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Baveno VI Criteria Appear Cost-Effective for Detecting Varices in Cirrhosis
Compared with endoscopy, , according to new research.
Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.
“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.
“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.
The study was published online in Clinical Gastroenterology and Hepatology.
Baveno VI Criteria Analysis
On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa.
In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.
Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.
Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.
As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.
In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.
For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.
In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.
The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
Baveno VI Considerations
Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.
“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.
Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.
“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.
“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.
The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Compared with endoscopy, , according to new research.
Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.
“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.
“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.
The study was published online in Clinical Gastroenterology and Hepatology.
Baveno VI Criteria Analysis
On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa.
In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.
Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.
Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.
As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.
In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.
For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.
In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.
The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
Baveno VI Considerations
Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.
“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.
Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.
“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.
“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.
The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
Compared with endoscopy, , according to new research.
Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.
“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.
“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.
The study was published online in Clinical Gastroenterology and Hepatology.
Baveno VI Criteria Analysis
On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa.
In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.
Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.
Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.
As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.
In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.
For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.
In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.
The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
Baveno VI Considerations
Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.
“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.
Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.
“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.
“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.
The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
One in Five Overdose Deaths in 2022 had an Unrelated Mental Illness
TOPLINE:
In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.
METHODOLOGY:
- The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
- A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
- MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
- Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.
TAKEAWAY:
- In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
- Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
- Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
- About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.
IN PRACTICE:
“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.
SOURCE:
The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.
LIMITATIONS:
The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.
DISCLOSURES:
The study funding source was not reported. The authors did not disclose any conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.
METHODOLOGY:
- The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
- A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
- MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
- Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.
TAKEAWAY:
- In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
- Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
- Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
- About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.
IN PRACTICE:
“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.
SOURCE:
The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.
LIMITATIONS:
The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.
DISCLOSURES:
The study funding source was not reported. The authors did not disclose any conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.
METHODOLOGY:
- The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
- A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
- MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
- Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.
TAKEAWAY:
- In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
- Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
- Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
- About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.
IN PRACTICE:
“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.
SOURCE:
The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.
LIMITATIONS:
The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.
DISCLOSURES:
The study funding source was not reported. The authors did not disclose any conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
2025 Crohn’s & Colitis Congress® Abstract Submissions
The 2025 Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).
Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.
Presenting authors will receive notification of acceptance on Monday, Dec. 9.
The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.
Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.
The 2025 Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).
Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.
Presenting authors will receive notification of acceptance on Monday, Dec. 9.
The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.
Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.
The 2025 Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).
Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.
Presenting authors will receive notification of acceptance on Monday, Dec. 9.
The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.
Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.
‘Remarkable’ Weight Loss Seen With Safe, Tolerable Novel Oral Combination
MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.
Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”
With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.
The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
Dual Pathways
Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.
The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.
The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy.
Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks.
In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12).
The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints.
The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint.
Safety Findings of Multiple Dosing
A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity.
Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.
“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.
Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total).
Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.
Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
Body Weight Reduction
Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks.
Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.
To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.
In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”
The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.
Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”
But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.”
Oral Meds Could Bring Down Cost
Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.”
If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect.
“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].”
“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”
Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”
Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.
A version of this article first appeared on Medscape.com.
MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.
Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”
With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.
The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
Dual Pathways
Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.
The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.
The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy.
Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks.
In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12).
The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints.
The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint.
Safety Findings of Multiple Dosing
A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity.
Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.
“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.
Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total).
Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.
Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
Body Weight Reduction
Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks.
Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.
To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.
In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”
The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.
Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”
But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.”
Oral Meds Could Bring Down Cost
Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.”
If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect.
“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].”
“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”
Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”
Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.
A version of this article first appeared on Medscape.com.
MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.
Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”
With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.
The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
Dual Pathways
Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.
The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.
The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy.
Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks.
In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12).
The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints.
The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint.
Safety Findings of Multiple Dosing
A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity.
Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.
“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.
Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total).
Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.
Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
Body Weight Reduction
Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks.
Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.
To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.
In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”
The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.
Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”
But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.”
Oral Meds Could Bring Down Cost
Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.”
If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect.
