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‘Alarming’ increase in fake pills laced with fentanyl, methamphetamine, DEA warns
The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.
“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.
“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.
Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.
such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).
The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.
The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.
These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.
More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.
The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.
This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.
“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.
A version of this article first appeared on Medscape.com.
The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.
“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.
“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.
Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.
such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).
The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.
The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.
These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.
More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.
The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.
This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.
“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.
A version of this article first appeared on Medscape.com.
The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.
“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.
“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.
Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.
such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).
The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.
The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.
These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.
More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.
The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.
This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.
“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.
A version of this article first appeared on Medscape.com.
Heart failure hospitalization risk lower with SGLT2 inhibitors than GLP-1 RAs
Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.
The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.
“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.
They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.
Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.
Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”
Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
Addressing the knowledge gap
Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.
To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).
One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.
Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).
The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
Real-world studies are of ‘increasing value’
“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”
Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.
“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”
Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”
The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.
Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.
Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.
The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.
“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.
They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.
Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.
Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”
Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
Addressing the knowledge gap
Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.
To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).
One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.
Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).
The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
Real-world studies are of ‘increasing value’
“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”
Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.
“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”
Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”
The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.
Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.
Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.
The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.
“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.
They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.
Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.
Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”
Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
Addressing the knowledge gap
Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.
To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).
One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.
Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).
The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
Real-world studies are of ‘increasing value’
“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”
Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.
“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”
Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”
The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.
Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.
FROM ANNALS OF INTERNAL MEDICINE
Physical activity paradoxically tied to higher coronary calcium
new observational data suggest.
In a prospective cohort study of Korean men and women 18 years and older, participants who were the most physically active had the fastest progression of their coronary artery calcium (CAC) scores at 5 years, compared with those who were the least physically active.
“People who exercise may have an increase in their coronary calcium levels, but this is not necessarily bad news. This may mean that atherosclerotic lesions in the coronary arteries are becoming more stable and less dangerous, but we need additional research to understand these changes,” Eliseo Guallar, MD, PhD, professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, the study’s corresponding author, said in an interview.
This paradoxical effect notwithstanding, doctors should continue to advise their patients to follow the physical activity guidelines for Americans that were published in 2018, Dr. Guallar said.
“Physical activity is a key component of a healthy lifestyle. Our analysis can be useful, however, if someone starts exercising and sees that his or her coronary calcium score goes up,” he said.
The study is published online September 20 in Heart.
The degree of build-up of calcium deposits in the coronary arteries is used to determine future cardiovascular disease risk and to guide treatment to prevent myocardial infarction and stroke. A CAC score of at least 100 Agatston units indicates that treatment with statins is warranted, the researchers write.
In the current study, investigators — led by Ki-Chul Sung, MD, Sungkyunkwan University School of Medicine, Seoul, Korea, and Yun Soo Hong, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore — explored the link between different degrees of physical activity and the progression of CAC scores in healthy adults.
“While physical activity improves a wide array of cardiovascular and metabolic biomarkers, endurance athletes were more likely to have a coronary artery calcium (CAC) score >300 Agatston units or coronary plaques compared with sedentary men with a similar risk profile. It is not clear if exercise may itself be associated with calcification of the arteries,” the authors write.
The researchers studied 25,485 participants (22,741 men and 2,744 women) who were part of the Kangbuk Samsung Health Study. All were free of cardiovascular disease at study entry and underwent comprehensive health screening exams at one of two major health centers in Seoul and Suwon, South Korea, between March 1, 2011, and December 31, 2017.
At each exam, participants filled out a questionnaire that included questions on medical and family history, smoking habits, alcohol intake, and education level.
Participants were also quizzed at baseline about their physical activity, using the Korean version of the International Physical Activity Questionnaire Short Form (IPAQ-SF).
On the basis of that, they were categorized into one of three categories: inactive; moderately active, defined as at least 3 days of vigorous-intensity activity for at least 20 min/day or at least 5 days of moderate-intensity activity or walking for at least 30 min/ day or at least 5 days of any combination of walking and moderate- or vigorous-intensity activities, attaining at least 600 MET-min/week; or health-enhancing physically active (HEPA), defined as at least 3 days of vigorous-intensity activity, attaining at least 1,500 MET-min/week or 7 days of any combination of walking or moderate- or vigorous-intensity activities, attaining at least 3000 MET-min/week.
Of the study participants, 47% were classified as inactive, 38% as moderately active, and 15% as HEPA.
Those who were more physically active tended to be older and less likely to smoke than less physically active participants. They also had lower total cholesterol, more hypertension, and existing evidence of calcium deposits in their coronary arteries.
A graded association between physical activity level and the prevalence and progression of coronary artery calcification was seen, irrespective of CAC scores at the start of monitoring.
At baseline, the estimated adjusted average baseline CAC scores in inactive participants was 9.45 (95% CI, 8.76 - 10.14), in moderately active participants was 10.20 (95% CI, 9.40 - 11.00), and in HEPA participants was 12.04 (95% CI, 10.81 - 13.26).
Compared with the least active participants, the estimated adjusted 5-year average increases in CAC was 3.20 (95% CI, 0.72 - 5.69) in moderately active participants and 8.16 (95% CI, 4.80 - 11.53) in HEPA participants.
A higher level of physical activity was associated with faster progression of CAC scores, both in participants with CAC score of 0 at baseline and in those with prevalent CAC.
The authors note there are several limitations to consider when interpreting their findings. These include the absence of an objective assessment of physical activity, the inability to evaluate the association between physical activity and CAC levels with incident cardiovascular events because of a lack of data, and the lack of information on incident myocardial infarction, stroke, CAC density, or volume.
Physical activity might increase coronary atherosclerosis through mechanical stress and vessel wall injury of coronary arteries; physiologic responses during exercise, such as increased blood pressure; increased parathyroid hormone levels; and changes in coronary hemodynamics and inflammation. “In addition, other factors, such as diet, vitamins, and minerals, may change with physical activity,” the authors write.
“The second possibility is that physical activity may increase CAC scores without increasing cardiovascular disease risk,” they write.
“The cardiovascular benefits of physical activity are unquestionable,” the authors emphasize, adding that the national guidelines recommend at least 150 to 300 minutes per week of moderate-intensity or 75 to 150 minutes per week of vigorous-intensity aerobic physical activity.
“Patients and physicians, however, need to consider that engaging in physical activity may accelerate the progression of coronary calcium, possibly due to plaque healing, stabilization and calcification,” they conclude.
Dr. Guallar added: “We would like to link our research to clinical outcomes, so that we can really be sure that the increase in coronary calcium scores does not imply an increase in risk.”
“Do these findings mean that we should stop using coronary artery calcium scores to assess coronary artery disease?” ask Gaurav Gulsin, MD, and Alastair James Moss, MD, University of Leicester, United Kingdom, in an accompanying editorial.
The study highlights the complexity of interpreting CAC scores in patients who have implemented recommendations for physical activity or started statin therapy, they note.
