A new Japanese study of highly purified eicosapentaenoic acid (EPA; icosapent ethyl) has suggested a possible benefit in reducing adverse cardiovascular events in patients with chronic coronary artery disease taking statins.

The open-label randomized RESPECT-EPA study showed a reduction of borderline statistical significance in its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina, and coronary revascularization in patients allocated to the EPA product at a dosage of 1,800 mg/day.

The results were presented at the American Heart Association scientific sessions by Hiroyuki Daida, MD, Juntendo University Graduate School of Medicine, Japan. 

However, the trial has several limitations, including a high number of patient withdrawals or protocol deviations, and as such, its conclusions are uncertain.  

Regardless, it has inevitably added to the debate on the cardiovascular benefits of EPA, which were shown in the REDUCE-IT trial. However, that trial has been dogged with controversy because of concerns that the mineral oil placebo used may have had an adverse effect.

Commenting on the new RESPECT-EPA trial for this article, lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, said the results were consistent with REDUCE-IT and another previous Japanese trial, the Japan EPA Lipid Intervention Study (JELIS), and added to the evidence supporting cardiovascular benefits of EPA.

“In isolation, this study may not be viewed as showing conclusive benefits, but looking at the totality of the data from this trial and from the field more widely, this together shows a convincing cardiovascular benefit with EPA,” Dr. Bhatt said. “We now have 3 randomized controlled trials all showing benefits of highly purified EPA in reducing cardiovascular events.”

However, long-time critic of the REDUCE-IT trial, Steve Nissen, MD, Cleveland Clinic, was not at all impressed with the RESPECT-EPA trial and does not believe it should be used to support the EPA data from REDUCE-IT. 

“The many limitations of the RESPECT-EPA trial make it uninterpretable. It just doesn’t meet contemporary standards for clinical trials,” Dr. Nissen said in an interview. “I don’t think it sheds any light at all on the debate over the efficacy of EPA in cardiovascular disease.”

Dr. Nissen was the lead investigator of another largescale trial, STRENGTH, which showed no benefit of a different high dose omega-3 fatty acid product including a combination of EPA and docosahexaenoic acid (DHA).  

In his AHA presentation on the RESPECT-EPA study, Dr. Daida explained as background that in 2005, JELIS first demonstrated a beneficial effect of highly purified EPA on cardiovascular outcomes in patients with and without coronary artery disease. 

Recently, optimal medical therapy, particularly with high-intensity statins, has become the gold standard of care for patients with coronary artery disease, but they are still at substantially high residual risk, he noted.

Despite of the evidence provided by JELIS, the conflicting results in recent omega-3 fatty acid trials (REDUCE-IT and STRENGTH) have led to an intense controversy regarding the relevance of EPA intervention on top of the latest optimal medical therapy, Dr. Daida said.

The current study – Randomized trial for Evaluating the Secondary Prevention Efficacy of Combination Therapy Statin and EPA (RESPECT-EPA) – was conducted to determine the effect of highly purified EPA on cardiovascular events in Japanese patients with chronic coronary artery disease and a low EPA/arachidonic acid (AA) ratio (< 0.4), who were already receiving statins.

They were randomly assigned to highly purified EPA (icosapent ethyl, 1,800 mg/day) plus statin therapy or to statin therapy alone.

The enrollment period started in 2013 and continued for 4 years. Patients were followed for a further 4 years from the end of the enrollment period.

The trial included 2,506 patients, 1,249 assigned to the EPA group and 1,257 to the control group. In both groups there were a high number of early withdrawals or protocol deviations (647 in the EPA group and 350 in the control group).

The analysis was conducted on 1,225 patients in the EPA group and 1,235 patients in the control group, although at 6 years’ follow-up there were fewer than 400 patients in each arm.  

Baseline characteristics showed median low-density lipoprotein (LDL) cholesterol levels of 80 mg/dL, EPA levels of 45 mcg/mL, and triglyceride levels of 120 mg/dL.

The primary endpoint, a composite of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, unstable angina, and coronary revascularization showed a borderline significant reduction in the EPA group at 6 years since the start of randomization (10.9% vs. 14.9%; hazard ratio, 0.785; P = .0547).

The secondary endpoint, a composite of sudden cardiac death, MI, unstable angina, and coronary revascularization, showed a significant reduction in the EPA group (8.0% vs. 11.3%; HR, 0.734; P = .0306).

In terms of adverse events, there was an increase in gastrointestinal disorders (3.4% vs. 1.2%) and new-onset atrial fibrillation (3.1% vs. 1.6%) in the EPA group.

In a post hoc analysis, which excluded patients with an increase of more than 30 mcg/mL in the control group (182 patients) and those with an increase of less than 30 mcg/mL in the EPA group (259 patients), the primary endpoint showed a significant reduction the EPA group (HR, 0.725; P = .0202).

Dr. Daida noted that limitations of the study included a lower than expected event rate (suggesting that the study may be underpowered), an open-label design, and the fact that baseline levels of EPA in this Japanese population would be higher than those in Western countries.
 

‘Massive loss’ of patients

Critiquing the study, Dr. Nissen highlighted the large dropout and protocol violation rate.

“There was a massive loss of patients over the 6- to 8-year follow-up, and the Kaplan-Meier curves didn’t start to diverge until after 4 years, by which time many patients had dropped out. It would have been a very selective population that lasted 6 years in the study. Patients that drop out are different to those that stay in, so they are cherry-picking the patients that persist in the trial. There is enormous bias here,” he commented. 

“Another weakness is the open-label design. Everyone knew who is getting what. Blinding is important in a study. And there was no control treatment in this trial,” he noted.

The researchers also selected patients with low EPA levels at baseline, Dr. Nissen added. “That is completely different hypothesis to what was tested in the REDUCE-IT and STRENGTH trials. And even with all these problems, the results are still statistically insignificant.”  

On the post hoc subgroup analysis showing a significant benefit, Dr. Nissen said, “they compared a subgroup in the active treatment arm who had large increases in EPA to a subgroup of control patients who had the smallest increase in EPA. That would be like comparing patients who had the largest reductions in LDL in a statin trial to those in the control arm who had no reductions or increases in LDL. That’s scientifically totally inappropriate.”
 

Supportive data

But Dr. Bhatt argues that the RESPECT-EPA trial supports the two previous trials showing benefits of EPA.

“Some may quibble with the P value, but to me this study has shown clear results, with obvious separation of the Kaplan-Meier curves,” he said.  

“It is an investigator-initiated study, which is good in principle but has some of the usual caveats of such a study in that – probably as a consequence of budget constraints – it has an open-label design and is underpowered. But as they did not use a placebo and still showed a benefit of EPA, that helps resolve the issue of the placebo used in REDUCE-IT for those who were concerned about it,” Dr. Bhatt noted.  

He pointed out that the 1,800-mg dose of EPA is the same dose used in the JELIS trial and is the dose used in Japan. The REDUCE-IT trial used a higher dose (4 g), but in general, Japanese people have higher levels of EPA than Western populations, he explained.  

“While this trial included patients with lower levels of EPA, what is considered low in Japan is much higher than average American levels,” he added.
 

Magnitude of benefit uncertain?

Discussant of the study at the Late Breaking Clinical Trials session, Pam R. Taub, MD, professor of medicine at the University of California, San Diego School of Medicine, said, “Despite being underpowered with a sample size of 2,460, RESPECT-EPA shows benefit in decreasing composite coronary events.”

“There is benefit with EPA, but the magnitude of benefit is uncertain,” she stated.

Dr. Taub pointed out that there is a signal across studies for new-onset atrial fibrillation, but the absolute increase is “rather small.”

She noted that more mechanistic and clinical data are needed to hone in on which patients will derive the most benefit, such as those with elevated high-sensitivity C-reactive protein or highest change in EPA levels. But she concluded that in clinical practice, physicians could consider addition of EPA for reduction of residual risk in secondary prevention patients.

The RESPECT-EPA study was supported by the Japan Heart Foundation. Dr. Daida reports peakers’ bureau/honorarium fees from Novartis Pharma, Bayer Yakuhin, Sanofi, Kowa Company, Taisho Pharmaceutical, Abbott Medical Japan, Otsuka Pharmaceutical, Amgen, MSD, Daiichi Sankyo, Pfizer Japan, FUKUDA DENSHI, Tsumura, and TOA EIYO and research funding from Philips Japan, FUJIFILM Holdings, Asahi Kasei, Inter Reha, TOHO HOLDINGS, GLORY, BMS, Abbott Japan, and Boehringer Ingelheim Japan.

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

A new Japanese study of highly purified eicosapentaenoic acid (EPA; icosapent ethyl) has suggested a possible benefit in reducing adverse cardiovascular events in patients with chronic coronary artery disease taking statins.

The open-label randomized RESPECT-EPA study showed a reduction of borderline statistical significance in its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina, and coronary revascularization in patients allocated to the EPA product at a dosage of 1,800 mg/day.

The results were presented at the American Heart Association scientific sessions by Hiroyuki Daida, MD, Juntendo University Graduate School of Medicine, Japan. 

