip fracture incidence increased in five countries (The Netherlands, South Korea, France, Germany, and Brazil) and was stable in four countries (Australia, Japan, Thailand, and United States [Optum]).

The United Kingdom had the highest rate of osteoporosis treatment at 1-year after a hip fracture (50.3%). Rates in the other countries/regions ranged from 11.5% to 37%.

Fewer men than women were receiving drugs for osteoporosis at 1 year (range 5.1% to 38.2% versus 15.0% to 54.7%).

From 2005 to 2018, rates of osteoporosis treatment at 1 year after a hip fracture declined in six countries, increased in four countries, and were stable in five countries.

All-cause mortality within 1 year of hip fracture was higher in men than in women (range 19.2% to 35.8% versus 12.1% to 25.4%).

“Among the studied countries and regions, the U.S. ranks fifth with the highest hip fracture incidence,” Dr. Cheung replied when specifically asked about this. “The risk of hip fracture is determined by multiple factors: for example, lifestyle, diet, genetics, as well as management of osteoporosis,” he noted.

“Denmark is the only country showing no projected increase, and it is because Denmark had a continuous and remarkable decrease in the incidence of hip fractures,” he added, which “can offset the number of hip fractures contributed by the population aging.”

The study was funded by Amgen. Dr. Sing and Dr. Cheung have reported no relevant financial relationships. One of the study authors is employed by Amgen.

A version of this article first appeared on Medscape.com.