Cardiology News

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

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As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

The results were published online in the Journal of the American College of Cardiology.

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

What do you want to be when you grow up? What kind of doctor do you want to be? These are common conversation starters that we probably have all heard at some point in our lives.

But perhaps these are not the most thought-provoking or insightful questions to ask or be asked.

Instead, “What is your passion?” or “What inspires/motivates you?” or “What makes you want to get out of bed in the morning?” or “What creates flow for you?” may be more thoughtful questions that encourage greater self-reflection.

There is a Japanese concept called ikigai that loosely translates to “a reason for being.” This framework suggests that one should attempt to find the intersection of four things:

• One’s interests.
• One’s abilities/talents.
• What the world needs.
• What one can be paid for.

When any two of these intersect, you will have the following:

A passion: something that interests you and you excel at.

A profession: something that you excel at and are paid for.

A vocation: something that the world needs and that you’re paid for.

A mission: something that interests you and that the world needs.

Finding that “sweet spot” that intersects all four is the ideal prescribed by ikigai.

Ultimately, ikigai challenges us to find purpose, and finding this alignment of purpose can subsequently help us plan our professional and personal lives.

Of note, several of the world’s communities that are known for longevity/higher proportion of centenarians are linked by the common concept of ikigai. While there isn’t strong evidence that this phenomenon is correlated with or predictive of longevity, I believe we can all agree that finding purpose can lead to increased satisfaction, happiness, and perhaps less stress.

Achieving this sweet spot that satisfies all conditions above is undoubtedly easier said than done when placed in the context of real life, as there are often competing interests. Your purpose may align with a job that doesn’t pay the bills, or the job that provides financial stability may be uninteresting work to you. The path there may be winding, but eventually, with enough trial and error, I think we can all carve out a version of ikigai for ourselves.

I’ve had conversations with more senior physicians who have made a great impact in their fields and could certainly retire yesterday if they desired. When asked why they keep showing up, it is usually some version of “this is what I’m meant to do” or “this is my purpose” or “this is my joy.” In some ways, if you find true joy in what you do, it becomes part of your identity (in a positive way).

Though our health care system and culture are certainly far from perfect, many of us went to medical school because this was/is our “calling” – vocational, if you will. For me personally, it was a unique intersection of being able to serve others, use my abilities in math/science, and make a living.

In some ways, being a physician or health care worker puts us in a unique position to serve and provide services that the world needs. But with burnout rampant within the physician community, it is even more important to understand ourselves, work out our own version of ikigai, and make sure that we are living it daily.

Dr Thachil is a noninvasive cardiologist and assistant professor of medicine at the Albert Einstein College of Medicine, New York. She is a graduate of Jefferson Medical College and completed cardiology training at Mount Sinai Hospital. She is a fellow of the American College of Cardiology.

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

What do you want to be when you grow up? What kind of doctor do you want to be? These are common conversation starters that we probably have all heard at some point in our lives.

But perhaps these are not the most thought-provoking or insightful questions to ask or be asked.

Instead, “What is your passion?” or “What inspires/motivates you?” or “What makes you want to get out of bed in the morning?” or “What creates flow for you?” may be more thoughtful questions that encourage greater self-reflection.

There is a Japanese concept called ikigai that loosely translates to “a reason for being.” This framework suggests that one should attempt to find the intersection of four things:

• One’s interests.
• One’s abilities/talents.
• What the world needs.
• What one can be paid for.

When any two of these intersect, you will have the following:

A passion: something that interests you and you excel at.

A profession: something that you excel at and are paid for.

A vocation: something that the world needs and that you’re paid for.

A mission: something that interests you and that the world needs.

Finding that “sweet spot” that intersects all four is the ideal prescribed by ikigai.

Ultimately, ikigai challenges us to find purpose, and finding this alignment of purpose can subsequently help us plan our professional and personal lives.

Of note, several of the world’s communities that are known for longevity/higher proportion of centenarians are linked by the common concept of ikigai. While there isn’t strong evidence that this phenomenon is correlated with or predictive of longevity, I believe we can all agree that finding purpose can lead to increased satisfaction, happiness, and perhaps less stress.

Achieving this sweet spot that satisfies all conditions above is undoubtedly easier said than done when placed in the context of real life, as there are often competing interests. Your purpose may align with a job that doesn’t pay the bills, or the job that provides financial stability may be uninteresting work to you. The path there may be winding, but eventually, with enough trial and error, I think we can all carve out a version of ikigai for ourselves.

I’ve had conversations with more senior physicians who have made a great impact in their fields and could certainly retire yesterday if they desired. When asked why they keep showing up, it is usually some version of “this is what I’m meant to do” or “this is my purpose” or “this is my joy.” In some ways, if you find true joy in what you do, it becomes part of your identity (in a positive way).

Though our health care system and culture are certainly far from perfect, many of us went to medical school because this was/is our “calling” – vocational, if you will. For me personally, it was a unique intersection of being able to serve others, use my abilities in math/science, and make a living.

In some ways, being a physician or health care worker puts us in a unique position to serve and provide services that the world needs. But with burnout rampant within the physician community, it is even more important to understand ourselves, work out our own version of ikigai, and make sure that we are living it daily.

Dr Thachil is a noninvasive cardiologist and assistant professor of medicine at the Albert Einstein College of Medicine, New York. She is a graduate of Jefferson Medical College and completed cardiology training at Mount Sinai Hospital. She is a fellow of the American College of Cardiology.

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

What do you want to be when you grow up? What kind of doctor do you want to be? These are common conversation starters that we probably have all heard at some point in our lives.

But perhaps these are not the most thought-provoking or insightful questions to ask or be asked.