However, the trial has several limitations, including a high number of patient withdrawals or protocol deviations, and as such, its conclusions are uncertain.  

Regardless, it has inevitably added to the debate on the cardiovascular benefits of EPA, which were shown in the REDUCE-IT trial. However, that trial has been dogged with controversy because of concerns that the mineral oil placebo used may have had an adverse effect.

Commenting on the new RESPECT-EPA trial for this article, lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, said the results were consistent with REDUCE-IT and another previous Japanese trial, the Japan EPA Lipid Intervention Study (JELIS), and added to the evidence supporting cardiovascular benefits of EPA.

“In isolation, this study may not be viewed as showing conclusive benefits, but looking at the totality of the data from this trial and from the field more widely, this together shows a convincing cardiovascular benefit with EPA,” Dr. Bhatt said. “We now have 3 randomized controlled trials all showing benefits of highly purified EPA in reducing cardiovascular events.”

However, long-time critic of the REDUCE-IT trial, Steve Nissen, MD, Cleveland Clinic, was not at all impressed with the RESPECT-EPA trial and does not believe it should be used to support the EPA data from REDUCE-IT. 

“The many limitations of the RESPECT-EPA trial make it uninterpretable. It just doesn’t meet contemporary standards for clinical trials,” Dr. Nissen said in an interview. “I don’t think it sheds any light at all on the debate over the efficacy of EPA in cardiovascular disease.”

Dr. Nissen was the lead investigator of another largescale trial, STRENGTH, which showed no benefit of a different high dose omega-3 fatty acid product including a combination of EPA and docosahexaenoic acid (DHA).  

In his AHA presentation on the RESPECT-EPA study, Dr. Daida explained as background that in 2005, JELIS first demonstrated a beneficial effect of highly purified EPA on cardiovascular outcomes in patients with and without coronary artery disease. 

Recently, optimal medical therapy, particularly with high-intensity statins, has become the gold standard of care for patients with coronary artery disease, but they are still at substantially high residual risk, he noted.

Despite of the evidence provided by JELIS, the conflicting results in recent omega-3 fatty acid trials (REDUCE-IT and STRENGTH) have led to an intense controversy regarding the relevance of EPA intervention on top of the latest optimal medical therapy, Dr. Daida said.

The current study – Randomized trial for Evaluating the Secondary Prevention Efficacy of Combination Therapy Statin and EPA (RESPECT-EPA) – was conducted to determine the effect of highly purified EPA on cardiovascular events in Japanese patients with chronic coronary artery disease and a low EPA/arachidonic acid (AA) ratio (< 0.4), who were already receiving statins.

They were randomly assigned to highly purified EPA (icosapent ethyl, 1,800 mg/day) plus statin therapy or to statin therapy alone.

The enrollment period started in 2013 and continued for 4 years. Patients were followed for a further 4 years from the end of the enrollment period.

The trial included 2,506 patients, 1,249 assigned to the EPA group and 1,257 to the control group. In both groups there were a high number of early withdrawals or protocol deviations (647 in the EPA group and 350 in the control group).

The analysis was conducted on 1,225 patients in the EPA group and 1,235 patients in the control group, although at 6 years’ follow-up there were fewer than 400 patients in each arm.  

Baseline characteristics showed median low-density lipoprotein (LDL) cholesterol levels of 80 mg/dL, EPA levels of 45 mcg/mL, and triglyceride levels of 120 mg/dL.

The primary endpoint, a composite of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, unstable angina, and coronary revascularization showed a borderline significant reduction in the EPA group at 6 years since the start of randomization (10.9% vs. 14.9%; hazard ratio, 0.785; P = .0547).

The secondary endpoint, a composite of sudden cardiac death, MI, unstable angina, and coronary revascularization, showed a significant reduction in the EPA group (8.0% vs. 11.3%; HR, 0.734; P = .0306).

In terms of adverse events, there was an increase in gastrointestinal disorders (3.4% vs. 1.2%) and new-onset atrial fibrillation (3.1% vs. 1.6%) in the EPA group.

In a post hoc analysis, which excluded patients with an increase of more than 30 mcg/mL in the control group (182 patients) and those with an increase of less than 30 mcg/mL in the EPA group (259 patients), the primary endpoint showed a significant reduction the EPA group (HR, 0.725; P = .0202).

Dr. Daida noted that limitations of the study included a lower than expected event rate (suggesting that the study may be underpowered), an open-label design, and the fact that baseline levels of EPA in this Japanese population would be higher than those in Western countries.
 

‘Massive loss’ of patients

Critiquing the study, Dr. Nissen highlighted the large dropout and protocol violation rate.

“There was a massive loss of patients over the 6- to 8-year follow-up, and the Kaplan-Meier curves didn’t start to diverge until after 4 years, by which time many patients had dropped out. It would have been a very selective population that lasted 6 years in the study. Patients that drop out are different to those that stay in, so they are cherry-picking the patients that persist in the trial. There is enormous bias here,” he commented. 

“Another weakness is the open-label design. Everyone knew who is getting what. Blinding is important in a study. And there was no control treatment in this trial,” he noted.

The researchers also selected patients with low EPA levels at baseline, Dr. Nissen added. “That is completely different hypothesis to what was tested in the REDUCE-IT and STRENGTH trials. And even with all these problems, the results are still statistically insignificant.”  

On the post hoc subgroup analysis showing a significant benefit, Dr. Nissen said, “they compared a subgroup in the active treatment arm who had large increases in EPA to a subgroup of control patients who had the smallest increase in EPA. That would be like comparing patients who had the largest reductions in LDL in a statin trial to those in the control arm who had no reductions or increases in LDL. That’s scientifically totally inappropriate.”
 

Supportive data

But Dr. Bhatt argues that the RESPECT-EPA trial supports the two previous trials showing benefits of EPA.

“Some may quibble with the P value, but to me this study has shown clear results, with obvious separation of the Kaplan-Meier curves,” he said.  

“It is an investigator-initiated study, which is good in principle but has some of the usual caveats of such a study in that – probably as a consequence of budget constraints – it has an open-label design and is underpowered. But as they did not use a placebo and still showed a benefit of EPA, that helps resolve the issue of the placebo used in REDUCE-IT for those who were concerned about it,” Dr. Bhatt noted.  

He pointed out that the 1,800-mg dose of EPA is the same dose used in the JELIS trial and is the dose used in Japan. The REDUCE-IT trial used a higher dose (4 g), but in general, Japanese people have higher levels of EPA than Western populations, he explained.  

“While this trial included patients with lower levels of EPA, what is considered low in Japan is much higher than average American levels,” he added.
 

Magnitude of benefit uncertain?

Discussant of the study at the Late Breaking Clinical Trials session, Pam R. Taub, MD, professor of medicine at the University of California, San Diego School of Medicine, said, “Despite being underpowered with a sample size of 2,460, RESPECT-EPA shows benefit in decreasing composite coronary events.”

“There is benefit with EPA, but the magnitude of benefit is uncertain,” she stated.

Dr. Taub pointed out that there is a signal across studies for new-onset atrial fibrillation, but the absolute increase is “rather small.”

She noted that more mechanistic and clinical data are needed to hone in on which patients will derive the most benefit, such as those with elevated high-sensitivity C-reactive protein or highest change in EPA levels. But she concluded that in clinical practice, physicians could consider addition of EPA for reduction of residual risk in secondary prevention patients.

The RESPECT-EPA study was supported by the Japan Heart Foundation. Dr. Daida reports peakers’ bureau/honorarium fees from Novartis Pharma, Bayer Yakuhin, Sanofi, Kowa Company, Taisho Pharmaceutical, Abbott Medical Japan, Otsuka Pharmaceutical, Amgen, MSD, Daiichi Sankyo, Pfizer Japan, FUKUDA DENSHI, Tsumura, and TOA EIYO and research funding from Philips Japan, FUJIFILM Holdings, Asahi Kasei, Inter Reha, TOHO HOLDINGS, GLORY, BMS, Abbott Japan, and Boehringer Ingelheim Japan.

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

A new Japanese study of highly purified eicosapentaenoic acid (EPA; icosapent ethyl) has suggested a possible benefit in reducing adverse cardiovascular events in patients with chronic coronary artery disease taking statins.

The open-label randomized RESPECT-EPA study showed a reduction of borderline statistical significance in its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina, and coronary revascularization in patients allocated to the EPA product at a dosage of 1,800 mg/day.

The results were presented at the American Heart Association scientific sessions by Hiroyuki Daida, MD, Juntendo University Graduate School of Medicine, Japan. 

However, the trial has several limitations, including a high number of patient withdrawals or protocol deviations, and as such, its conclusions are uncertain.  

Regardless, it has inevitably added to the debate on the cardiovascular benefits of EPA, which were shown in the REDUCE-IT trial. However, that trial has been dogged with controversy because of concerns that the mineral oil placebo used may have had an adverse effect.

Commenting on the new RESPECT-EPA trial for this article, lead investigator of the REDUCE-IT trial, Deepak Bhatt, MD, said the results were consistent with REDUCE-IT and another previous Japanese trial, the Japan EPA Lipid Intervention Study (JELIS), and added to the evidence supporting cardiovascular benefits of EPA.