“While proponents would argue that it is an effective tool to screen for subclinical atherosclerosis in asymptomatic individuals, clinicians should be cautious regarding the overuse of this test in otherwise healthy individuals. The coronary artery calcium paradox should not result in paradoxical care for our patients,” Dr. Gulsin and Dr. Moss conclude.
Dr. Sung, Dr. Hong, and the other study authors report no relevant financial relationships. The British Heart Foundation provides funding support for Dr. Gulsin and Dr. Moss.
A version of this article first appeared on Medscape.com.
new observational data suggest.
In a prospective cohort study of Korean men and women 18 years and older, participants who were the most physically active had the fastest progression of their coronary artery calcium (CAC) scores at 5 years, compared with those who were the least physically active.
“People who exercise may have an increase in their coronary calcium levels, but this is not necessarily bad news. This may mean that atherosclerotic lesions in the coronary arteries are becoming more stable and less dangerous, but we need additional research to understand these changes,” Eliseo Guallar, MD, PhD, professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, the study’s corresponding author, said in an interview.
This paradoxical effect notwithstanding, doctors should continue to advise their patients to follow the physical activity guidelines for Americans that were published in 2018, Dr. Guallar said.
“Physical activity is a key component of a healthy lifestyle. Our analysis can be useful, however, if someone starts exercising and sees that his or her coronary calcium score goes up,” he said.
The study is published online September 20 in Heart.
The degree of build-up of calcium deposits in the coronary arteries is used to determine future cardiovascular disease risk and to guide treatment to prevent myocardial infarction and stroke. A CAC score of at least 100 Agatston units indicates that treatment with statins is warranted, the researchers write.
In the current study, investigators — led by Ki-Chul Sung, MD, Sungkyunkwan University School of Medicine, Seoul, Korea, and Yun Soo Hong, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore — explored the link between different degrees of physical activity and the progression of CAC scores in healthy adults.
“While physical activity improves a wide array of cardiovascular and metabolic biomarkers, endurance athletes were more likely to have a coronary artery calcium (CAC) score >300 Agatston units or coronary plaques compared with sedentary men with a similar risk profile. It is not clear if exercise may itself be associated with calcification of the arteries,” the authors write.
The researchers studied 25,485 participants (22,741 men and 2,744 women) who were part of the Kangbuk Samsung Health Study. All were free of cardiovascular disease at study entry and underwent comprehensive health screening exams at one of two major health centers in Seoul and Suwon, South Korea, between March 1, 2011, and December 31, 2017.
At each exam, participants filled out a questionnaire that included questions on medical and family history, smoking habits, alcohol intake, and education level.
Participants were also quizzed at baseline about their physical activity, using the Korean version of the International Physical Activity Questionnaire Short Form (IPAQ-SF).
On the basis of that, they were categorized into one of three categories: inactive; moderately active, defined as at least 3 days of vigorous-intensity activity for at least 20 min/day or at least 5 days of moderate-intensity activity or walking for at least 30 min/ day or at least 5 days of any combination of walking and moderate- or vigorous-intensity activities, attaining at least 600 MET-min/week; or health-enhancing physically active (HEPA), defined as at least 3 days of vigorous-intensity activity, attaining at least 1,500 MET-min/week or 7 days of any combination of walking or moderate- or vigorous-intensity activities, attaining at least 3000 MET-min/week.
Of the study participants, 47% were classified as inactive, 38% as moderately active, and 15% as HEPA.
Those who were more physically active tended to be older and less likely to smoke than less physically active participants. They also had lower total cholesterol, more hypertension, and existing evidence of calcium deposits in their coronary arteries.
A graded association between physical activity level and the prevalence and progression of coronary artery calcification was seen, irrespective of CAC scores at the start of monitoring.
At baseline, the estimated adjusted average baseline CAC scores in inactive participants was 9.45 (95% CI, 8.76 - 10.14), in moderately active participants was 10.20 (95% CI, 9.40 - 11.00), and in HEPA participants was 12.04 (95% CI, 10.81 - 13.26).
Compared with the least active participants, the estimated adjusted 5-year average increases in CAC was 3.20 (95% CI, 0.72 - 5.69) in moderately active participants and 8.16 (95% CI, 4.80 - 11.53) in HEPA participants.
A higher level of physical activity was associated with faster progression of CAC scores, both in participants with CAC score of 0 at baseline and in those with prevalent CAC.
The authors note there are several limitations to consider when interpreting their findings. These include the absence of an objective assessment of physical activity, the inability to evaluate the association between physical activity and CAC levels with incident cardiovascular events because of a lack of data, and the lack of information on incident myocardial infarction, stroke, CAC density, or volume.
Physical activity might increase coronary atherosclerosis through mechanical stress and vessel wall injury of coronary arteries; physiologic responses during exercise, such as increased blood pressure; increased parathyroid hormone levels; and changes in coronary hemodynamics and inflammation. “In addition, other factors, such as diet, vitamins, and minerals, may change with physical activity,” the authors write.
“The second possibility is that physical activity may increase CAC scores without increasing cardiovascular disease risk,” they write.
“The cardiovascular benefits of physical activity are unquestionable,” the authors emphasize, adding that the national guidelines recommend at least 150 to 300 minutes per week of moderate-intensity or 75 to 150 minutes per week of vigorous-intensity aerobic physical activity.
“Patients and physicians, however, need to consider that engaging in physical activity may accelerate the progression of coronary calcium, possibly due to plaque healing, stabilization and calcification,” they conclude.
Dr. Guallar added: “We would like to link our research to clinical outcomes, so that we can really be sure that the increase in coronary calcium scores does not imply an increase in risk.”
“Do these findings mean that we should stop using coronary artery calcium scores to assess coronary artery disease?” ask Gaurav Gulsin, MD, and Alastair James Moss, MD, University of Leicester, United Kingdom, in an accompanying editorial.
The study highlights the complexity of interpreting CAC scores in patients who have implemented recommendations for physical activity or started statin therapy, they note.
“While proponents would argue that it is an effective tool to screen for subclinical atherosclerosis in asymptomatic individuals, clinicians should be cautious regarding the overuse of this test in otherwise healthy individuals. The coronary artery calcium paradox should not result in paradoxical care for our patients,” Dr. Gulsin and Dr. Moss conclude.
Dr. Sung, Dr. Hong, and the other study authors report no relevant financial relationships. The British Heart Foundation provides funding support for Dr. Gulsin and Dr. Moss.
A version of this article first appeared on Medscape.com.
new observational data suggest.
In a prospective cohort study of Korean men and women 18 years and older, participants who were the most physically active had the fastest progression of their coronary artery calcium (CAC) scores at 5 years, compared with those who were the least physically active.
“People who exercise may have an increase in their coronary calcium levels, but this is not necessarily bad news. This may mean that atherosclerotic lesions in the coronary arteries are becoming more stable and less dangerous, but we need additional research to understand these changes,” Eliseo Guallar, MD, PhD, professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, the study’s corresponding author, said in an interview.
This paradoxical effect notwithstanding, doctors should continue to advise their patients to follow the physical activity guidelines for Americans that were published in 2018, Dr. Guallar said.
