Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears (msears@mdedge.com) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears (msears@mdedge.com) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears (msears@mdedge.com) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

A scientific review by researchers in Spain confirms the negative influence of artificial sweeteners on several primary cardiovascular risk factors. It also shows evidence that these products are not beneficial for controlling excess weight. 

Francisco Gómez-Delgado, MD, PhD, and Pablo Pérez-Martínez, MD, PhD, are members of the Spanish Society of Arteriosclerosis and of the Spanish Society of Internal Medicine. They have coordinated an updated review of the leading scientific evidence surrounding artificial sweeteners: evidence showing that far from positively affecting our health, they have “negative effects for the cardiometabolic system.”

The paper, published in Current Opinion in Cardiology, delves into the consumption of these sweeteners and their negative influence on the development of obesity and of several of the most important cardiometabolic risk factors (hypertension, dyslipidemia, and diabetes).

Globalization and the increase in consumption of ultraprocessed foods have led to a need for greater knowledge on the health impacts of certain nutrients such as artificial sweeteners (nutritive and nonnutritive). This review aims to analyze their role and their effect on cardiometabolic and cardiovascular disease risk.
 

Cardiovascular risk

The detrimental effects of a high-calorie, high-sugar diet have been well established. For this reason, health authorities recommend limiting sugar consumption. The recommendation has led the food industry to develop different artificial sweeteners with specific properties, such as flavor and stability (nutritive artificial sweeteners), and others aimed at limiting sugar in the diet (nonnutritive artificial sweeteners). Recent evidence explores the influence of these two types of artificial sweeteners on cardiovascular disease risk through risk factors such as obesity and type 2 diabetes, among others.

Initially, the consumption of artificial sweeteners was presented as an alternative for reducing calorie intake in the diet as an option for people with excess weight and obesity. However, as this paper explains, the consumption of these artificial sweeteners favors weight gain because of neuroendocrine mechanisms related to satiety that are abnormally activated when artificial sweeteners are consumed.
 

Weight gain

On the other hand, evidence shows that consuming artificial sweeteners does not encourage weight loss. “Quite the contrary,” Dr. Pérez-Martínez, scientific director at the Maimonides Biomedical Research Institute and internist at the University Hospital Reina Sofia, both in Córdoba, told this news organization. “There is evidence showing weight gain resulting from the effect that artificial sweetener consumption has at the neurohormonal level by altering the mechanisms involved in regulating the feeling of satiety.”

However, on the basis of current evidence, sugar cannot be claimed to be less harmful. “What we do know is that in both cases, we should reduce or remove them from our diets and replace them with other healthier alternatives for weight management, such as eating plant-based products or being physically active.”
 

Confronting ignorance 

Nonetheless, these recommendations are conditional, “because the weight of the evidence is not extremely high, since there have not been a whole lot of studies. All nutritional studies must be viewed with caution,” Manuel Anguita, MD, PhD, said in an interview. Dr. Anguita is department head of clinical cardiology at the University Hospital Reina Sofia in Córdoba and past president of the Spanish Society of Cardiology.

“It’s something that should be included within the medical record when you’re assessing cardiovascular risk. In addition to identifying patients who use artificial sweeteners, it’s especially important to emphasize that it’s not an appropriate recommendation for weight management.” Healthier measures include moderate exercise and the Mediterranean diet.

Explaining why this research is valuable, he said, “It’s generally useful because there’s ignorance not only in the population but among physicians as well [about] these negative effects of sweeteners.”
 

Diabetes and metabolic syndrome

Artificial sweeteners cause significant disruptions in the endocrine system, leading our metabolism to function abnormally. The review revealed that consuming artificial sweeteners raises the risk for type 2 diabetes by between 18% and 24% and raises the risk for metabolic syndrome by up to 44%.

Dr. Gómez-Delgado, an internal medicine specialist at the University Hospital of Jaen in Spain and first author of the study, discussed the deleterious effects of sweeteners on metabolism. “On one hand, neurohormonal disorders impact appetite, and the feeling of satiety is abnormally delayed.” On the other hand, “they induce excessive insulin secretion in the pancreas,” which in the long run, encourages metabolic disorders that lead to diabetes. Ultimately, this process produces what we know as “dysbiosis, since our microbiota is unable to process these artificial sweeteners.” Dysbiosis triggers specific pathophysiologic processes that negatively affect cardiometabolic and cardiovascular systems.
 

No differences 

Regarding the type of sweetener, Dr. Gómez-Delgado noted that currently available studies assess the consumption of special dietary products that, in most cases, include various types of artificial sweeteners. “So, it’s not possible to define specific differences between them as to how they impact our health.” Additional studies are needed to confirm this effect at the cardiometabolic level and to analyze the different types of artificial sweeteners individually.