“In isolation, this study may not be viewed as showing conclusive benefits, but looking at the totality of the data from this trial and from the field more widely, this together shows a convincing cardiovascular benefit with EPA,” Dr. Bhatt said. “We now have 3 randomized controlled trials all showing benefits of highly purified EPA in reducing cardiovascular events.”

However, long-time critic of the REDUCE-IT trial, Steve Nissen, MD, Cleveland Clinic, was not at all impressed with the RESPECT-EPA trial and does not believe it should be used to support the EPA data from REDUCE-IT. 

“The many limitations of the RESPECT-EPA trial make it uninterpretable. It just doesn’t meet contemporary standards for clinical trials,” Dr. Nissen said in an interview. “I don’t think it sheds any light at all on the debate over the efficacy of EPA in cardiovascular disease.”

Dr. Nissen was the lead investigator of another largescale trial, STRENGTH, which showed no benefit of a different high dose omega-3 fatty acid product including a combination of EPA and docosahexaenoic acid (DHA).  

In his AHA presentation on the RESPECT-EPA study, Dr. Daida explained as background that in 2005, JELIS first demonstrated a beneficial effect of highly purified EPA on cardiovascular outcomes in patients with and without coronary artery disease. 

Recently, optimal medical therapy, particularly with high-intensity statins, has become the gold standard of care for patients with coronary artery disease, but they are still at substantially high residual risk, he noted.

Despite of the evidence provided by JELIS, the conflicting results in recent omega-3 fatty acid trials (REDUCE-IT and STRENGTH) have led to an intense controversy regarding the relevance of EPA intervention on top of the latest optimal medical therapy, Dr. Daida said.

The current study – Randomized trial for Evaluating the Secondary Prevention Efficacy of Combination Therapy Statin and EPA (RESPECT-EPA) – was conducted to determine the effect of highly purified EPA on cardiovascular events in Japanese patients with chronic coronary artery disease and a low EPA/arachidonic acid (AA) ratio (< 0.4), who were already receiving statins.

They were randomly assigned to highly purified EPA (icosapent ethyl, 1,800 mg/day) plus statin therapy or to statin therapy alone.

The enrollment period started in 2013 and continued for 4 years. Patients were followed for a further 4 years from the end of the enrollment period.

The trial included 2,506 patients, 1,249 assigned to the EPA group and 1,257 to the control group. In both groups there were a high number of early withdrawals or protocol deviations (647 in the EPA group and 350 in the control group).

The analysis was conducted on 1,225 patients in the EPA group and 1,235 patients in the control group, although at 6 years’ follow-up there were fewer than 400 patients in each arm.  

Baseline characteristics showed median low-density lipoprotein (LDL) cholesterol levels of 80 mg/dL, EPA levels of 45 mcg/mL, and triglyceride levels of 120 mg/dL.

The primary endpoint, a composite of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, unstable angina, and coronary revascularization showed a borderline significant reduction in the EPA group at 6 years since the start of randomization (10.9% vs. 14.9%; hazard ratio, 0.785; P = .0547).

The secondary endpoint, a composite of sudden cardiac death, MI, unstable angina, and coronary revascularization, showed a significant reduction in the EPA group (8.0% vs. 11.3%; HR, 0.734; P = .0306).

In terms of adverse events, there was an increase in gastrointestinal disorders (3.4% vs. 1.2%) and new-onset atrial fibrillation (3.1% vs. 1.6%) in the EPA group.

In a post hoc analysis, which excluded patients with an increase of more than 30 mcg/mL in the control group (182 patients) and those with an increase of less than 30 mcg/mL in the EPA group (259 patients), the primary endpoint showed a significant reduction the EPA group (HR, 0.725; P = .0202).

Dr. Daida noted that limitations of the study included a lower than expected event rate (suggesting that the study may be underpowered), an open-label design, and the fact that baseline levels of EPA in this Japanese population would be higher than those in Western countries.
 

‘Massive loss’ of patients

Critiquing the study, Dr. Nissen highlighted the large dropout and protocol violation rate.

“There was a massive loss of patients over the 6- to 8-year follow-up, and the Kaplan-Meier curves didn’t start to diverge until after 4 years, by which time many patients had dropped out. It would have been a very selective population that lasted 6 years in the study. Patients that drop out are different to those that stay in, so they are cherry-picking the patients that persist in the trial. There is enormous bias here,” he commented. 

“Another weakness is the open-label design. Everyone knew who is getting what. Blinding is important in a study. And there was no control treatment in this trial,” he noted.

The researchers also selected patients with low EPA levels at baseline, Dr. Nissen added. “That is completely different hypothesis to what was tested in the REDUCE-IT and STRENGTH trials. And even with all these problems, the results are still statistically insignificant.”  

On the post hoc subgroup analysis showing a significant benefit, Dr. Nissen said, “they compared a subgroup in the active treatment arm who had large increases in EPA to a subgroup of control patients who had the smallest increase in EPA. That would be like comparing patients who had the largest reductions in LDL in a statin trial to those in the control arm who had no reductions or increases in LDL. That’s scientifically totally inappropriate.”
 

Supportive data

But Dr. Bhatt argues that the RESPECT-EPA trial supports the two previous trials showing benefits of EPA.

“Some may quibble with the P value, but to me this study has shown clear results, with obvious separation of the Kaplan-Meier curves,” he said.  

“It is an investigator-initiated study, which is good in principle but has some of the usual caveats of such a study in that – probably as a consequence of budget constraints – it has an open-label design and is underpowered. But as they did not use a placebo and still showed a benefit of EPA, that helps resolve the issue of the placebo used in REDUCE-IT for those who were concerned about it,” Dr. Bhatt noted.  

He pointed out that the 1,800-mg dose of EPA is the same dose used in the JELIS trial and is the dose used in Japan. The REDUCE-IT trial used a higher dose (4 g), but in general, Japanese people have higher levels of EPA than Western populations, he explained.  

“While this trial included patients with lower levels of EPA, what is considered low in Japan is much higher than average American levels,” he added.
 

Magnitude of benefit uncertain?

Discussant of the study at the Late Breaking Clinical Trials session, Pam R. Taub, MD, professor of medicine at the University of California, San Diego School of Medicine, said, “Despite being underpowered with a sample size of 2,460, RESPECT-EPA shows benefit in decreasing composite coronary events.”

“There is benefit with EPA, but the magnitude of benefit is uncertain,” she stated.

Dr. Taub pointed out that there is a signal across studies for new-onset atrial fibrillation, but the absolute increase is “rather small.”

She noted that more mechanistic and clinical data are needed to hone in on which patients will derive the most benefit, such as those with elevated high-sensitivity C-reactive protein or highest change in EPA levels. But she concluded that in clinical practice, physicians could consider addition of EPA for reduction of residual risk in secondary prevention patients.

The RESPECT-EPA study was supported by the Japan Heart Foundation. Dr. Daida reports peakers’ bureau/honorarium fees from Novartis Pharma, Bayer Yakuhin, Sanofi, Kowa Company, Taisho Pharmaceutical, Abbott Medical Japan, Otsuka Pharmaceutical, Amgen, MSD, Daiichi Sankyo, Pfizer Japan, FUKUDA DENSHI, Tsumura, and TOA EIYO and research funding from Philips Japan, FUJIFILM Holdings, Asahi Kasei, Inter Reha, TOHO HOLDINGS, GLORY, BMS, Abbott Japan, and Boehringer Ingelheim Japan.

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

CHICAGO – The traditional Chinese herbal medicine tongxinluo added to guideline-directed therapy improves clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI), the CTS-AMI study suggests.

Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.

Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.

The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.

He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”

Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.

The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.

In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.

The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).

Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).

Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.

The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.

At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.

At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).

In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).

Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.

“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.

Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”

Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”

Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.

“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”

He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.

“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.

Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”

The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.

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

CHICAGO – The traditional Chinese herbal medicine tongxinluo added to guideline-directed therapy improves clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI), the CTS-AMI study suggests.

Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.

Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.

The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.

He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”

Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.

The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.

In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.

The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).

Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).

Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.

The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.

At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.

At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).

In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).

Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.

“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.

Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”

Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”

Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.

“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”

He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.

“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.

Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”

The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.

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

CHICAGO – The traditional Chinese herbal medicine tongxinluo added to guideline-directed therapy improves clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI), the CTS-AMI study suggests.

Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.

Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.

The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.

He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”

Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.

The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.

In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.

The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).

Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).

Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.

The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.

At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.

At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).

In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).

Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.

“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.

Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”

Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”

Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.

“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”

He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.

“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.

Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”

The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.

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

The 2022 CHEST Annual Meeting had several important studies on lung cancer.

Douglas Arenberg, MD, FCCP from the University of Michigan Northville Health Center, reports on content from two papers that focus on the first million persons to have been screened for lung cancer after the initial launch of the American College of Radiology Lung Cancer Screening Registry. The research showed that the medical community is, in fact, doing well in some areas of lung cancer screening but that improvements need to be made in order to reach former tobacco users, who would greatly benefit from these screenings. 