“Physical activity is a key component of a healthy lifestyle. Our analysis can be useful, however, if someone starts exercising and sees that his or her coronary calcium score goes up,” he said.
The study is published online September 20 in Heart.
The degree of build-up of calcium deposits in the coronary arteries is used to determine future cardiovascular disease risk and to guide treatment to prevent myocardial infarction and stroke. A CAC score of at least 100 Agatston units indicates that treatment with statins is warranted, the researchers write.
In the current study, investigators — led by Ki-Chul Sung, MD, Sungkyunkwan University School of Medicine, Seoul, Korea, and Yun Soo Hong, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore — explored the link between different degrees of physical activity and the progression of CAC scores in healthy adults.
“While physical activity improves a wide array of cardiovascular and metabolic biomarkers, endurance athletes were more likely to have a coronary artery calcium (CAC) score >300 Agatston units or coronary plaques compared with sedentary men with a similar risk profile. It is not clear if exercise may itself be associated with calcification of the arteries,” the authors write.
The researchers studied 25,485 participants (22,741 men and 2,744 women) who were part of the Kangbuk Samsung Health Study. All were free of cardiovascular disease at study entry and underwent comprehensive health screening exams at one of two major health centers in Seoul and Suwon, South Korea, between March 1, 2011, and December 31, 2017.
At each exam, participants filled out a questionnaire that included questions on medical and family history, smoking habits, alcohol intake, and education level.
Participants were also quizzed at baseline about their physical activity, using the Korean version of the International Physical Activity Questionnaire Short Form (IPAQ-SF).
On the basis of that, they were categorized into one of three categories: inactive; moderately active, defined as at least 3 days of vigorous-intensity activity for at least 20 min/day or at least 5 days of moderate-intensity activity or walking for at least 30 min/ day or at least 5 days of any combination of walking and moderate- or vigorous-intensity activities, attaining at least 600 MET-min/week; or health-enhancing physically active (HEPA), defined as at least 3 days of vigorous-intensity activity, attaining at least 1,500 MET-min/week or 7 days of any combination of walking or moderate- or vigorous-intensity activities, attaining at least 3000 MET-min/week.
Of the study participants, 47% were classified as inactive, 38% as moderately active, and 15% as HEPA.
Those who were more physically active tended to be older and less likely to smoke than less physically active participants. They also had lower total cholesterol, more hypertension, and existing evidence of calcium deposits in their coronary arteries.
A graded association between physical activity level and the prevalence and progression of coronary artery calcification was seen, irrespective of CAC scores at the start of monitoring.
At baseline, the estimated adjusted average baseline CAC scores in inactive participants was 9.45 (95% CI, 8.76 - 10.14), in moderately active participants was 10.20 (95% CI, 9.40 - 11.00), and in HEPA participants was 12.04 (95% CI, 10.81 - 13.26).
Compared with the least active participants, the estimated adjusted 5-year average increases in CAC was 3.20 (95% CI, 0.72 - 5.69) in moderately active participants and 8.16 (95% CI, 4.80 - 11.53) in HEPA participants.
A higher level of physical activity was associated with faster progression of CAC scores, both in participants with CAC score of 0 at baseline and in those with prevalent CAC.
The authors note there are several limitations to consider when interpreting their findings. These include the absence of an objective assessment of physical activity, the inability to evaluate the association between physical activity and CAC levels with incident cardiovascular events because of a lack of data, and the lack of information on incident myocardial infarction, stroke, CAC density, or volume.
Physical activity might increase coronary atherosclerosis through mechanical stress and vessel wall injury of coronary arteries; physiologic responses during exercise, such as increased blood pressure; increased parathyroid hormone levels; and changes in coronary hemodynamics and inflammation. “In addition, other factors, such as diet, vitamins, and minerals, may change with physical activity,” the authors write.
“The second possibility is that physical activity may increase CAC scores without increasing cardiovascular disease risk,” they write.
“The cardiovascular benefits of physical activity are unquestionable,” the authors emphasize, adding that the national guidelines recommend at least 150 to 300 minutes per week of moderate-intensity or 75 to 150 minutes per week of vigorous-intensity aerobic physical activity.
“Patients and physicians, however, need to consider that engaging in physical activity may accelerate the progression of coronary calcium, possibly due to plaque healing, stabilization and calcification,” they conclude.
Dr. Guallar added: “We would like to link our research to clinical outcomes, so that we can really be sure that the increase in coronary calcium scores does not imply an increase in risk.”
“Do these findings mean that we should stop using coronary artery calcium scores to assess coronary artery disease?” ask Gaurav Gulsin, MD, and Alastair James Moss, MD, University of Leicester, United Kingdom, in an accompanying editorial.
The study highlights the complexity of interpreting CAC scores in patients who have implemented recommendations for physical activity or started statin therapy, they note.
“While proponents would argue that it is an effective tool to screen for subclinical atherosclerosis in asymptomatic individuals, clinicians should be cautious regarding the overuse of this test in otherwise healthy individuals. The coronary artery calcium paradox should not result in paradoxical care for our patients,” Dr. Gulsin and Dr. Moss conclude.
Dr. Sung, Dr. Hong, and the other study authors report no relevant financial relationships. The British Heart Foundation provides funding support for Dr. Gulsin and Dr. Moss.
A version of this article first appeared on Medscape.com.
Lifestyle interventions improve resistant hypertension
A 4-month, structured diet and exercise intervention lowered blood pressure in adults with resistant blood pressure, according to results from a randomized, clinical trial. The program also led to improvements in baroreflex sensitivity, heart rate variability, and flow-mediated dilation, compared with individuals who received only a single education session.
The intervention included instruction from a nutritionist on how to follow the Dietary Approaches to Stop Hypertension (DASH) diet, as well as restricting calories and sodium to less than 2,300 mg/day. It included weekly, 45-minute group counseling sessions, run by a clinical psychiatrist, focusing on eating behaviors. The exercise component included 30- to 45-minute sessions at 70%-85% of initial heart rate reserve, carried out three times per week at a cardiac rehabilitation facility.
“While some individuals can make the lifestyle changes on their own, a structured program of supervised exercise and dietary modification conducted by a multidisciplinary team of physicians, psychologists, nutritionists, and physical therapists/exercise physiologists found in cardiac rehabilitation programs throughout the country is likely to be more effective. There are many cardiac rehabilitation programs throughout the country that are accessible to most patients,” said lead author James Blumenthal, PhD, the J.P. Gibbons Professor in Psychiatry and Behavioral Sciences at Duke University, Durham, N.C.
The study, called Treating Resistant Hypertension Using Lifestyle Modification to Promote Health (TRIUMPH), was published in Circulation. It is one of few that have examined lifestyle interventions in resistant hypertension, defined as systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80 mm Hg after adherence to three or more optimally-dosed antihypertensive medications of three different classes, including one diuretic.