“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].”
“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”
Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”
Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.
A version of this article first appeared on Medscape.com.
FROM EASD 2024
Montana Hospital to Pay $10.8M to Settle False Claims Oncology Suit
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.
On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”
“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.
On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
When It Began
The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims.
“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.
At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job.
Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.
Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.
Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause.
John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
$10.8 Million: ‘It’s a Big Number’
At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million.
The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020.
According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims.
The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.
“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.”
“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.”
The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement
Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020.
“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.
In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”
Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”
The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.”
The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.
The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025.
A Community’s Support
Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.
Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well.
Like other residents, she has strong opinions about the settlement.
“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”
Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members.
Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters.
“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.
A version of this article first appeared on Medscape.com.
FDA Investigates Tampons for Potential Lead and Metal Risks
The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.
The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.
“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”
There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.
The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.
The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.
There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.
The FDA plans a more expansive set of analyses than the earlier study, the agency announced.
“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”
The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.
Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.
The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.
The FDA announcement did not specify a timeframe for the completion of its investigation.
A version of this article first appeared on WebMD.
The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.
The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.
“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”
There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.
The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.
The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.
There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.
The FDA plans a more expansive set of analyses than the earlier study, the agency announced.
“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”
The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.
Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.
The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.
The FDA announcement did not specify a timeframe for the completion of its investigation.
A version of this article first appeared on WebMD.
The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.
The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.
“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”
There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.
The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.
The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.
There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.
The FDA plans a more expansive set of analyses than the earlier study, the agency announced.
“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”
The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.
Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.
The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.
The FDA announcement did not specify a timeframe for the completion of its investigation.
A version of this article first appeared on WebMD.
Could a Virus Reverse Antibiotic Resistance?
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Peering through his microscope in 1910, Franco-Canadian microbiologist Félix d’Hérelle noticed some “clear spots” in his bacterial cultures, an anomaly that turned out to be viruses preying on the bacteria. Years later, Mr. d’Hérelle would come to use these viruses, which he called bacteriophages, to treat patients plagued with dysentery after World War I.
But now, with bacteria evolving resistance to more and more antibiotics, phage therapy is drawing a second look from researchers — sometimes with a novel twist. Instead of simply using the phages to kill bacteria directly, the new strategy aims to catch the bacteria in an evolutionary dilemma — one in which they cannot evade phages and antibiotics simultaneously.
This plan, which uses something called “phage steering,” has shown promising results in initial tests, but the scope of its usefulness remains to be proven.
There’s certainly need to find new ways to respond to bacterial infections. More than 70% of hospital-acquired bacterial infections in the United States are resistant to at least one type of antibiotic. And some pathogens, such as Acinetobacter, Pseudomonas, Escherichia coli, and Klebsiella — classified by the World Health Organization as some of the biggest threats to human health — are resistant to multiple antibiotics. In 2019, antibacterial resistance was linked to 4.95 million deaths globally, heightening the call for more effective treatment options.
One of the ways that bacteria can evolve resistance to antibiotics is by using structures in their membranes that are designed to move unwanted molecules out of the cell. By modifying these “efflux pumps” to recognize the antibiotic, bacteria can eliminate the drug before it poisons them.
As it turns out, some phages appear to use these same efflux pumps to invade the bacterial cell. The phage presumably attaches its tail to the outer portion of the pump protein, like a key slipping into a lock, and then injects its genetic material into the cell. This lucky coincidence led Paul Turner, PhD, an evolutionary biologist at Yale University, New Haven, Connecticut, to suggest that treating a patient with phages and antibiotics simultaneously could trap bacteria in a no-win situation: If they evolve to modify their efflux pumps so the phage can’t bind, the pumps will no longer expel antibiotics, and the bacteria will lose their resistance. But if they retain their antibiotic resistance, the phages will kill them, as Dr. Turner and colleagues explained in the 2023 Annual Review of Virology.