“There’s enough evidence to confirm that consuming artificial sweeteners negatively interferes with our metabolism – especially glucose metabolism – and increases the risk of developing diabetes,” said Dr. Gómez-Delgado.
 

High-sodium drinks

When it comes to the influence of artificial sweeteners on hypertension, “there is no single explanation. The World Health Organization already discussed this issue 4-5 years ago, not only due to their carcinogenic risk, but also due to this cardiovascular risk in terms of a lack of control of obesity, diabetes, and hypertension,” said Dr. Anguita.

Another important point “is that this is not in reference to the sweeteners themselves, but to soft drinks containing those components, which is where we have more studies,” he added. There are two factors explaining this increase in hypertension, which poses a problem at the population level, with medium- to long-term follow-up. “The sugary beverages that we mentioned have a higher sodium content. That is, the sweeteners add this element, which is a factor that’s directly linked to the increase in blood pressure levels.” Another factor that can influence blood pressure is “the increase in insulin secretion that has been described as resulting from sweeteners. In the medium and long term, this is associated with increased blood pressure levels.”
 

Cardiovascular risk factor?

Are artificial sweeteners considered to be a new cardiovascular risk factor? “What they really do is increase the incidence of the other classic risk factors,” including obesity, said Dr. Anguita. It has been shown that artificial sweeteners don’t reduce obesity when used continuously. Nonetheless, “there is still not enough evidence to view it in the same light as the classic risk factors,” added Dr. Anguita. However, it is a factor that can clearly worsen the control of the other factors. Therefore, “it’s appropriate to sound an alarm and explain that it’s not the best way to lose weight; there are many other healthier choices.”

“We need more robust evidence to take a clear position on the use of this type of sweetener and its detrimental effect on health. Meanwhile, it would be ideal to limit their consumption or even avoid adding artificial sweeteners to coffee or teas,” added Dr. Pérez-Martínez.
 

Regulate consumption 

Dr. Pérez-Martínez mentioned that the measures proposed to regulate the consumption of artificial sweeteners and to modify the current legislation must involve “minimizing the consumption of these special dietary products as much as possible and even avoiding adding these artificial sweeteners to the foods that we consume; for example, to coffee and tea.” On the other hand, “we must provide consumers with information that is as clear and simple as possible regarding the composition of the food they consume and how it impacts their health.”

However, “we need more evidence to be able to take a clear position on what type of sweeteners we can consume in our diet and also to what extent we should limit their presence in the foods we consume,” said Dr. Pérez-Martínez. 

Last, “most of the evidence is from short-term observational studies that assess frequencies and patterns of consumption of foods containing these artificial sweeteners.” Of course, “we need studies that specifically analyze their effects at the metabolic level as well as longer-term studies where the nutritional follow-up of participants is more accurate and rigorous, especially when it comes to the consumption of this type of food,” concluded Dr. Gómez-Delgado.

This article was translated from the Medscape Spanish Edition. A version appeared on Medscape.com.

A scientific review by researchers in Spain confirms the negative influence of artificial sweeteners on several primary cardiovascular risk factors. It also shows evidence that these products are not beneficial for controlling excess weight. 

Francisco Gómez-Delgado, MD, PhD, and Pablo Pérez-Martínez, MD, PhD, are members of the Spanish Society of Arteriosclerosis and of the Spanish Society of Internal Medicine. They have coordinated an updated review of the leading scientific evidence surrounding artificial sweeteners: evidence showing that far from positively affecting our health, they have “negative effects for the cardiometabolic system.”

The paper, published in Current Opinion in Cardiology, delves into the consumption of these sweeteners and their negative influence on the development of obesity and of several of the most important cardiometabolic risk factors (hypertension, dyslipidemia, and diabetes).

Globalization and the increase in consumption of ultraprocessed foods have led to a need for greater knowledge on the health impacts of certain nutrients such as artificial sweeteners (nutritive and nonnutritive). This review aims to analyze their role and their effect on cardiometabolic and cardiovascular disease risk.
 

Cardiovascular risk

The detrimental effects of a high-calorie, high-sugar diet have been well established. For this reason, health authorities recommend limiting sugar consumption. The recommendation has led the food industry to develop different artificial sweeteners with specific properties, such as flavor and stability (nutritive artificial sweeteners), and others aimed at limiting sugar in the diet (nonnutritive artificial sweeteners). Recent evidence explores the influence of these two types of artificial sweeteners on cardiovascular disease risk through risk factors such as obesity and type 2 diabetes, among others.