“This is a nice study [that] emphasizes what we often forget: Lifestyle factors, especially salt intake, are important drivers of resistant hypertension. Our own studies have shown that this is predominantly a salt retaining state, and one would expect dietary salt restriction to be particularly effective in this group of patients and that is what this study showed,” said Bryan Williams, MD, who was asked to comment on the study. Dr. Williams is chair of medicine at University College London.
The results should also be reassuring to some who worried that exercise might lead to worsened blood pressure. “This study showed that in patients with resistant hypertension, though not out of control blood pressures, exercise was not only safe, but effective in lowering their blood pressure,” said Deepak L. Bhatt, MD, MPH, who was asked to comment. He is executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, both in Boston.
The new research isn’t unique. In August, researchers in Portugal and Brazil showed that a 12-week exercise-only intervention reduced 24-hour and daytime ambulatory systolic and diastolic blood pressure. The two studies communicate the same message. “Lifestyle changes can work for resistant hypertension. So, two independent, modest-sized studies with essentially the same, positive, actionable conclusion,” said Dr. Bhatt, adding that the next step should be a larger, multicenter trial.
In the new study, 90 patients were assigned to the diet and exercise intervention and 50 to the control group. They had a mean age of 63 years, and 48% were women. Participants attended 94% of DASH diet classes and 89% of exercise sessions, and both groups had excellent adherence to medications.
The treatment group had a greater reduction in clinic systolic BP (–12.5 versus –7.1 mm Hg; P = .005) and diastolic BP (–5.9 versus –3.7 mm Hg; P = .034), as well as 24-hour ambulatory systolic BP (–7.0 versus –0.3 mm Hg; P = .001). The treatment group also had more improvement in resting baroreflex sensitivity (2.3 versus –1.1 ms/mm Hg; P = .003), high-frequency heart rate variability (0.4 versus –0.2 ln ms2; P = .025, and flow-mediated dilation (0.3% versus –1.4%, P = .022). The two groups had similar outcomes with respect to pulse wave velocity and left ventricular mass.
“Results of the TRIUMPH study suggest that policymakers should consider resistant hypertension as a new indication for cardiac rehabilitation with appropriate coverage by governmental agencies and private insurers,” Dr. Blumenthal said.
“This is an important new, evidence-based intervention for resistant hypertension. It is safe and relatively inexpensive. It should now be something physicians routinely offer these patients. Hopefully in the future, insurers will cover cardiac rehabilitation for patients with resistant hypertension,” Dr. Bhatt said.
The study also pointed towards an effective approach for patients who may be unable to sustain lifestyle changes. “Of course, not every patient will be able to maintain a healthy diet and an exercise program on their own, thus a cardiac rehabilitation program can be an excellent way to increase the likelihood of successful lifestyle modification,” Dr. Bhatt said.
TRIUMPH was sponsored by grants from the National Heart, Lung, and Blood Institute. None of the authors had disclosures to report. Dr. Bhatt disclosed having financial relationships with more than 40 pharmaceutical companies. Dr. Williams reported having no relevant financial disclosures.
A 4-month, structured diet and exercise intervention lowered blood pressure in adults with resistant blood pressure, according to results from a randomized, clinical trial. The program also led to improvements in baroreflex sensitivity, heart rate variability, and flow-mediated dilation, compared with individuals who received only a single education session.
The intervention included instruction from a nutritionist on how to follow the Dietary Approaches to Stop Hypertension (DASH) diet, as well as restricting calories and sodium to less than 2,300 mg/day. It included weekly, 45-minute group counseling sessions, run by a clinical psychiatrist, focusing on eating behaviors. The exercise component included 30- to 45-minute sessions at 70%-85% of initial heart rate reserve, carried out three times per week at a cardiac rehabilitation facility.
“While some individuals can make the lifestyle changes on their own, a structured program of supervised exercise and dietary modification conducted by a multidisciplinary team of physicians, psychologists, nutritionists, and physical therapists/exercise physiologists found in cardiac rehabilitation programs throughout the country is likely to be more effective. There are many cardiac rehabilitation programs throughout the country that are accessible to most patients,” said lead author James Blumenthal, PhD, the J.P. Gibbons Professor in Psychiatry and Behavioral Sciences at Duke University, Durham, N.C.
The study, called Treating Resistant Hypertension Using Lifestyle Modification to Promote Health (TRIUMPH), was published in Circulation. It is one of few that have examined lifestyle interventions in resistant hypertension, defined as systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80 mm Hg after adherence to three or more optimally-dosed antihypertensive medications of three different classes, including one diuretic.
“This is a nice study [that] emphasizes what we often forget: Lifestyle factors, especially salt intake, are important drivers of resistant hypertension. Our own studies have shown that this is predominantly a salt retaining state, and one would expect dietary salt restriction to be particularly effective in this group of patients and that is what this study showed,” said Bryan Williams, MD, who was asked to comment on the study. Dr. Williams is chair of medicine at University College London.
The results should also be reassuring to some who worried that exercise might lead to worsened blood pressure. “This study showed that in patients with resistant hypertension, though not out of control blood pressures, exercise was not only safe, but effective in lowering their blood pressure,” said Deepak L. Bhatt, MD, MPH, who was asked to comment. He is executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, both in Boston.
The new research isn’t unique. In August, researchers in Portugal and Brazil showed that a 12-week exercise-only intervention reduced 24-hour and daytime ambulatory systolic and diastolic blood pressure. The two studies communicate the same message. “Lifestyle changes can work for resistant hypertension. So, two independent, modest-sized studies with essentially the same, positive, actionable conclusion,” said Dr. Bhatt, adding that the next step should be a larger, multicenter trial.
In the new study, 90 patients were assigned to the diet and exercise intervention and 50 to the control group. They had a mean age of 63 years, and 48% were women. Participants attended 94% of DASH diet classes and 89% of exercise sessions, and both groups had excellent adherence to medications.
The treatment group had a greater reduction in clinic systolic BP (–12.5 versus –7.1 mm Hg; P = .005) and diastolic BP (–5.9 versus –3.7 mm Hg; P = .034), as well as 24-hour ambulatory systolic BP (–7.0 versus –0.3 mm Hg; P = .001). The treatment group also had more improvement in resting baroreflex sensitivity (2.3 versus –1.1 ms/mm Hg; P = .003), high-frequency heart rate variability (0.4 versus –0.2 ln ms2; P = .025, and flow-mediated dilation (0.3% versus –1.4%, P = .022). The two groups had similar outcomes with respect to pulse wave velocity and left ventricular mass.
“Results of the TRIUMPH study suggest that policymakers should consider resistant hypertension as a new indication for cardiac rehabilitation with appropriate coverage by governmental agencies and private insurers,” Dr. Blumenthal said.
“This is an important new, evidence-based intervention for resistant hypertension. It is safe and relatively inexpensive. It should now be something physicians routinely offer these patients. Hopefully in the future, insurers will cover cardiac rehabilitation for patients with resistant hypertension,” Dr. Bhatt said.
The study also pointed towards an effective approach for patients who may be unable to sustain lifestyle changes. “Of course, not every patient will be able to maintain a healthy diet and an exercise program on their own, thus a cardiac rehabilitation program can be an excellent way to increase the likelihood of successful lifestyle modification,” Dr. Bhatt said.