The result, in other words, is a two-pronged attack, said Michael Hochberg, PhD, an evolutionary biologist at the French National Centre for Scientific Research who studies how to prevent the evolution of bacterial resistance. “It’s kind of like a crisscross effect.” The same principle can target other bacterial molecules that play a dual role in resistance to viruses and antibiotics.
Turner tested this hypothesis on multidrug-resistant Pseudomonas aeruginosa, which causes dangerous infections, especially in healthcare settings. This bacterium has four efflux pumps involved in antibiotic resistance, and Dr. Turner predicted that if he could find a phage that used one of the pumps as a way into the cell, the bacterium would be forced to slam the door on the phage by mutating the receptor — thereby impeding its ability to pump out antibiotics.
Sampling from the environment, Dr. Turner’s team collected 42 phage strains that infect P aeruginosa. Out of all the phages, one, OMKO1, bound to an efflux pump, making it the perfect candidate for the experiment.
The researchers then cultured antibiotic-resistant P aeruginosa together with OMKO1, hoping this would force the bacterium to modify its efflux pump to resist the phage. They exposed these phage-resistant bacteria, as well as their normal, phage-sensitive counterparts, to four antibiotics the bacteria had been resistant to: tetracycline, erythromycin, ciprofloxacin, and ceftazidime.
As the theory predicted, the bacteria that had evolved resistance to the phage were more sensitive to the antibiotics than those that had not been exposed to the phage. This suggests that the bacteria had, indeed, been forced to lose their antibiotic resistance through their need to fight off the phage.
Other researchers have also shown that phage steering can resensitize bacteria to common antibiotics they’d become resistant to. One study, by an international research team, showed that a phage called Phab24 can be used to restore sensitivity to the antibiotic colistin in Acinetobacter baumannii, which causes life-threatening diseases.
In a second study, researchers at Monash University in Australia sampled infectious bacteria from patients. They found that several phages, including strains known as phi-FG02 and phi-CO01, were already present in some of the samples, and that A baumannii bacteria exposed to the phages had inactivated a gene that helps create the microbe’s important outer layer, or capsule. This layer serves as the entry point for the phages, but it also helps the bacterium to form biofilms that keep out antibiotics — so removing the layer rendered A baumannii susceptible to several antibiotics that it was previously resistant to.
In a third study, researchers from the University of Liverpool discovered that, when a P aeruginosa strain that was resistant to all antibiotics was exposed to phages, the bacterium became sensitive to two antibiotics that were otherwise considered ineffective against P aeruginosa.
Dr. Turner’s team has used phage steering in dozens of cases of personalized therapy in clinical settings, said Benjamin Chan, PhD, a microbiologist at Yale University who works with Dr. Turner. The results, many still unpublished, have been promising so far. Nonrespiratory infections are relatively easy to clear off, and lung infections, which the phage steering approach wouldn’t be expected to eradicate completely, often show some improvement.
“I would say that we have been quite successful in using phage steering to treat difficult-to-manage infections, reducing antimicrobial resistance in many cases,” he said. But he notes that it is sometimes difficult to determine whether phage steering really was responsible for the cures.
Devil in the details
Phage therapy may not work for all antibiotic-resistant bacteria, said molecular biologist Graham Hatfull, PhD, of the University of Pittsburgh in Pennsylvania. That’s because phages are very host specific, and for most phages, no one knows what target they bind to on the bacterial cell surface. For phage steering to work against antibiotic resistance, the phage has to bind to a molecule that’s involved in that resistance — and it’s not clear how often that fortuitous coincidence occurs.
Jason Gill, PhD, who studies bacteriophage biology at Texas A&M University, College Station, said that it is not easy to predict if a phage will induce antibiotic sensitivity. So you always have to hunt for the right virus each time.
Dr. Gill knows from experience how complicated the approach can get. He was part of a team of researchers and doctors who used phages to treat a patient with a multidrug-resistant A baumannii infection. Less than 4 days after the team administered phages intravenously and through the skin, the patient woke up from a coma and became responsive to the previously ineffective antibiotic minocycline — a striking success.