He also highlights a series of studies that were discussed regarding smoking cessation at lung evaluations known as the SCALE Collaboration. Effective smoking interventions could enhance the benefits of lung cancer screening by reducing mortality and morbidity resulting from lung cancer.

Finally, Dr Arenberg shares a series of presentations that highlight how the surgical treatment of early-stage lung cancer is creating significant changes in the standard of care.

--

Douglas Arenberg, MD, FCCP Professor of Medicine, Department of Internal Medicine, Division of Pulmonary & Critical Care, University of Michigan; Director of Bronchoscopy and Medical Director for the Lung Cancer Screening and Lung Nodule Clinics, University of Michigan, Ann Arbor, Michigan 

Douglas Arenberg, MD, FCCP has disclosed no relevant financial relationships. 

The 2022 CHEST Annual Meeting had several important studies on lung cancer.

Douglas Arenberg, MD, FCCP from the University of Michigan Northville Health Center, reports on content from two papers that focus on the first million persons to have been screened for lung cancer after the initial launch of the American College of Radiology Lung Cancer Screening Registry. The research showed that the medical community is, in fact, doing well in some areas of lung cancer screening but that improvements need to be made in order to reach former tobacco users, who would greatly benefit from these screenings. 

He also highlights a series of studies that were discussed regarding smoking cessation at lung evaluations known as the SCALE Collaboration. Effective smoking interventions could enhance the benefits of lung cancer screening by reducing mortality and morbidity resulting from lung cancer.

Finally, Dr Arenberg shares a series of presentations that highlight how the surgical treatment of early-stage lung cancer is creating significant changes in the standard of care.

--

Douglas Arenberg, MD, FCCP Professor of Medicine, Department of Internal Medicine, Division of Pulmonary & Critical Care, University of Michigan; Director of Bronchoscopy and Medical Director for the Lung Cancer Screening and Lung Nodule Clinics, University of Michigan, Ann Arbor, Michigan 

Douglas Arenberg, MD, FCCP has disclosed no relevant financial relationships. 

The 2022 CHEST Annual Meeting had several important studies on lung cancer.

Douglas Arenberg, MD, FCCP from the University of Michigan Northville Health Center, reports on content from two papers that focus on the first million persons to have been screened for lung cancer after the initial launch of the American College of Radiology Lung Cancer Screening Registry. The research showed that the medical community is, in fact, doing well in some areas of lung cancer screening but that improvements need to be made in order to reach former tobacco users, who would greatly benefit from these screenings. 

He also highlights a series of studies that were discussed regarding smoking cessation at lung evaluations known as the SCALE Collaboration. Effective smoking interventions could enhance the benefits of lung cancer screening by reducing mortality and morbidity resulting from lung cancer.

Finally, Dr Arenberg shares a series of presentations that highlight how the surgical treatment of early-stage lung cancer is creating significant changes in the standard of care.

--

Douglas Arenberg, MD, FCCP Professor of Medicine, Department of Internal Medicine, Division of Pulmonary & Critical Care, University of Michigan; Director of Bronchoscopy and Medical Director for the Lung Cancer Screening and Lung Nodule Clinics, University of Michigan, Ann Arbor, Michigan 

Douglas Arenberg, MD, FCCP has disclosed no relevant financial relationships. 

Noninvasive ultrasound- and serum-based fibrosis biomarkers have similar prognostic performance to histology for nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Fibrosis stages and liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE) through FibroScan were significant predictors of event-free survival, said Ferenc Mozes, DPhil, a postdoctoral research assistant at the University of Oxford, England, who has worked on biomarker evaluation of nonalcoholic steatohepatitis (NASH) as a member of the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) consortium.

“Liver histology is highly prognostic of liver-related outcomes in patients with NAFLD and NASH,” he said. “Not just that, but liver histology is also accepted, and furthermore mandated by the FDA, as a surrogate endpoint in pharmaceutical trials for NASH.”

Noninvasive ultrasound- and serum-based fibrosis biomarkers have similar prognostic performance to histology for nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Fibrosis stages and liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE) through FibroScan were significant predictors of event-free survival, said Ferenc Mozes, DPhil, a postdoctoral research assistant at the University of Oxford, England, who has worked on biomarker evaluation of nonalcoholic steatohepatitis (NASH) as a member of the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) consortium.

“Liver histology is highly prognostic of liver-related outcomes in patients with NAFLD and NASH,” he said. “Not just that, but liver histology is also accepted, and furthermore mandated by the FDA, as a surrogate endpoint in pharmaceutical trials for NASH.”

Noninvasive ultrasound- and serum-based fibrosis biomarkers have similar prognostic performance to histology for nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Fibrosis stages and liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE) through FibroScan were significant predictors of event-free survival, said Ferenc Mozes, DPhil, a postdoctoral research assistant at the University of Oxford, England, who has worked on biomarker evaluation of nonalcoholic steatohepatitis (NASH) as a member of the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) consortium.

“Liver histology is highly prognostic of liver-related outcomes in patients with NAFLD and NASH,” he said. “Not just that, but liver histology is also accepted, and furthermore mandated by the FDA, as a surrogate endpoint in pharmaceutical trials for NASH.”

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

Response-adapted de-escalation of immunotherapy in patients with advanced melanoma may lead to considerable savings for payers – close to $20,000 per patient – compared with standard immunotherapy, an economic analysis found.

“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.

This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.

The study was published online in JAMA Dermatology.

While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.

One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.

In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.

The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.

Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.

The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.

Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.

When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.

“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.

“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”

When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”

However, Dr. Skitzki said several caveats need to be considered.

One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.

“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.

A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.

Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.

“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”

Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”

This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.

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

Response-adapted de-escalation of immunotherapy in patients with advanced melanoma may lead to considerable savings for payers – close to $20,000 per patient – compared with standard immunotherapy, an economic analysis found.

“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.

This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.

The study was published online in JAMA Dermatology.

While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.

One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.

In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.

The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.

Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.

The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.

Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.

When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.

“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.

“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”

When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”

However, Dr. Skitzki said several caveats need to be considered.

One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.

“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.

A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.

Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.

“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”

Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”

This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.

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

Response-adapted de-escalation of immunotherapy in patients with advanced melanoma may lead to considerable savings for payers – close to $20,000 per patient – compared with standard immunotherapy, an economic analysis found.

“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.

This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.

The study was published online in JAMA Dermatology.

While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.

One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.

In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.

The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.

Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.

The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.

Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.

When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.

“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.

“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”

When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”

However, Dr. Skitzki said several caveats need to be considered.

One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.

“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.

A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.

Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.

“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”

Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”

This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.

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

CHICAGO – A stepwise care pathway was associated with a substantial reduction in the number of invasive tests performed and a major improvement in outcomes, relative to usual management, in patients suspected of coronary artery disease (CAD), according to 1-year results of the multinational, randomized PRECISE trial.

The care pathway is appropriate for patients with nonacute chest pain or equivalent complaints that have raised suspicion of CAD, and it is extremely simple, according to the description from the principal investigator, Pamela S. Douglas, MD, given in her presentation at the annual scientific sessions of the American Heart Association.

Ted Bosworth/MDedge News

Unlike the highly complex diagnostic algorithms shunting suspected CAD patients to the vast array of potential evaluations, the newly tested protocol, characterized as a “precision strategy,” divides patients into those who are immediate candidates for invasive testing and those who are not. The discriminator is the PROMISE minimal risk assessment score, a tool already validated.

Those deemed candidates for testing on the basis of an elevated score undergo computed coronary CT angiography (cCTA). In those who are not, testing is deferred.
 

Strategy is simple but effective

Although simple, this pathway is highly effective, judging by the results of the PRECISE trial, which tested the strategy in 2,103 patients at 65 sites in North America and Europe. The primary outcome was a composite of major adverse cardiovascular events (MACE) that included death, nonfatal MI, and catheterization without observed CAD.

After a median follow-up of 11.8 months, the primary MACE endpoint was reached in about 11.3% of those in the usual-care group, which was more than twofold higher than the 4.2% in the precision strategy group. The unadjusted risk reduction was 65% but rose to more than 70% (hazard ratio, 0.29; P < .001) after adjustment for gender and baseline characteristics.

In the arm randomized to the precision strategy, 16% were characterized as low risk and received no further testing. Almost all the others underwent cCTA alone (48%) or cCTA with fractional flow reserve (FFR) (31%). Stress echocardiography, treadmill electrocardiography, and other functional studies were performed in the small proportion of remaining patients.
 

cCTA performed in just 15% of usual care

In the usual-care arm, cCTA with or without FFR was only performed in 15%. More than 80% of patients underwent evaluations with one or more of an array of functional tests. For example, one-third were evaluated with single photon emission CT/PET and nearly as many underwent stress echocardiography testing. Only 7% in usual care underwent no testing after referral.

Within the MACE composite endpoint, almost all the relative benefit in the precision strategy arm was derived from the endpoint of angiography performed without evidence of obstructive CAD (2.6% vs. 10.2%). Rates of all-cause mortality and MI were not significantly different.

Important for the safety and utility of the precision strategy, there “were no deaths or MI events among those assigned deferred testing ” in that experimental arm, according to Dr. Douglas, professor of research in cardiovascular diseases at Duke University, Durham, N.C.