TRIUMPH was sponsored by grants from the National Heart, Lung, and Blood Institute. None of the authors had disclosures to report. Dr. Bhatt disclosed having financial relationships with more than 40 pharmaceutical companies. Dr. Williams reported having no relevant financial disclosures.
A 4-month, structured diet and exercise intervention lowered blood pressure in adults with resistant blood pressure, according to results from a randomized, clinical trial. The program also led to improvements in baroreflex sensitivity, heart rate variability, and flow-mediated dilation, compared with individuals who received only a single education session.
The intervention included instruction from a nutritionist on how to follow the Dietary Approaches to Stop Hypertension (DASH) diet, as well as restricting calories and sodium to less than 2,300 mg/day. It included weekly, 45-minute group counseling sessions, run by a clinical psychiatrist, focusing on eating behaviors. The exercise component included 30- to 45-minute sessions at 70%-85% of initial heart rate reserve, carried out three times per week at a cardiac rehabilitation facility.
“While some individuals can make the lifestyle changes on their own, a structured program of supervised exercise and dietary modification conducted by a multidisciplinary team of physicians, psychologists, nutritionists, and physical therapists/exercise physiologists found in cardiac rehabilitation programs throughout the country is likely to be more effective. There are many cardiac rehabilitation programs throughout the country that are accessible to most patients,” said lead author James Blumenthal, PhD, the J.P. Gibbons Professor in Psychiatry and Behavioral Sciences at Duke University, Durham, N.C.
The study, called Treating Resistant Hypertension Using Lifestyle Modification to Promote Health (TRIUMPH), was published in Circulation. It is one of few that have examined lifestyle interventions in resistant hypertension, defined as systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80 mm Hg after adherence to three or more optimally-dosed antihypertensive medications of three different classes, including one diuretic.
“This is a nice study [that] emphasizes what we often forget: Lifestyle factors, especially salt intake, are important drivers of resistant hypertension. Our own studies have shown that this is predominantly a salt retaining state, and one would expect dietary salt restriction to be particularly effective in this group of patients and that is what this study showed,” said Bryan Williams, MD, who was asked to comment on the study. Dr. Williams is chair of medicine at University College London.
The results should also be reassuring to some who worried that exercise might lead to worsened blood pressure. “This study showed that in patients with resistant hypertension, though not out of control blood pressures, exercise was not only safe, but effective in lowering their blood pressure,” said Deepak L. Bhatt, MD, MPH, who was asked to comment. He is executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, both in Boston.
The new research isn’t unique. In August, researchers in Portugal and Brazil showed that a 12-week exercise-only intervention reduced 24-hour and daytime ambulatory systolic and diastolic blood pressure. The two studies communicate the same message. “Lifestyle changes can work for resistant hypertension. So, two independent, modest-sized studies with essentially the same, positive, actionable conclusion,” said Dr. Bhatt, adding that the next step should be a larger, multicenter trial.
In the new study, 90 patients were assigned to the diet and exercise intervention and 50 to the control group. They had a mean age of 63 years, and 48% were women. Participants attended 94% of DASH diet classes and 89% of exercise sessions, and both groups had excellent adherence to medications.
The treatment group had a greater reduction in clinic systolic BP (–12.5 versus –7.1 mm Hg; P = .005) and diastolic BP (–5.9 versus –3.7 mm Hg; P = .034), as well as 24-hour ambulatory systolic BP (–7.0 versus –0.3 mm Hg; P = .001). The treatment group also had more improvement in resting baroreflex sensitivity (2.3 versus –1.1 ms/mm Hg; P = .003), high-frequency heart rate variability (0.4 versus –0.2 ln ms2; P = .025, and flow-mediated dilation (0.3% versus –1.4%, P = .022). The two groups had similar outcomes with respect to pulse wave velocity and left ventricular mass.
“Results of the TRIUMPH study suggest that policymakers should consider resistant hypertension as a new indication for cardiac rehabilitation with appropriate coverage by governmental agencies and private insurers,” Dr. Blumenthal said.
“This is an important new, evidence-based intervention for resistant hypertension. It is safe and relatively inexpensive. It should now be something physicians routinely offer these patients. Hopefully in the future, insurers will cover cardiac rehabilitation for patients with resistant hypertension,” Dr. Bhatt said.
The study also pointed towards an effective approach for patients who may be unable to sustain lifestyle changes. “Of course, not every patient will be able to maintain a healthy diet and an exercise program on their own, thus a cardiac rehabilitation program can be an excellent way to increase the likelihood of successful lifestyle modification,” Dr. Bhatt said.
TRIUMPH was sponsored by grants from the National Heart, Lung, and Blood Institute. None of the authors had disclosures to report. Dr. Bhatt disclosed having financial relationships with more than 40 pharmaceutical companies. Dr. Williams reported having no relevant financial disclosures.
FROM CIRCULATION
Apple devices identify early Parkinson’s disease
, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.
“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
WATCH-PD
The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.
Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.
Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.
The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.
In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.
Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
Between-group differences
Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.
Similarly, the control group performed better than the Parkinson’s disease group on the Montreal Cognitive Assessment (MoCA), with higher scores showing better performance on the 0 to 30 scale (28.1 vs. 27.6, respectively).
Touchscreen assessments on the phone also showed group differences in a finger-tapping task, with more taps by the control group than by the Parkinson’s disease group. The difference was more pronounced when the dominant hand was used.
The median numbers of taps in 20 seconds for the dominant hand were 103.7 for the Parkinson’s disease cohort versus 131.9 for control cohort (P < .005); and for the nondominant hand the numbers of taps were 106.6 versus 122.1 (P < .05), respectively. The control group also scored better on tests of hand fine-motor control (P < .01) and on the mobile digit symbols modalities test (P < .05)
Measures of gait in a 1-minute walk test also showed group differences.
“The five gait measures that differed most were cadence, which is steps per minute, double support, arm swing amplitude, arm swing variation, and turn duration,” Dr. Adams said.
‘Tremendous interest’
Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.
That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.
The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.
“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.
She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.
Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”
Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.
Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.
“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.
Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.
The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.
“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
WATCH-PD
The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.
Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.
Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.
The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.
In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.
Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
Between-group differences
Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.
Similarly, the control group performed better than the Parkinson’s disease group on the Montreal Cognitive Assessment (MoCA), with higher scores showing better performance on the 0 to 30 scale (28.1 vs. 27.6, respectively).
Touchscreen assessments on the phone also showed group differences in a finger-tapping task, with more taps by the control group than by the Parkinson’s disease group. The difference was more pronounced when the dominant hand was used.
The median numbers of taps in 20 seconds for the dominant hand were 103.7 for the Parkinson’s disease cohort versus 131.9 for control cohort (P < .005); and for the nondominant hand the numbers of taps were 106.6 versus 122.1 (P < .05), respectively. The control group also scored better on tests of hand fine-motor control (P < .01) and on the mobile digit symbols modalities test (P < .05)
Measures of gait in a 1-minute walk test also showed group differences.