Initially, the consumption of artificial sweeteners was presented as an alternative for reducing calorie intake in the diet as an option for people with excess weight and obesity. However, as this paper explains, the consumption of these artificial sweeteners favors weight gain because of neuroendocrine mechanisms related to satiety that are abnormally activated when artificial sweeteners are consumed.
 

Weight gain

On the other hand, evidence shows that consuming artificial sweeteners does not encourage weight loss. “Quite the contrary,” Dr. Pérez-Martínez, scientific director at the Maimonides Biomedical Research Institute and internist at the University Hospital Reina Sofia, both in Córdoba, told this news organization. “There is evidence showing weight gain resulting from the effect that artificial sweetener consumption has at the neurohormonal level by altering the mechanisms involved in regulating the feeling of satiety.”

However, on the basis of current evidence, sugar cannot be claimed to be less harmful. “What we do know is that in both cases, we should reduce or remove them from our diets and replace them with other healthier alternatives for weight management, such as eating plant-based products or being physically active.”
 

Confronting ignorance 

Nonetheless, these recommendations are conditional, “because the weight of the evidence is not extremely high, since there have not been a whole lot of studies. All nutritional studies must be viewed with caution,” Manuel Anguita, MD, PhD, said in an interview. Dr. Anguita is department head of clinical cardiology at the University Hospital Reina Sofia in Córdoba and past president of the Spanish Society of Cardiology.

“It’s something that should be included within the medical record when you’re assessing cardiovascular risk. In addition to identifying patients who use artificial sweeteners, it’s especially important to emphasize that it’s not an appropriate recommendation for weight management.” Healthier measures include moderate exercise and the Mediterranean diet.

Explaining why this research is valuable, he said, “It’s generally useful because there’s ignorance not only in the population but among physicians as well [about] these negative effects of sweeteners.”
 

Diabetes and metabolic syndrome

Artificial sweeteners cause significant disruptions in the endocrine system, leading our metabolism to function abnormally. The review revealed that consuming artificial sweeteners raises the risk for type 2 diabetes by between 18% and 24% and raises the risk for metabolic syndrome by up to 44%.

Dr. Gómez-Delgado, an internal medicine specialist at the University Hospital of Jaen in Spain and first author of the study, discussed the deleterious effects of sweeteners on metabolism. “On one hand, neurohormonal disorders impact appetite, and the feeling of satiety is abnormally delayed.” On the other hand, “they induce excessive insulin secretion in the pancreas,” which in the long run, encourages metabolic disorders that lead to diabetes. Ultimately, this process produces what we know as “dysbiosis, since our microbiota is unable to process these artificial sweeteners.” Dysbiosis triggers specific pathophysiologic processes that negatively affect cardiometabolic and cardiovascular systems.
 

No differences 

Regarding the type of sweetener, Dr. Gómez-Delgado noted that currently available studies assess the consumption of special dietary products that, in most cases, include various types of artificial sweeteners. “So, it’s not possible to define specific differences between them as to how they impact our health.” Additional studies are needed to confirm this effect at the cardiometabolic level and to analyze the different types of artificial sweeteners individually.

“There’s enough evidence to confirm that consuming artificial sweeteners negatively interferes with our metabolism – especially glucose metabolism – and increases the risk of developing diabetes,” said Dr. Gómez-Delgado.
 

High-sodium drinks

When it comes to the influence of artificial sweeteners on hypertension, “there is no single explanation. The World Health Organization already discussed this issue 4-5 years ago, not only due to their carcinogenic risk, but also due to this cardiovascular risk in terms of a lack of control of obesity, diabetes, and hypertension,” said Dr. Anguita.

Another important point “is that this is not in reference to the sweeteners themselves, but to soft drinks containing those components, which is where we have more studies,” he added. There are two factors explaining this increase in hypertension, which poses a problem at the population level, with medium- to long-term follow-up. “The sugary beverages that we mentioned have a higher sodium content. That is, the sweeteners add this element, which is a factor that’s directly linked to the increase in blood pressure levels.” Another factor that can influence blood pressure is “the increase in insulin secretion that has been described as resulting from sweeteners. In the medium and long term, this is associated with increased blood pressure levels.”
 

Cardiovascular risk factor?

Are artificial sweeteners considered to be a new cardiovascular risk factor? “What they really do is increase the incidence of the other classic risk factors,” including obesity, said Dr. Anguita. It has been shown that artificial sweeteners don’t reduce obesity when used continuously. Nonetheless, “there is still not enough evidence to view it in the same light as the classic risk factors,” added Dr. Anguita. However, it is a factor that can clearly worsen the control of the other factors. Therefore, “it’s appropriate to sound an alarm and explain that it’s not the best way to lose weight; there are many other healthier choices.”