Instead, “What is your passion?” or “What inspires/motivates you?” or “What makes you want to get out of bed in the morning?” or “What creates flow for you?” may be more thoughtful questions that encourage greater self-reflection.

There is a Japanese concept called ikigai that loosely translates to “a reason for being.” This framework suggests that one should attempt to find the intersection of four things:

• One’s interests.
• One’s abilities/talents.
• What the world needs.
• What one can be paid for.

When any two of these intersect, you will have the following:

A passion: something that interests you and you excel at.

A profession: something that you excel at and are paid for.

A vocation: something that the world needs and that you’re paid for.

A mission: something that interests you and that the world needs.

Finding that “sweet spot” that intersects all four is the ideal prescribed by ikigai.

Ultimately, ikigai challenges us to find purpose, and finding this alignment of purpose can subsequently help us plan our professional and personal lives.

Of note, several of the world’s communities that are known for longevity/higher proportion of centenarians are linked by the common concept of ikigai. While there isn’t strong evidence that this phenomenon is correlated with or predictive of longevity, I believe we can all agree that finding purpose can lead to increased satisfaction, happiness, and perhaps less stress.

Achieving this sweet spot that satisfies all conditions above is undoubtedly easier said than done when placed in the context of real life, as there are often competing interests. Your purpose may align with a job that doesn’t pay the bills, or the job that provides financial stability may be uninteresting work to you. The path there may be winding, but eventually, with enough trial and error, I think we can all carve out a version of ikigai for ourselves.

I’ve had conversations with more senior physicians who have made a great impact in their fields and could certainly retire yesterday if they desired. When asked why they keep showing up, it is usually some version of “this is what I’m meant to do” or “this is my purpose” or “this is my joy.” In some ways, if you find true joy in what you do, it becomes part of your identity (in a positive way).

Though our health care system and culture are certainly far from perfect, many of us went to medical school because this was/is our “calling” – vocational, if you will. For me personally, it was a unique intersection of being able to serve others, use my abilities in math/science, and make a living.

In some ways, being a physician or health care worker puts us in a unique position to serve and provide services that the world needs. But with burnout rampant within the physician community, it is even more important to understand ourselves, work out our own version of ikigai, and make sure that we are living it daily.

Dr Thachil is a noninvasive cardiologist and assistant professor of medicine at the Albert Einstein College of Medicine, New York. She is a graduate of Jefferson Medical College and completed cardiology training at Mount Sinai Hospital. She is a fellow of the American College of Cardiology.

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

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Over the 10 years we’ve been writing this column, we have often found inspiration for topics while traveling – especially while flying. This is not just because of the idle time spent in the air, but instead because of the many ways that air travel and health care experiences are similar. Both industries focus heavily on safety, are tightly regulated, and employ highly trained individuals.

Consumers may recognize the similarities as well – health care and air travel are both well-known for long waits, uncertainty, and implicit risk. Both sectors are also notorious drivers of innovation, constantly leveraging new technologies in pursuit of better outcomes and experiences. Occasionally, however, advancements in technology can present unforeseen challenges and even compromise safety, with the potential to produce unexpected consequences.

A familiar reminder of this potential was provided to us at the commencement of a recent flight, when we were instructed to turn off our personal electronic devices or flip them into “airplane mode.” This same admonishment is often given to patients and visitors in health care settings – everywhere from clinic waiting rooms to intensive care units – though the reason for this is typically left vague. This got us thinking. We wondered, what is the real risk of smart phones in medicine , or aviation, for that matter. More importantly, what other emerging technologies have the potential to create issues we may not have anticipated?

Mayo Clinic findings on radio communication used by mobile phones

Once our flight landed, we did some research to answer our initial question about personal communication technology and its ability to interfere with sensitive electronic devices. Specifically, we wanted to know whether radio communication used by mobile phones could affect the operation of medical equipment, potentially leading to dire consequences for patients. Spoiler alert: There is very little evidence that this can occur. In fact, a well-documented study performed by the Mayo Clinic in 2007 found interference in 0 out of 300 tests performed. To quote the authors, “the incidence of clinically important interference was 0%.”

We could find no other studies since 2007 that strongly contradict Mayo’s findings, except for several anecdotal reports and articles that postulate the theoretical possibility.

This is confirmed by the American Heart Association, who maintains a list of devices that may interfere with ICDs and pacemakers on their website. According to the AHA, “wireless transmissions from the antennae of phones available in the United States are a very small risk to ICDs and even less of a risk for pacemakers.” And in case you’re wondering, the story is quite similar for airplanes as well.

The latest publication from NASA’s Aviation Safety Reporting System (ASRS) documents incidents related to personal electronic devices during air travel. Most involve smoke production – or even small fires – caused by malfunctioning phone batteries during charging. Only a few entries reference wireless interference, and these were all minor and unconfirmed events. As with health care environments, airplanes don’t appear to face significant risks from radio interference. But that doesn’t mean personal electronics are completely harmless to patients.

Smartphones’ risks to patient with cardiac devices

On May 13 of 2021, the FDA issued a warning to cardiac patients about their smart phones and smart watches. Many current personal electronic devices and accessories are equipped with strong magnets, such as those contained in the “MagSafe” connector on the iPhone 12, that can deactivate pacemakers and implanted cardiac defibrillators. These medical devices are designed to be manipulated by magnets for diagnostic and therapeutic purposes, but strong magnetic fields can disable them unintentionally, leading to catastrophic results.

Apple and other manufacturers have acknowledged this risk and recommend that smartphones and other devices be kept at least 6 inches from cardiac devices. Given the ubiquity of offending products, it is also imperative that we warn our patients about this risk to their physical wellbeing.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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