Instead, those in the precision strategy arm were far less likely to undergo catheterization without finding CAD (20% vs. 60%) and far less likely to undergo catheterization without revascularization (28% vs. 70%).

In addition, the group randomized to the precision strategy were more likely to be placed on risk reducing therapies following testing. Although the higher proportion of patients placed on antihypertensive therapy did not reach statistical significance (P = .1), the increased proportions placed on lipid therapy (P < .001) and antiplatelet therapy (P < .001) did.

Citing a study in JAMA Cardiology that found that more than 25% of patients presenting with stable chest pain have normal coronary arteries, Dr. Douglas said that the precision strategy as shown in the PRECISE trial addresses several agreed-upon goals in guidelines from the AHA, the European Society of Cardiology and the U.K.’s National Institute for Health and Care Excellence. These goals include reducing unnecessary testing by risk stratification, improving diagnostic yield of the testing that is performed, and avoiding the costs and complications of unneeded invasive testing.

New protocol called preferred approach

On the basis of these results, Dr. Douglas called the precision strategy “a preferred approach in evaluating patients with stable symptoms and suspected coronary disease.”

Julie Indik, MD, PhD, a professor of medicine at the University of Arizona, Tuscon, said that application of this approach in routine care could have “a major impact on care” by avoiding unnecessary tests with no apparent adverse effect on outcomes.

Although not demonstrated in this study, Dr. Indik suggested that the large number of patients tested for CAD each year – she estimated 4 million visits – means that less testing is likely to have a major impact on the costs of care, and she praised “the practical, efficient” approach of the precision strategy.

Ted Bosworth/MDedge News

Ron Blankstein, MD, director of cardiac computed tomography, Brigham and Women’s Hospital, Boston, also said these data “have both economic and safety implications.” As an AHA-invited discussant of this study, he emphasized that this is a strategy that should only be applied to lower risk patients with no prior history of CAD, but, in this group, he believes these data “will inform future guidelines.”

Dr. Douglas declined to speculate on whether the precision strategy will be incorporated into future guidelines, but she did say that the PRECISE data demonstrate that this approach improves quality of care.

In an interview, Dr. Douglas suggested that this care pathway could provide a basis on which to demonstrate improved outcomes with more efficient use of resources, a common definition of quality care delivery.

Dr. Douglas reported financial relationships with Caption Health, Kowa, and Heartflow, which provided funding for the PRECISE trial. Dr. Indik reported no potential conflicts of interest. Dr. Blankstein reported financial relationships with Amgen, Caristo Diagnostics, and Novartis.

CHICAGO – A stepwise care pathway was associated with a substantial reduction in the number of invasive tests performed and a major improvement in outcomes, relative to usual management, in patients suspected of coronary artery disease (CAD), according to 1-year results of the multinational, randomized PRECISE trial.

The care pathway is appropriate for patients with nonacute chest pain or equivalent complaints that have raised suspicion of CAD, and it is extremely simple, according to the description from the principal investigator, Pamela S. Douglas, MD, given in her presentation at the annual scientific sessions of the American Heart Association.

Ted Bosworth/MDedge News

Unlike the highly complex diagnostic algorithms shunting suspected CAD patients to the vast array of potential evaluations, the newly tested protocol, characterized as a “precision strategy,” divides patients into those who are immediate candidates for invasive testing and those who are not. The discriminator is the PROMISE minimal risk assessment score, a tool already validated.

Those deemed candidates for testing on the basis of an elevated score undergo computed coronary CT angiography (cCTA). In those who are not, testing is deferred.
 

Strategy is simple but effective

Although simple, this pathway is highly effective, judging by the results of the PRECISE trial, which tested the strategy in 2,103 patients at 65 sites in North America and Europe. The primary outcome was a composite of major adverse cardiovascular events (MACE) that included death, nonfatal MI, and catheterization without observed CAD.

After a median follow-up of 11.8 months, the primary MACE endpoint was reached in about 11.3% of those in the usual-care group, which was more than twofold higher than the 4.2% in the precision strategy group. The unadjusted risk reduction was 65% but rose to more than 70% (hazard ratio, 0.29; P < .001) after adjustment for gender and baseline characteristics.

In the arm randomized to the precision strategy, 16% were characterized as low risk and received no further testing. Almost all the others underwent cCTA alone (48%) or cCTA with fractional flow reserve (FFR) (31%). Stress echocardiography, treadmill electrocardiography, and other functional studies were performed in the small proportion of remaining patients.
 

cCTA performed in just 15% of usual care

In the usual-care arm, cCTA with or without FFR was only performed in 15%. More than 80% of patients underwent evaluations with one or more of an array of functional tests. For example, one-third were evaluated with single photon emission CT/PET and nearly as many underwent stress echocardiography testing. Only 7% in usual care underwent no testing after referral.

Within the MACE composite endpoint, almost all the relative benefit in the precision strategy arm was derived from the endpoint of angiography performed without evidence of obstructive CAD (2.6% vs. 10.2%). Rates of all-cause mortality and MI were not significantly different.

Important for the safety and utility of the precision strategy, there “were no deaths or MI events among those assigned deferred testing ” in that experimental arm, according to Dr. Douglas, professor of research in cardiovascular diseases at Duke University, Durham, N.C.

Instead, those in the precision strategy arm were far less likely to undergo catheterization without finding CAD (20% vs. 60%) and far less likely to undergo catheterization without revascularization (28% vs. 70%).

In addition, the group randomized to the precision strategy were more likely to be placed on risk reducing therapies following testing. Although the higher proportion of patients placed on antihypertensive therapy did not reach statistical significance (P = .1), the increased proportions placed on lipid therapy (P < .001) and antiplatelet therapy (P < .001) did.

Citing a study in JAMA Cardiology that found that more than 25% of patients presenting with stable chest pain have normal coronary arteries, Dr. Douglas said that the precision strategy as shown in the PRECISE trial addresses several agreed-upon goals in guidelines from the AHA, the European Society of Cardiology and the U.K.’s National Institute for Health and Care Excellence. These goals include reducing unnecessary testing by risk stratification, improving diagnostic yield of the testing that is performed, and avoiding the costs and complications of unneeded invasive testing.

New protocol called preferred approach

On the basis of these results, Dr. Douglas called the precision strategy “a preferred approach in evaluating patients with stable symptoms and suspected coronary disease.”

Julie Indik, MD, PhD, a professor of medicine at the University of Arizona, Tuscon, said that application of this approach in routine care could have “a major impact on care” by avoiding unnecessary tests with no apparent adverse effect on outcomes.

Although not demonstrated in this study, Dr. Indik suggested that the large number of patients tested for CAD each year – she estimated 4 million visits – means that less testing is likely to have a major impact on the costs of care, and she praised “the practical, efficient” approach of the precision strategy.

Ted Bosworth/MDedge News

Ron Blankstein, MD, director of cardiac computed tomography, Brigham and Women’s Hospital, Boston, also said these data “have both economic and safety implications.” As an AHA-invited discussant of this study, he emphasized that this is a strategy that should only be applied to lower risk patients with no prior history of CAD, but, in this group, he believes these data “will inform future guidelines.”

Dr. Douglas declined to speculate on whether the precision strategy will be incorporated into future guidelines, but she did say that the PRECISE data demonstrate that this approach improves quality of care.

In an interview, Dr. Douglas suggested that this care pathway could provide a basis on which to demonstrate improved outcomes with more efficient use of resources, a common definition of quality care delivery.

Dr. Douglas reported financial relationships with Caption Health, Kowa, and Heartflow, which provided funding for the PRECISE trial. Dr. Indik reported no potential conflicts of interest. Dr. Blankstein reported financial relationships with Amgen, Caristo Diagnostics, and Novartis.

CHICAGO – A stepwise care pathway was associated with a substantial reduction in the number of invasive tests performed and a major improvement in outcomes, relative to usual management, in patients suspected of coronary artery disease (CAD), according to 1-year results of the multinational, randomized PRECISE trial.

The care pathway is appropriate for patients with nonacute chest pain or equivalent complaints that have raised suspicion of CAD, and it is extremely simple, according to the description from the principal investigator, Pamela S. Douglas, MD, given in her presentation at the annual scientific sessions of the American Heart Association.

Ted Bosworth/MDedge News

Unlike the highly complex diagnostic algorithms shunting suspected CAD patients to the vast array of potential evaluations, the newly tested protocol, characterized as a “precision strategy,” divides patients into those who are immediate candidates for invasive testing and those who are not. The discriminator is the PROMISE minimal risk assessment score, a tool already validated.

Those deemed candidates for testing on the basis of an elevated score undergo computed coronary CT angiography (cCTA). In those who are not, testing is deferred.
 

Strategy is simple but effective

Although simple, this pathway is highly effective, judging by the results of the PRECISE trial, which tested the strategy in 2,103 patients at 65 sites in North America and Europe. The primary outcome was a composite of major adverse cardiovascular events (MACE) that included death, nonfatal MI, and catheterization without observed CAD.