“We need more robust evidence to take a clear position on the use of this type of sweetener and its detrimental effect on health. Meanwhile, it would be ideal to limit their consumption or even avoid adding artificial sweeteners to coffee or teas,” added Dr. Pérez-Martínez.
 

Regulate consumption 

Dr. Pérez-Martínez mentioned that the measures proposed to regulate the consumption of artificial sweeteners and to modify the current legislation must involve “minimizing the consumption of these special dietary products as much as possible and even avoiding adding these artificial sweeteners to the foods that we consume; for example, to coffee and tea.” On the other hand, “we must provide consumers with information that is as clear and simple as possible regarding the composition of the food they consume and how it impacts their health.”

However, “we need more evidence to be able to take a clear position on what type of sweeteners we can consume in our diet and also to what extent we should limit their presence in the foods we consume,” said Dr. Pérez-Martínez. 

Last, “most of the evidence is from short-term observational studies that assess frequencies and patterns of consumption of foods containing these artificial sweeteners.” Of course, “we need studies that specifically analyze their effects at the metabolic level as well as longer-term studies where the nutritional follow-up of participants is more accurate and rigorous, especially when it comes to the consumption of this type of food,” concluded Dr. Gómez-Delgado.

This article was translated from the Medscape Spanish Edition. A version appeared on Medscape.com.

A scientific review by researchers in Spain confirms the negative influence of artificial sweeteners on several primary cardiovascular risk factors. It also shows evidence that these products are not beneficial for controlling excess weight. 

Francisco Gómez-Delgado, MD, PhD, and Pablo Pérez-Martínez, MD, PhD, are members of the Spanish Society of Arteriosclerosis and of the Spanish Society of Internal Medicine. They have coordinated an updated review of the leading scientific evidence surrounding artificial sweeteners: evidence showing that far from positively affecting our health, they have “negative effects for the cardiometabolic system.”

The paper, published in Current Opinion in Cardiology, delves into the consumption of these sweeteners and their negative influence on the development of obesity and of several of the most important cardiometabolic risk factors (hypertension, dyslipidemia, and diabetes).

Globalization and the increase in consumption of ultraprocessed foods have led to a need for greater knowledge on the health impacts of certain nutrients such as artificial sweeteners (nutritive and nonnutritive). This review aims to analyze their role and their effect on cardiometabolic and cardiovascular disease risk.
 

Cardiovascular risk

The detrimental effects of a high-calorie, high-sugar diet have been well established. For this reason, health authorities recommend limiting sugar consumption. The recommendation has led the food industry to develop different artificial sweeteners with specific properties, such as flavor and stability (nutritive artificial sweeteners), and others aimed at limiting sugar in the diet (nonnutritive artificial sweeteners). Recent evidence explores the influence of these two types of artificial sweeteners on cardiovascular disease risk through risk factors such as obesity and type 2 diabetes, among others.

Initially, the consumption of artificial sweeteners was presented as an alternative for reducing calorie intake in the diet as an option for people with excess weight and obesity. However, as this paper explains, the consumption of these artificial sweeteners favors weight gain because of neuroendocrine mechanisms related to satiety that are abnormally activated when artificial sweeteners are consumed.
 

Weight gain

On the other hand, evidence shows that consuming artificial sweeteners does not encourage weight loss. “Quite the contrary,” Dr. Pérez-Martínez, scientific director at the Maimonides Biomedical Research Institute and internist at the University Hospital Reina Sofia, both in Córdoba, told this news organization. “There is evidence showing weight gain resulting from the effect that artificial sweetener consumption has at the neurohormonal level by altering the mechanisms involved in regulating the feeling of satiety.”

However, on the basis of current evidence, sugar cannot be claimed to be less harmful. “What we do know is that in both cases, we should reduce or remove them from our diets and replace them with other healthier alternatives for weight management, such as eating plant-based products or being physically active.”
 

Confronting ignorance 

Nonetheless, these recommendations are conditional, “because the weight of the evidence is not extremely high, since there have not been a whole lot of studies. All nutritional studies must be viewed with caution,” Manuel Anguita, MD, PhD, said in an interview. Dr. Anguita is department head of clinical cardiology at the University Hospital Reina Sofia in Córdoba and past president of the Spanish Society of Cardiology.