But when Dr. Gill tried a similar experiment in cell cultures, he got a different result. The A baumannii developed resistance to the phages, but they also maintained their resistance to minocycline. “There’s not a complete mechanistic understanding,” said Dr. Gill. “The linkage between phage resistance and antibiotic sensitivity probably varies by bacterial strain, phage and antibiotic.” That means phage steering may not always work.
Dr. Turner, for his part, pointed out another potential problem: That phages could work too well. If phage therapy kills large amounts of bacteria and deposits their remains in the bloodstream quickly, for example, this could trigger septic shock in patients. Scientists do not yet know how to address this problem.
Another concern is that doctors have less precise control over phages than antibiotics. “Phages can mutate, they can adapt, they have a genome,” said Dr. Hochberg. Safety concerns, he notes, are one factor inhibiting the routine use of phage therapy in countries like the United States, restricting it to case-by-case applications such as Dr. Turner and Dr. Chan’s.
Phage therapy may have been too high-tech for the 1940s, and even today, scientists grapple with how to use it. What we need now, said Dr. Turner, are rigorous experiments that will teach us how to make it work.
This article originally appeared in Knowable Magazine on September 09, 2024. Knowable Magazine is an independent journalistic endeavor from Annual Reviews, a nonprofit publisher dedicated to synthesizing and integrating knowledge for the progress of science and the benefit of society. Sign up for Knowable Magazine’s newsletter. A version of this article appeared on Medscape.com.
Genitourinary Symptoms in Men: Canaries in the Coal Mine for Underlying Chronic Disease
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.
At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.
While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.
Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.
“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.
That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.
In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.
In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.
This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.
As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
Ask Early, Ask Often
Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.
It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.
Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:
- Are you having trouble with erections or having sex?
- Are you getting up at night to pass urine more than once?
“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”
Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”
Addressing the Issue
Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.
Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”
“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.
Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.
Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
A version of this article appeared on Medscape.com.
Early vs Late Fast Window: Is One More Effective?
MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.
The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.
“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”
The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”
The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.
Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.
But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.
“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
Three-Day TRE Plan Led to Blood Glucose Control
In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m2, had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.
“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.
Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.
Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.
There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m2, and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.
Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.
No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.
Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”
Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.
“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.
She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.
“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.
Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”
Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.
Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.
A version of this article first appeared on Medscape.com.
MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.
The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.
“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”
The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”
The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.
Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.
But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.
“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
Three-Day TRE Plan Led to Blood Glucose Control
In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m2, had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.
“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.
Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.
Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.
There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m2, and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.
Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.
No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.
Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”
Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.
“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.
She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.
“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.
Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”
Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.
Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.
A version of this article first appeared on Medscape.com.
MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.
The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.
“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”
The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”
The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.
Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.
But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.
“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
Three-Day TRE Plan Led to Blood Glucose Control
In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m2, had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.
“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.
Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.
Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.
There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m2, and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.
Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.
No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.
Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”
Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.
“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.
She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.
“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.
Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”
Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.
Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM EASD 2024
Can AI Improve Cardiomyopathy Detection in Pregnant Women?
TOPLINE:
Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.
METHODOLOGY:
- Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
- Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
- The primary outcome was the identification of LVSD confirmed by echocardiography.
- Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.
TAKEAWAY:
- AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
- The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
- No serious adverse events related to study participation were reported.
- The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.
IN PRACTICE:
“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
SOURCE:
This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.
LIMITATIONS:
The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.
DISCLOSURES:
Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.
METHODOLOGY:
- Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
- Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
- The primary outcome was the identification of LVSD confirmed by echocardiography.
- Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.
TAKEAWAY:
- AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
- The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
- No serious adverse events related to study participation were reported.
- The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.
IN PRACTICE:
“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
SOURCE:
This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.
LIMITATIONS:
The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.
DISCLOSURES:
Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.
METHODOLOGY:
- Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
- Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
- The primary outcome was the identification of LVSD confirmed by echocardiography.
- Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.
TAKEAWAY:
- AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
- The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
- No serious adverse events related to study participation were reported.
- The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.
IN PRACTICE:
“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
SOURCE:
This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.
LIMITATIONS:
The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.
DISCLOSURES:
Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.