After a median follow-up of 11.8 months, the primary MACE endpoint was reached in about 11.3% of those in the usual-care group, which was more than twofold higher than the 4.2% in the precision strategy group. The unadjusted risk reduction was 65% but rose to more than 70% (hazard ratio, 0.29; P < .001) after adjustment for gender and baseline characteristics.

In the arm randomized to the precision strategy, 16% were characterized as low risk and received no further testing. Almost all the others underwent cCTA alone (48%) or cCTA with fractional flow reserve (FFR) (31%). Stress echocardiography, treadmill electrocardiography, and other functional studies were performed in the small proportion of remaining patients.
 

cCTA performed in just 15% of usual care

In the usual-care arm, cCTA with or without FFR was only performed in 15%. More than 80% of patients underwent evaluations with one or more of an array of functional tests. For example, one-third were evaluated with single photon emission CT/PET and nearly as many underwent stress echocardiography testing. Only 7% in usual care underwent no testing after referral.

Within the MACE composite endpoint, almost all the relative benefit in the precision strategy arm was derived from the endpoint of angiography performed without evidence of obstructive CAD (2.6% vs. 10.2%). Rates of all-cause mortality and MI were not significantly different.

Important for the safety and utility of the precision strategy, there “were no deaths or MI events among those assigned deferred testing ” in that experimental arm, according to Dr. Douglas, professor of research in cardiovascular diseases at Duke University, Durham, N.C.

Instead, those in the precision strategy arm were far less likely to undergo catheterization without finding CAD (20% vs. 60%) and far less likely to undergo catheterization without revascularization (28% vs. 70%).

In addition, the group randomized to the precision strategy were more likely to be placed on risk reducing therapies following testing. Although the higher proportion of patients placed on antihypertensive therapy did not reach statistical significance (P = .1), the increased proportions placed on lipid therapy (P < .001) and antiplatelet therapy (P < .001) did.

Citing a study in JAMA Cardiology that found that more than 25% of patients presenting with stable chest pain have normal coronary arteries, Dr. Douglas said that the precision strategy as shown in the PRECISE trial addresses several agreed-upon goals in guidelines from the AHA, the European Society of Cardiology and the U.K.’s National Institute for Health and Care Excellence. These goals include reducing unnecessary testing by risk stratification, improving diagnostic yield of the testing that is performed, and avoiding the costs and complications of unneeded invasive testing.

New protocol called preferred approach

On the basis of these results, Dr. Douglas called the precision strategy “a preferred approach in evaluating patients with stable symptoms and suspected coronary disease.”

Julie Indik, MD, PhD, a professor of medicine at the University of Arizona, Tuscon, said that application of this approach in routine care could have “a major impact on care” by avoiding unnecessary tests with no apparent adverse effect on outcomes.

Although not demonstrated in this study, Dr. Indik suggested that the large number of patients tested for CAD each year – she estimated 4 million visits – means that less testing is likely to have a major impact on the costs of care, and she praised “the practical, efficient” approach of the precision strategy.

Ted Bosworth/MDedge News

Ron Blankstein, MD, director of cardiac computed tomography, Brigham and Women’s Hospital, Boston, also said these data “have both economic and safety implications.” As an AHA-invited discussant of this study, he emphasized that this is a strategy that should only be applied to lower risk patients with no prior history of CAD, but, in this group, he believes these data “will inform future guidelines.”

Dr. Douglas declined to speculate on whether the precision strategy will be incorporated into future guidelines, but she did say that the PRECISE data demonstrate that this approach improves quality of care.

In an interview, Dr. Douglas suggested that this care pathway could provide a basis on which to demonstrate improved outcomes with more efficient use of resources, a common definition of quality care delivery.

Dr. Douglas reported financial relationships with Caption Health, Kowa, and Heartflow, which provided funding for the PRECISE trial. Dr. Indik reported no potential conflicts of interest. Dr. Blankstein reported financial relationships with Amgen, Caristo Diagnostics, and Novartis.

Katrina Ubell, MD, listened with growing skepticism as the dietician outlined her weight-loss plan. “You’re going to have to eat a snack in the afternoon,” she instructed.

Dr. Ubell refrained from rolling her eyes. The afternoon was in the middle of clinic. “I’m not ever going to do that,” she tried to explain. “I can’t.”

“Of course, you can,” the dietician insisted. “You shouldn’t think that way. You get to decide.”

“She wasn’t wrong about that,” Dr. Ubell conceded years later. But the well-meaning dietician couldn’t understand the reality of life as a physician. As a pediatrician, Dr. Ubell could visualize how her afternoon would play out. “You’re already 40 minutes behind. This mom needs to get home to get her kid off the bus. This mom, her toddler is losing his mind because he needs a nap. You’re not going to say: ‘Sorry, I need to eat some carrots and hummus.’ ”

Most of what the dieting realm recommends for weight loss, Dr. Ubell discovered, seems only relevant to people with a consistent 9 to 5 schedule. That was not her life. Neither was she looking for one of the many diet plans based on self-denial and will power. Having already lost and gained back 40 pounds several times, she knew these methods were not effective long term.

What were other overweight doctors doing? she wondered. Someone must know how to help doctors lose weight. But her Google searches revealed ... nothing. No one was offering a useful diet or exercise plan specifically for physicians.

Dr. Ubell’s search for answers led to the world of life coaching, and eventually she became a master-certified life and weight-loss coach, working exclusively with women-identifying physicians.

The field is small. Very few weight-loss programs are solely for physicians, whose stress levels, unpredictable schedules, and high-achieving mindset pose unique challenges. Among the constantly changing diet fads, few would likely work for the surgeon confined to an operating room for 9 hours at a time or the anesthesiologist who can’t even manage to drink water during the workday.

Dr. Ubell set out to create a weight-loss program rooted in the physical and mental demands of medical practice. In the process, she lost 45 pounds.
 

Step 1: Acknowledge that doctors are, unfortunately, human

Dr. Ubell’s approach to food combines concepts from cognitive-behavioral therapy with personalized eating plans, coaching, and support from a community of doctors.

All of this stems from her own experience with emotional eating, which she said many doctors use to process their stress and exhaustion. This is a direct result of needing to repress emotions while caring for patients but lacking guidance on how to manage those feelings outside of work.

“That kind of behavior, being what we call ‘professional,’ but really emotionally shut down, is prized and valued in medicine,” Dr. Ubell said. “I’m not saying we should be open all the time. But we’re not given any tools for what to do at the end of the day. In my case, it was eating. For other people, it’s drinking more than they would like, spending money, gambling, basically just numbing behavior.”

Dr. Ubell said only 20% of her work with clients revolves around what to eat. The other 80% is about managing the thoughts, beliefs, and emotions that negatively affect their lives, teaching them how to cope “without food as the crutch.” Once the problems regarding eating are resolved, clients can begin to address all the problems they were using food to obscure.

“A lot of my clients really have to work on self-love, self-acceptance, self-compassion,” Dr. Ubell said. “They’re such high achievers, and often many of them think that they’ve achieved so much by being harsh with themselves and driving themselves hard. They think it’s causal, but it’s not. They have to learn, How can I be accomplished while being nice to myself?”
 

Step 2: Reassess your mindset

Ali Novitsky, MD, an obesity medicine physician and now full-time life coach, calls this attitude the “heaven’s reward fallacy.” Observed by renowned psychiatrist Aaron Beck, MD, this cognitive distortion involves imagining that hard work, struggle, and self-sacrifice must ultimately pay off, as if suffering entitles us to compensation in the future. For physicians, who are embedded in a culture of selflessness and dedication to the health of others, this often means forfeiting their own health and well-being.

For many, there is also a sense of secrecy and shame regarding health and fitness problems. As doctors, they are experts in the human body. They should already know how to lose weight. Right? And so not knowing or being unable to muster the will power for a diet plan while on call overnight or working 12-hour shifts feels like a professional failure as well as a personal one.

“As physicians, we’re so afraid to fail,” Dr. Novitsky explained. “It’s more comfortable just to not know. Maybe we’ve failed before, or maybe we didn’t get the result that we wanted, so now we can’t bear to have that happen again. It’s just way too painful.”

Dr. Novitsky – who has herself lost 50 pounds and have kept it off for 20 years – provides weight loss, intuitive eating, and fitness programs for female physicians. Her evidence-based approach aims to optimize body composition rather than hitting a number on a scale. Conscious of the physician lifestyle, she offers night and weekend meetings, sessions that can be replayed, and even an “on-call workout” series designed for being in the call room.

Dr. Novitsky notices that many of her clients are stuck in an “all-or-none” mindset. If they can’t do something perfectly with total commitment, they would rather not do it at all. With so many demands on their time and energy, something has to give, and putting their health first begins to seem selfish or hopeless. “I can speak to this,” Dr. Novitsky admitted, “because I did it to myself”

Like Dr. Ubell, Dr. Novitsky said that “most of the stuff we’re coaching on is not about their food. It’s about how they feel undervalued at work, how their relationships are suffering, how they feel super guilty as a parent. They feel like they look good on paper, but this is not the life they signed up for.”
 

Step 3: Life change equals physical change

Siobhan Key, MD, an obesity medicine and family physician, sees her own weight loss struggle as a symptom of a former lifestyle that, frankly, “sucked.”