“The five gait measures that differed most were cadence, which is steps per minute, double support, arm swing amplitude, arm swing variation, and turn duration,” Dr. Adams said.
‘Tremendous interest’
Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.
That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.
The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.
“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.
She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.
Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”
Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.
Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.
“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.
Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.
The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.
“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
WATCH-PD
The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.
Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.
Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.
The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.
In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.
Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
Between-group differences
Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.
Similarly, the control group performed better than the Parkinson’s disease group on the Montreal Cognitive Assessment (MoCA), with higher scores showing better performance on the 0 to 30 scale (28.1 vs. 27.6, respectively).
Touchscreen assessments on the phone also showed group differences in a finger-tapping task, with more taps by the control group than by the Parkinson’s disease group. The difference was more pronounced when the dominant hand was used.
The median numbers of taps in 20 seconds for the dominant hand were 103.7 for the Parkinson’s disease cohort versus 131.9 for control cohort (P < .005); and for the nondominant hand the numbers of taps were 106.6 versus 122.1 (P < .05), respectively. The control group also scored better on tests of hand fine-motor control (P < .01) and on the mobile digit symbols modalities test (P < .05)
Measures of gait in a 1-minute walk test also showed group differences.
“The five gait measures that differed most were cadence, which is steps per minute, double support, arm swing amplitude, arm swing variation, and turn duration,” Dr. Adams said.
‘Tremendous interest’
Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.
That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.
The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.
“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.
She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.
Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”
Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.
Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.
“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.
Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.
The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MDS VIRTUAL CONGRESS 2021
The soccer punch
Soccer is the most popular sport on Earth.
A recent JAMA Neurology article noted the incidence of neurodegenerative disease in retired professional soccer players. It found that, not surprisingly, the frequency of such was higher than in the general population, highest amongst defenders and lowest in goalkeepers (presumably because the latter can use their hands).
The point here shouldn’t surprise anyone: Repeatedly hitting your head on solid objects is a bad idea.
Somewhere, a long time ago, early vertebrates developed a bony case to protect their centralized nervous system. Its success is shown by the fact that skulls and spinal cords among vertebrates have more similarities than differences: They work. It’s true that some ungulates use their heads to fight, but their skulls are adapted for such, being thicker and having horns and antlers to lessen the impacts.
But humans? Nope. The skull can support up to nine tons of (slowly-applied) weight (don’t try this at home) but repeated impacts aren’t good for its contents.
There is no degree of external protection that will prevent this, either. We talk about helmets, but the reality is that, while they definitely reduce exterior injuries, they do very little to prevent the effects of rapid acceleration/deceleration on the brain inside. This is what results in concussions, coup & contra-coup injuries, and the shearing effects of diffuse axonal injury.
I’m not saying we should ban soccer, or football, or any of the other activities that clearly have a high risk of repeated head trauma. They’re ingrained into the cultures of our societies.
At this point it’s pretty much impossible for participants and their family members to not be aware of the risks posed by these sports. The popular press has covered it in great detail.
At some point there’s only so much you can warn people about. Like tobacco smoking or riding without a helmet, you accept the risks, fully aware of the serious potential consequences. For those who wish to participate, it’s their decision.
But it’s also time to stop blinding ourselves to the simple facts. Minimizing them, pointing out their delayed onset, and turning a blind eye won’t change that.
If we’re going to continue enjoying contact sports, we have to accept that someone is going to pay the price for it, even if they’ve been forewarned. And no amount of protective gear, at today’s technology, is going to change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Soccer is the most popular sport on Earth.
A recent JAMA Neurology article noted the incidence of neurodegenerative disease in retired professional soccer players. It found that, not surprisingly, the frequency of such was higher than in the general population, highest amongst defenders and lowest in goalkeepers (presumably because the latter can use their hands).
The point here shouldn’t surprise anyone: Repeatedly hitting your head on solid objects is a bad idea.
Somewhere, a long time ago, early vertebrates developed a bony case to protect their centralized nervous system. Its success is shown by the fact that skulls and spinal cords among vertebrates have more similarities than differences: They work. It’s true that some ungulates use their heads to fight, but their skulls are adapted for such, being thicker and having horns and antlers to lessen the impacts.
But humans? Nope. The skull can support up to nine tons of (slowly-applied) weight (don’t try this at home) but repeated impacts aren’t good for its contents.
There is no degree of external protection that will prevent this, either. We talk about helmets, but the reality is that, while they definitely reduce exterior injuries, they do very little to prevent the effects of rapid acceleration/deceleration on the brain inside. This is what results in concussions, coup & contra-coup injuries, and the shearing effects of diffuse axonal injury.
I’m not saying we should ban soccer, or football, or any of the other activities that clearly have a high risk of repeated head trauma. They’re ingrained into the cultures of our societies.
At this point it’s pretty much impossible for participants and their family members to not be aware of the risks posed by these sports. The popular press has covered it in great detail.
At some point there’s only so much you can warn people about. Like tobacco smoking or riding without a helmet, you accept the risks, fully aware of the serious potential consequences. For those who wish to participate, it’s their decision.
But it’s also time to stop blinding ourselves to the simple facts. Minimizing them, pointing out their delayed onset, and turning a blind eye won’t change that.
If we’re going to continue enjoying contact sports, we have to accept that someone is going to pay the price for it, even if they’ve been forewarned. And no amount of protective gear, at today’s technology, is going to change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Soccer is the most popular sport on Earth.
A recent JAMA Neurology article noted the incidence of neurodegenerative disease in retired professional soccer players. It found that, not surprisingly, the frequency of such was higher than in the general population, highest amongst defenders and lowest in goalkeepers (presumably because the latter can use their hands).
The point here shouldn’t surprise anyone: Repeatedly hitting your head on solid objects is a bad idea.
Somewhere, a long time ago, early vertebrates developed a bony case to protect their centralized nervous system. Its success is shown by the fact that skulls and spinal cords among vertebrates have more similarities than differences: They work. It’s true that some ungulates use their heads to fight, but their skulls are adapted for such, being thicker and having horns and antlers to lessen the impacts.
But humans? Nope. The skull can support up to nine tons of (slowly-applied) weight (don’t try this at home) but repeated impacts aren’t good for its contents.
There is no degree of external protection that will prevent this, either. We talk about helmets, but the reality is that, while they definitely reduce exterior injuries, they do very little to prevent the effects of rapid acceleration/deceleration on the brain inside. This is what results in concussions, coup & contra-coup injuries, and the shearing effects of diffuse axonal injury.
I’m not saying we should ban soccer, or football, or any of the other activities that clearly have a high risk of repeated head trauma. They’re ingrained into the cultures of our societies.
At this point it’s pretty much impossible for participants and their family members to not be aware of the risks posed by these sports. The popular press has covered it in great detail.
At some point there’s only so much you can warn people about. Like tobacco smoking or riding without a helmet, you accept the risks, fully aware of the serious potential consequences. For those who wish to participate, it’s their decision.