“It’s something that should be included within the medical record when you’re assessing cardiovascular risk. In addition to identifying patients who use artificial sweeteners, it’s especially important to emphasize that it’s not an appropriate recommendation for weight management.” Healthier measures include moderate exercise and the Mediterranean diet.

Explaining why this research is valuable, he said, “It’s generally useful because there’s ignorance not only in the population but among physicians as well [about] these negative effects of sweeteners.”
 

Diabetes and metabolic syndrome

Artificial sweeteners cause significant disruptions in the endocrine system, leading our metabolism to function abnormally. The review revealed that consuming artificial sweeteners raises the risk for type 2 diabetes by between 18% and 24% and raises the risk for metabolic syndrome by up to 44%.

Dr. Gómez-Delgado, an internal medicine specialist at the University Hospital of Jaen in Spain and first author of the study, discussed the deleterious effects of sweeteners on metabolism. “On one hand, neurohormonal disorders impact appetite, and the feeling of satiety is abnormally delayed.” On the other hand, “they induce excessive insulin secretion in the pancreas,” which in the long run, encourages metabolic disorders that lead to diabetes. Ultimately, this process produces what we know as “dysbiosis, since our microbiota is unable to process these artificial sweeteners.” Dysbiosis triggers specific pathophysiologic processes that negatively affect cardiometabolic and cardiovascular systems.
 

No differences 

Regarding the type of sweetener, Dr. Gómez-Delgado noted that currently available studies assess the consumption of special dietary products that, in most cases, include various types of artificial sweeteners. “So, it’s not possible to define specific differences between them as to how they impact our health.” Additional studies are needed to confirm this effect at the cardiometabolic level and to analyze the different types of artificial sweeteners individually.

“There’s enough evidence to confirm that consuming artificial sweeteners negatively interferes with our metabolism – especially glucose metabolism – and increases the risk of developing diabetes,” said Dr. Gómez-Delgado.
 

High-sodium drinks

When it comes to the influence of artificial sweeteners on hypertension, “there is no single explanation. The World Health Organization already discussed this issue 4-5 years ago, not only due to their carcinogenic risk, but also due to this cardiovascular risk in terms of a lack of control of obesity, diabetes, and hypertension,” said Dr. Anguita.

Another important point “is that this is not in reference to the sweeteners themselves, but to soft drinks containing those components, which is where we have more studies,” he added. There are two factors explaining this increase in hypertension, which poses a problem at the population level, with medium- to long-term follow-up. “The sugary beverages that we mentioned have a higher sodium content. That is, the sweeteners add this element, which is a factor that’s directly linked to the increase in blood pressure levels.” Another factor that can influence blood pressure is “the increase in insulin secretion that has been described as resulting from sweeteners. In the medium and long term, this is associated with increased blood pressure levels.”
 

Cardiovascular risk factor?

Are artificial sweeteners considered to be a new cardiovascular risk factor? “What they really do is increase the incidence of the other classic risk factors,” including obesity, said Dr. Anguita. It has been shown that artificial sweeteners don’t reduce obesity when used continuously. Nonetheless, “there is still not enough evidence to view it in the same light as the classic risk factors,” added Dr. Anguita. However, it is a factor that can clearly worsen the control of the other factors. Therefore, “it’s appropriate to sound an alarm and explain that it’s not the best way to lose weight; there are many other healthier choices.”

“We need more robust evidence to take a clear position on the use of this type of sweetener and its detrimental effect on health. Meanwhile, it would be ideal to limit their consumption or even avoid adding artificial sweeteners to coffee or teas,” added Dr. Pérez-Martínez.
 

Regulate consumption 

Dr. Pérez-Martínez mentioned that the measures proposed to regulate the consumption of artificial sweeteners and to modify the current legislation must involve “minimizing the consumption of these special dietary products as much as possible and even avoiding adding these artificial sweeteners to the foods that we consume; for example, to coffee and tea.” On the other hand, “we must provide consumers with information that is as clear and simple as possible regarding the composition of the food they consume and how it impacts their health.”

However, “we need more evidence to be able to take a clear position on what type of sweeteners we can consume in our diet and also to what extent we should limit their presence in the foods we consume,” said Dr. Pérez-Martínez. 

Last, “most of the evidence is from short-term observational studies that assess frequencies and patterns of consumption of foods containing these artificial sweeteners.” Of course, “we need studies that specifically analyze their effects at the metabolic level as well as longer-term studies where the nutritional follow-up of participants is more accurate and rigorous, especially when it comes to the consumption of this type of food,” concluded Dr. Gómez-Delgado.

This article was translated from the Medscape Spanish Edition. A version appeared on Medscape.com.