Her grueling schedule and lack of self-care left her feeling stuck on a “hamster wheel” of work and family responsibilities. There was no space for herself. She craved the dopamine burst from junk food and felt powerless to stop reaching for Wendy’s French fries as a frequent reward. It took realizing that she was on track to develop type 2 diabetes to motivate her to change.

Where she lived also affected her struggle. Living in the small community of Prince George, B.C., local weight-loss programs were difficult for Dr. Key. It was likely that she would encounter some of her patients, which would not be a safe space to reveal her personal challenges. Searching for an expert who could explain how to eat healthy meals while on call and then working a full day afterward also yielded no solutions.

Unlike Dr. Ubell and Dr. Novitsky, Dr. Key still practices medicine. But she is also a weight-loss coach. She takes an unconventional approach by not proposing any specific diet rules or plans. Dictating which foods you can or cannot eat is like trying to fit a square peg into a round hole, Dr. Key said. It will never work long term. Instead, she wants to help her clients use both their medical knowledge and life experience to make healthy eating fit into their lives.

“Let’s stop doing things that makes our lives worse just to lose weight, because it will never be sustainable,” said Dr. Key. “Rather, let’s choose paths of losing weight and managing our eating that actually make our lives better. And those exist. They’re just not the classic diet paths that we’ve been taught before.”

Dr. Key’s program also includes advice from other physician coaches on professional struggles. For example, charting is a big one, Dr. Key said. The pressure of completing patient notes, often outside of working hours, is a major source of stress that triggers a lot of eating.

Weight loss doesn’t happen in a vacuum, Dr. Key pointed out. It isn’t the simple “eat less, exercise more” equation that physicians learned in medical school. “The reality is, weight loss and eating happen in conjunction with the rest of your life,” she said.

Find ways to make your life easier and the benefits will follow, she said. “As your life gets better, you feel more empowered. You feel less stressed. Your eating choices start to be simpler, and the cravings start to go down. You can’t have one without the other.”
 

Weight is just a symptom of a bigger problem

Dr. Ubell, Dr. Novitsky, and Dr. Key all say they have seen dramatic transformations among their clients. They don’t mean just physical ones. Dr. Ubell remembered an emergency medicine physician so miserable at work that she considered defaulting on her student loans. Dr. Novitsky recalled an anesthesiologist so insecure that she nearly passed up a scholarship to a fitness program. Dr. Key has seen clients so obsessed with what they should and shouldn’t eat that food dominated their thoughts every free minute of the day.

All these doctors, the coaches said, have been able to regain a sense of control over their lives, rethink how they show up at work and at home, and even rediscover their joy in medicine.

These changes are less about body mass index and more about confidence and self-love. For weight loss to last, according to Dr. Ubell, Dr. Novitsky, and Dr. Key, there must be permanent mental shifts that redefine one’s relationship with food.

“There’s no finish line when we’re talking about long-term weight maintenance,” Dr. Key tells physicians. “You have to be able to do it for the rest of your life.”

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

Katrina Ubell, MD, listened with growing skepticism as the dietician outlined her weight-loss plan. “You’re going to have to eat a snack in the afternoon,” she instructed.

Dr. Ubell refrained from rolling her eyes. The afternoon was in the middle of clinic. “I’m not ever going to do that,” she tried to explain. “I can’t.”

“Of course, you can,” the dietician insisted. “You shouldn’t think that way. You get to decide.”

“She wasn’t wrong about that,” Dr. Ubell conceded years later. But the well-meaning dietician couldn’t understand the reality of life as a physician. As a pediatrician, Dr. Ubell could visualize how her afternoon would play out. “You’re already 40 minutes behind. This mom needs to get home to get her kid off the bus. This mom, her toddler is losing his mind because he needs a nap. You’re not going to say: ‘Sorry, I need to eat some carrots and hummus.’ ”

Most of what the dieting realm recommends for weight loss, Dr. Ubell discovered, seems only relevant to people with a consistent 9 to 5 schedule. That was not her life. Neither was she looking for one of the many diet plans based on self-denial and will power. Having already lost and gained back 40 pounds several times, she knew these methods were not effective long term.

What were other overweight doctors doing? she wondered. Someone must know how to help doctors lose weight. But her Google searches revealed ... nothing. No one was offering a useful diet or exercise plan specifically for physicians.

Dr. Ubell’s search for answers led to the world of life coaching, and eventually she became a master-certified life and weight-loss coach, working exclusively with women-identifying physicians.

The field is small. Very few weight-loss programs are solely for physicians, whose stress levels, unpredictable schedules, and high-achieving mindset pose unique challenges. Among the constantly changing diet fads, few would likely work for the surgeon confined to an operating room for 9 hours at a time or the anesthesiologist who can’t even manage to drink water during the workday.

Dr. Ubell set out to create a weight-loss program rooted in the physical and mental demands of medical practice. In the process, she lost 45 pounds.
 

Step 1: Acknowledge that doctors are, unfortunately, human

Dr. Ubell’s approach to food combines concepts from cognitive-behavioral therapy with personalized eating plans, coaching, and support from a community of doctors.

All of this stems from her own experience with emotional eating, which she said many doctors use to process their stress and exhaustion. This is a direct result of needing to repress emotions while caring for patients but lacking guidance on how to manage those feelings outside of work.

“That kind of behavior, being what we call ‘professional,’ but really emotionally shut down, is prized and valued in medicine,” Dr. Ubell said. “I’m not saying we should be open all the time. But we’re not given any tools for what to do at the end of the day. In my case, it was eating. For other people, it’s drinking more than they would like, spending money, gambling, basically just numbing behavior.”

Dr. Ubell said only 20% of her work with clients revolves around what to eat. The other 80% is about managing the thoughts, beliefs, and emotions that negatively affect their lives, teaching them how to cope “without food as the crutch.” Once the problems regarding eating are resolved, clients can begin to address all the problems they were using food to obscure.

“A lot of my clients really have to work on self-love, self-acceptance, self-compassion,” Dr. Ubell said. “They’re such high achievers, and often many of them think that they’ve achieved so much by being harsh with themselves and driving themselves hard. They think it’s causal, but it’s not. They have to learn, How can I be accomplished while being nice to myself?”
 

Step 2: Reassess your mindset

Ali Novitsky, MD, an obesity medicine physician and now full-time life coach, calls this attitude the “heaven’s reward fallacy.” Observed by renowned psychiatrist Aaron Beck, MD, this cognitive distortion involves imagining that hard work, struggle, and self-sacrifice must ultimately pay off, as if suffering entitles us to compensation in the future. For physicians, who are embedded in a culture of selflessness and dedication to the health of others, this often means forfeiting their own health and well-being.

For many, there is also a sense of secrecy and shame regarding health and fitness problems. As doctors, they are experts in the human body. They should already know how to lose weight. Right? And so not knowing or being unable to muster the will power for a diet plan while on call overnight or working 12-hour shifts feels like a professional failure as well as a personal one.

“As physicians, we’re so afraid to fail,” Dr. Novitsky explained. “It’s more comfortable just to not know. Maybe we’ve failed before, or maybe we didn’t get the result that we wanted, so now we can’t bear to have that happen again. It’s just way too painful.”

Dr. Novitsky – who has herself lost 50 pounds and have kept it off for 20 years – provides weight loss, intuitive eating, and fitness programs for female physicians. Her evidence-based approach aims to optimize body composition rather than hitting a number on a scale. Conscious of the physician lifestyle, she offers night and weekend meetings, sessions that can be replayed, and even an “on-call workout” series designed for being in the call room.

Dr. Novitsky notices that many of her clients are stuck in an “all-or-none” mindset. If they can’t do something perfectly with total commitment, they would rather not do it at all. With so many demands on their time and energy, something has to give, and putting their health first begins to seem selfish or hopeless. “I can speak to this,” Dr. Novitsky admitted, “because I did it to myself”

Like Dr. Ubell, Dr. Novitsky said that “most of the stuff we’re coaching on is not about their food. It’s about how they feel undervalued at work, how their relationships are suffering, how they feel super guilty as a parent. They feel like they look good on paper, but this is not the life they signed up for.”
 

Step 3: Life change equals physical change

Siobhan Key, MD, an obesity medicine and family physician, sees her own weight loss struggle as a symptom of a former lifestyle that, frankly, “sucked.”

Her grueling schedule and lack of self-care left her feeling stuck on a “hamster wheel” of work and family responsibilities. There was no space for herself. She craved the dopamine burst from junk food and felt powerless to stop reaching for Wendy’s French fries as a frequent reward. It took realizing that she was on track to develop type 2 diabetes to motivate her to change.

Where she lived also affected her struggle. Living in the small community of Prince George, B.C., local weight-loss programs were difficult for Dr. Key. It was likely that she would encounter some of her patients, which would not be a safe space to reveal her personal challenges. Searching for an expert who could explain how to eat healthy meals while on call and then working a full day afterward also yielded no solutions.