But it’s also time to stop blinding ourselves to the simple facts. Minimizing them, pointing out their delayed onset, and turning a blind eye won’t change that.
If we’re going to continue enjoying contact sports, we have to accept that someone is going to pay the price for it, even if they’ve been forewarned. And no amount of protective gear, at today’s technology, is going to change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Updates to CDC’s STI guidelines relevant to midlife women too
Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.
That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.
Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
Sexual history
The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.
“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”
In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.
When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.
After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:
- History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
- More than 1 sexual partner in the past year.
- New sexual partner within 90 days.
- Reason to believe that a sex partner has had other partners in the past year.
- Exchanging sex for drugs or money within the past year.
- Other factors identified locally, including prevalence of infection in the community.
STI screening guidelines
For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.
For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.
HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.
Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.
Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
STI treatment guidelines
For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.
The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.
Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.
For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.
The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.
”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.
The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.
“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.
Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.
“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”
Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.
“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.
Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.
Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.
Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.
Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.
That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.
Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
Sexual history
The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.
“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”
In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.
When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.
After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:
- History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
- More than 1 sexual partner in the past year.
- New sexual partner within 90 days.
- Reason to believe that a sex partner has had other partners in the past year.
- Exchanging sex for drugs or money within the past year.
- Other factors identified locally, including prevalence of infection in the community.
STI screening guidelines
For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.
For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.
HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.
Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.
Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
STI treatment guidelines
For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.
The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.
Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.
For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.
The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.
”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.
The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.
“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.
Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.
“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”
Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.
“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.
Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.
Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.
Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.
Sexually transmitted infection rates have not increased as dramatically in older women as they have in women in their teens and 20s, but rates of chlamydia and gonorrhea in women over age 35 have seen a steady incline over the past decade, and syphilis rates have climbed steeply, according to data from the Centers for Disease Control and Prevention.
That makes the STI treatment guidelines released by the CDC in July even timelier for practitioners of menopause medicine, according to Michael S. Policar, MD, MPH, a professor emeritus of ob.gyn. and reproductive sciences at the University of California, San Francisco.
Dr. Policar discussed what clinicians need to know about STIs in midlife women at the hybrid annual meeting of the North American Menopause Society. Even the nomenclature change in the guidelines from “sexually transmitted diseases” to “sexually transmitted infections” is important “because they want to acknowledge the fact that a lot of the sexually transmitted infections that we’re treating are asymptomatic, are colonizations, and are not yet diseases,” Dr. Policar said. “We’re trying to be much more expansive in thinking about finding these infections before they actually start causing morbidity in the form of a disease.”
Sexual history
The primary guidelines update for taking sexual history is the recommendation to ask patients about their intentions regarding pregnancy. The “5 Ps” of sexual history are now Partners, Practices, Protection from STIs, Past history of STIs, and Pregnancy intention.
“There should be a sixth P that has to do with pleasure questions,” Policar added. “We ask all the time for patients that we see in the context of perimenopausal and menopausal services, ‘Are you satisfied with your sexual relationship with your partner?’ Hopefully that will make it into the CDC guidelines as the sixth P at some point, but for now, that’s aspirational.”
In asking about partners, instead of asking patients whether they have sex with men, women, or both, clinicians should ask first if the patient is having sex of any kind – oral, vaginal, or anal – with anyone. From there, providers should ask how many sex partners the patient has had, the gender(s) of the partners, and whether they or their partners have other sex partners, using more gender-inclusive language.
When asking about practices, in addition to asking about the type of sexual contact patients have had, additional questions include whether the patient met their partners online or through apps, whether they or any of their partners use drugs, and whether the patient has exchanged sex for any needs, such as money, housing, or drugs. The additional questions can identify those at higher risk for STIs.
After reviewing the CDC’s list of risk factors for gonorrhea and chlamydia screening, Dr. Policar shared the screening list from the California Department of Public Health, which he finds more helpful:
- History of gonorrhea, chlamydia, or pelvic inflammatory disease (PID) in the past 2 years.
- More than 1 sexual partner in the past year.
- New sexual partner within 90 days.
- Reason to believe that a sex partner has had other partners in the past year.
- Exchanging sex for drugs or money within the past year.
- Other factors identified locally, including prevalence of infection in the community.
STI screening guidelines
For those with a positive gonorrhea/chlamydia (GC/CT) screen, a nucleic acid amplification test (NAAT) vaginal swab is the preferred specimen source, and self-collection is fine for women of any age, Dr. Policar said. In addition, cis-women who received anal intercourse in the preceding year should consider undergoing a rectal GC/CT NAAT, and those who performed oral sex should consider a pharyngeal GC/CT NAAT, based on shared clinical decision-making. A rectal swab requires an insertion of 3-4 cm and a 360-degree twirl of the wrist, not the swab, to ensure you get a sample from the entire circumference. Pharyngeal samples require swabbing both tonsillar pillars while taking care for those who may gag.
For contact testing – asymptomatic people who have had a high-risk sexual exposure – providers should test for gonorrhea, chlamydia, HIV, and syphilis but not for herpes, high-risk HPV, hepatitis B, hepatitis C, or bacterial vaginosis. “Maybe we’ll do a screen for trichomoniasis, and maybe we’ll offer herpes type 2 serology or antibody screening,” Dr. Policar said. Providers should also ask patients requesting contact testing if they have been vaccinated for hepatitis B. If not, “the conversation should be how can we get you vaccinated for hepatitis B,” Dr. Policar said.
HIV screening only needs to occur once between the ages of 15 and 65 for low-risk people and then once annually (or more often if necessary) for those who have a sex partner with HIV, use injectable drugs, engage in commercial sex work, have a new sex partner with unknown HIV status, received care at an STD or TB clinic, or were in a correctional facility or homeless shelter.
Those at increased risk for syphilis include men who have sex with men, men under age 29, and anyone living with HIV or who has a history of incarceration or a history of commercial sex work. In addition, African Americans have the greatest risk for syphilis of racial/ethnic groups, followed by Hispanics. Most adults only require hepatitis C screening with anti-hep C antibody testing once in their lifetime. Periodic hepatitis C screening should occur for people who inject drugs. If the screening is positive, providers should conduct an RNA polymerase chain reaction (PCR) test to determine whether a chronic infection is present.
Trichomoniasis screening should occur annually in women living with HIV or in correctional facilities. Others to consider screening include people with new or multiple sex partners, a history of STIs, inconsistent condom use, a history of sex work, and intravenous drug use. Dr. Policar also noted that several new assays, including NAAT, PCR, and a rapid test, are available for trichomoniasis.
STI treatment guidelines
For women with mucoprurulent cervicitis, the cause could be chlamydia, gonorrhea, herpes, trichomonas, mycoplasma, or even progesterone from pregnancy or contraception, Dr. Policar said. The new preferred treatment is 100 mg of doxycycline. The alternative, albeit less preferred, treatment is 1 g azithromycin.
The preferred treatment for chlamydia is now 100 mg oral doxycycline twice daily, or doxycycline 200 mg delayed-release once daily, for 7 days. Alternative regimens include 1 g oral azithromycin in a single dose or 500 mg oral levofloxacin once daily for 7 days. The switch to recommending doxycycline over azithromycin is based on recent evidence showing that doxycycline has a slightly higher efficacy for urogenital chlamydia and a substantially higher efficacy for rectal chlamydia. In addition, an increasing proportion of gonorrheal infections have shown resistance to azithromycin, particularly beginning in 2014.
Preferred treatment of new, uncomplicated gonorrhea infections of the cervix, urethra, rectum, and pharynx is one 500-mg dose of ceftriaxone for those weighing under 150 kg and 1 g for those weighing 150 kg or more. If ceftriaxone is unavailable, the new alternative recommended treatment for gonorrhea is 800 mg cefixime. For pharyngeal gonorrhea only, the CDC recommends a test-of-cure 7-14 days after treatment.
For gonorrheal infections, the CDC also recommends treatment with doxycycline if chlamydia has not been excluded, but the agency no longer recommends dual therapy with azithromycin unless it’s used in place of doxycycline for those who are pregnant, have an allergy, or may not be compliant with a 7-day doxycycline regimen.
The preferred treatment for bacterial vaginosis has not changed. The new recommended regimen for trichomoniasis is 500 mg oral metronidazole for 7 days, with the alternative being a single 2-g dose of tinidazole. Male partners should receive 2 g oral metronidazole. The CDC also notes that patients taking metronidazole no longer need to abstain from alcohol during treatment.
”Another area where the guidelines changed is in their description of expedited partner therapy, which means that, when we find an index case who has gonorrhea or chlamydia, we always have a discussion with her about getting her partners treated,” Dr. Policar said. “The CDC was quite clear that the responsibility for discussing partner treatment rests with us as the diagnosing provider” since city and county health departments don’t have the time or resources for contact tracing these STIs.
The two main ways to treat partners are to have the patient bring their partner(s) to the appointment with them or to do patient-delivered partner therapy. Ideally, clinicians who dispense their own medications can give the patient enough drugs to give her partner(s) a complete dose as well. Otherwise, providers can prescribe extra doses in the index patients’ name or write prescriptions in the partner’s name.
“In every state of the union now, it is legal for you to to prescribe antibiotics for partners sight unseen, Dr. Policar said.
Margaret Sullivan, MD, an ob.gyn. from rural western North Carolina, noted during the Q&A that an obstacle to partner therapy at her practice has been cost, particularly since many of the men don’t have insurance.
“I have not heard before of prescribing the extra doses for partners under the patient’s name,” Dr. Sullivan said. “I’ve thought about doing it, but [was worried about] it potentially being fraudulent if that patient has Medicaid and we’re prescribing extra doses under her name, so how do you work around that?”
Dr. Policar acknowledged that barrier and recommended that patients use the website/app Goodrx.com to find discounts for out-of-pocket generic medications. He also noted the occasional obstacle of pharmacists balking at filling a double or triple dose.
“What we’ve been suggesting in that circumstance is to literally copy that part of the CDC guidelines, which explains expedited partner therapy or patient-delivered partner therapy and send that off to the pharmacist so they can see that it’s a national recommendation of the CDC,” Dr. Policar said.
Claudia Rodriguez, MD, an ob.gyn. who works at Sherman Hospital in Elgin, Ill., asked about the CDC recommendations for HPV vaccination in older women. Although the CDC permits women over age 26 to receive the HPV vaccine, the agency does not “make a solid recommendation to have this done, which oftentimes makes a big difference in whether or not health insurance will actually pay for vaccination in that circumstance,” Dr. Policar said.
Patients are welcome to request the vaccine after shared decision-making, but “we should never present this as something which is routine,” he said. For women in their 50s, for example, “there’s virtually no data about any additional degree of protection that you would get” from HPV vaccination, Dr. Policar said in response to a similar question from Tara Allmen, MD, an ob.gyn. in New York City. “If you ask me for my personal clinical opinion about it, I would say it’s not going to be worth it,” he said.
Dr Policar had no disclosures. Disclosures were unavailable for attendees who spoke.
FROM NAMS 2021
Top questions answered about COVID-19 boosters for your patients
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Gastroenterology Data Trends 2021
Contents Include:
- Digital health in managing GI diseases
- Emergence of live biotherapeutic products for C. difficile and beyond
- AI and machine learning in GI practice
- Eosinophilic esophagitis: Addressing the rise in incidence and treatment options
- Racial and social diversity in GI practice
- The gut-brain connection in IBS
- Managing IBD in the backdrop of COVID-19
- Noncardia gastric cancer risk: Racial/ethnic disparity, gastric precancerous changes, and refractory H. pylori
- Rethinking management of alcohol-associated liver disease: The other fatty liver epidemic
- Endoscopic bariatric and metabolic therapies for weight loss
- The weight loss journey at University of Michigan
Contents Include:
- Digital health in managing GI diseases
- Emergence of live biotherapeutic products for C. difficile and beyond
- AI and machine learning in GI practice
- Eosinophilic esophagitis: Addressing the rise in incidence and treatment options
- Racial and social diversity in GI practice
- The gut-brain connection in IBS
- Managing IBD in the backdrop of COVID-19
- Noncardia gastric cancer risk: Racial/ethnic disparity, gastric precancerous changes, and refractory H. pylori
- Rethinking management of alcohol-associated liver disease: The other fatty liver epidemic
- Endoscopic bariatric and metabolic therapies for weight loss
- The weight loss journey at University of Michigan
Contents Include:
- Digital health in managing GI diseases
- Emergence of live biotherapeutic products for C. difficile and beyond
- AI and machine learning in GI practice
- Eosinophilic esophagitis: Addressing the rise in incidence and treatment options
- Racial and social diversity in GI practice
- The gut-brain connection in IBS
- Managing IBD in the backdrop of COVID-19
- Noncardia gastric cancer risk: Racial/ethnic disparity, gastric precancerous changes, and refractory H. pylori
- Rethinking management of alcohol-associated liver disease: The other fatty liver epidemic
- Endoscopic bariatric and metabolic therapies for weight loss
- The weight loss journey at University of Michigan
Bone density gains are lost following stop of denosumab in glucocorticoid-treated RA
Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.
That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.
“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.
Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.
The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.
Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”
Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).
“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.
“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.
However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.
Bone health after stopping denosumab
Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.
Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.
Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.
The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.
The patients had a mean age of 55, and 62% were women.
While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.
In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.
In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.
Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.
No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.
The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.
Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.
That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.
“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.
Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.
The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.
Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”
Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).
“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.
“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.
However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.
Bone health after stopping denosumab
Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.
Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.
Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.
The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.
The patients had a mean age of 55, and 62% were women.
While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.
In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.
In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.
Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.
No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.
The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.
Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.
That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.
“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.
Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.
The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.
Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”
Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).
“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.
“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.
However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.
Bone health after stopping denosumab
Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.
Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.
Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.
The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.
The patients had a mean age of 55, and 62% were women.
While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.
In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.
In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.
Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.
Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.
No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.
The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.
FROM ARTHRITIS & RHEUMATOLOGY