Unlike Dr. Ubell and Dr. Novitsky, Dr. Key still practices medicine. But she is also a weight-loss coach. She takes an unconventional approach by not proposing any specific diet rules or plans. Dictating which foods you can or cannot eat is like trying to fit a square peg into a round hole, Dr. Key said. It will never work long term. Instead, she wants to help her clients use both their medical knowledge and life experience to make healthy eating fit into their lives.

“Let’s stop doing things that makes our lives worse just to lose weight, because it will never be sustainable,” said Dr. Key. “Rather, let’s choose paths of losing weight and managing our eating that actually make our lives better. And those exist. They’re just not the classic diet paths that we’ve been taught before.”

Dr. Key’s program also includes advice from other physician coaches on professional struggles. For example, charting is a big one, Dr. Key said. The pressure of completing patient notes, often outside of working hours, is a major source of stress that triggers a lot of eating.

Weight loss doesn’t happen in a vacuum, Dr. Key pointed out. It isn’t the simple “eat less, exercise more” equation that physicians learned in medical school. “The reality is, weight loss and eating happen in conjunction with the rest of your life,” she said.

Find ways to make your life easier and the benefits will follow, she said. “As your life gets better, you feel more empowered. You feel less stressed. Your eating choices start to be simpler, and the cravings start to go down. You can’t have one without the other.”
 

Weight is just a symptom of a bigger problem

Dr. Ubell, Dr. Novitsky, and Dr. Key all say they have seen dramatic transformations among their clients. They don’t mean just physical ones. Dr. Ubell remembered an emergency medicine physician so miserable at work that she considered defaulting on her student loans. Dr. Novitsky recalled an anesthesiologist so insecure that she nearly passed up a scholarship to a fitness program. Dr. Key has seen clients so obsessed with what they should and shouldn’t eat that food dominated their thoughts every free minute of the day.

All these doctors, the coaches said, have been able to regain a sense of control over their lives, rethink how they show up at work and at home, and even rediscover their joy in medicine.

These changes are less about body mass index and more about confidence and self-love. For weight loss to last, according to Dr. Ubell, Dr. Novitsky, and Dr. Key, there must be permanent mental shifts that redefine one’s relationship with food.

“There’s no finish line when we’re talking about long-term weight maintenance,” Dr. Key tells physicians. “You have to be able to do it for the rest of your life.”

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

Katrina Ubell, MD, listened with growing skepticism as the dietician outlined her weight-loss plan. “You’re going to have to eat a snack in the afternoon,” she instructed.

Dr. Ubell refrained from rolling her eyes. The afternoon was in the middle of clinic. “I’m not ever going to do that,” she tried to explain. “I can’t.”

“Of course, you can,” the dietician insisted. “You shouldn’t think that way. You get to decide.”

“She wasn’t wrong about that,” Dr. Ubell conceded years later. But the well-meaning dietician couldn’t understand the reality of life as a physician. As a pediatrician, Dr. Ubell could visualize how her afternoon would play out. “You’re already 40 minutes behind. This mom needs to get home to get her kid off the bus. This mom, her toddler is losing his mind because he needs a nap. You’re not going to say: ‘Sorry, I need to eat some carrots and hummus.’ ”

Most of what the dieting realm recommends for weight loss, Dr. Ubell discovered, seems only relevant to people with a consistent 9 to 5 schedule. That was not her life. Neither was she looking for one of the many diet plans based on self-denial and will power. Having already lost and gained back 40 pounds several times, she knew these methods were not effective long term.

What were other overweight doctors doing? she wondered. Someone must know how to help doctors lose weight. But her Google searches revealed ... nothing. No one was offering a useful diet or exercise plan specifically for physicians.

Dr. Ubell’s search for answers led to the world of life coaching, and eventually she became a master-certified life and weight-loss coach, working exclusively with women-identifying physicians.

The field is small. Very few weight-loss programs are solely for physicians, whose stress levels, unpredictable schedules, and high-achieving mindset pose unique challenges. Among the constantly changing diet fads, few would likely work for the surgeon confined to an operating room for 9 hours at a time or the anesthesiologist who can’t even manage to drink water during the workday.

Dr. Ubell set out to create a weight-loss program rooted in the physical and mental demands of medical practice. In the process, she lost 45 pounds.
 

Step 1: Acknowledge that doctors are, unfortunately, human

Dr. Ubell’s approach to food combines concepts from cognitive-behavioral therapy with personalized eating plans, coaching, and support from a community of doctors.

All of this stems from her own experience with emotional eating, which she said many doctors use to process their stress and exhaustion. This is a direct result of needing to repress emotions while caring for patients but lacking guidance on how to manage those feelings outside of work.

“That kind of behavior, being what we call ‘professional,’ but really emotionally shut down, is prized and valued in medicine,” Dr. Ubell said. “I’m not saying we should be open all the time. But we’re not given any tools for what to do at the end of the day. In my case, it was eating. For other people, it’s drinking more than they would like, spending money, gambling, basically just numbing behavior.”

Dr. Ubell said only 20% of her work with clients revolves around what to eat. The other 80% is about managing the thoughts, beliefs, and emotions that negatively affect their lives, teaching them how to cope “without food as the crutch.” Once the problems regarding eating are resolved, clients can begin to address all the problems they were using food to obscure.

“A lot of my clients really have to work on self-love, self-acceptance, self-compassion,” Dr. Ubell said. “They’re such high achievers, and often many of them think that they’ve achieved so much by being harsh with themselves and driving themselves hard. They think it’s causal, but it’s not. They have to learn, How can I be accomplished while being nice to myself?”
 

Step 2: Reassess your mindset

Ali Novitsky, MD, an obesity medicine physician and now full-time life coach, calls this attitude the “heaven’s reward fallacy.” Observed by renowned psychiatrist Aaron Beck, MD, this cognitive distortion involves imagining that hard work, struggle, and self-sacrifice must ultimately pay off, as if suffering entitles us to compensation in the future. For physicians, who are embedded in a culture of selflessness and dedication to the health of others, this often means forfeiting their own health and well-being.

For many, there is also a sense of secrecy and shame regarding health and fitness problems. As doctors, they are experts in the human body. They should already know how to lose weight. Right? And so not knowing or being unable to muster the will power for a diet plan while on call overnight or working 12-hour shifts feels like a professional failure as well as a personal one.

“As physicians, we’re so afraid to fail,” Dr. Novitsky explained. “It’s more comfortable just to not know. Maybe we’ve failed before, or maybe we didn’t get the result that we wanted, so now we can’t bear to have that happen again. It’s just way too painful.”

Dr. Novitsky – who has herself lost 50 pounds and have kept it off for 20 years – provides weight loss, intuitive eating, and fitness programs for female physicians. Her evidence-based approach aims to optimize body composition rather than hitting a number on a scale. Conscious of the physician lifestyle, she offers night and weekend meetings, sessions that can be replayed, and even an “on-call workout” series designed for being in the call room.

Dr. Novitsky notices that many of her clients are stuck in an “all-or-none” mindset. If they can’t do something perfectly with total commitment, they would rather not do it at all. With so many demands on their time and energy, something has to give, and putting their health first begins to seem selfish or hopeless. “I can speak to this,” Dr. Novitsky admitted, “because I did it to myself”

Like Dr. Ubell, Dr. Novitsky said that “most of the stuff we’re coaching on is not about their food. It’s about how they feel undervalued at work, how their relationships are suffering, how they feel super guilty as a parent. They feel like they look good on paper, but this is not the life they signed up for.”
 

Step 3: Life change equals physical change

Siobhan Key, MD, an obesity medicine and family physician, sees her own weight loss struggle as a symptom of a former lifestyle that, frankly, “sucked.”

Her grueling schedule and lack of self-care left her feeling stuck on a “hamster wheel” of work and family responsibilities. There was no space for herself. She craved the dopamine burst from junk food and felt powerless to stop reaching for Wendy’s French fries as a frequent reward. It took realizing that she was on track to develop type 2 diabetes to motivate her to change.

Where she lived also affected her struggle. Living in the small community of Prince George, B.C., local weight-loss programs were difficult for Dr. Key. It was likely that she would encounter some of her patients, which would not be a safe space to reveal her personal challenges. Searching for an expert who could explain how to eat healthy meals while on call and then working a full day afterward also yielded no solutions.

Unlike Dr. Ubell and Dr. Novitsky, Dr. Key still practices medicine. But she is also a weight-loss coach. She takes an unconventional approach by not proposing any specific diet rules or plans. Dictating which foods you can or cannot eat is like trying to fit a square peg into a round hole, Dr. Key said. It will never work long term. Instead, she wants to help her clients use both their medical knowledge and life experience to make healthy eating fit into their lives.

“Let’s stop doing things that makes our lives worse just to lose weight, because it will never be sustainable,” said Dr. Key. “Rather, let’s choose paths of losing weight and managing our eating that actually make our lives better. And those exist. They’re just not the classic diet paths that we’ve been taught before.”

Dr. Key’s program also includes advice from other physician coaches on professional struggles. For example, charting is a big one, Dr. Key said. The pressure of completing patient notes, often outside of working hours, is a major source of stress that triggers a lot of eating.

Weight loss doesn’t happen in a vacuum, Dr. Key pointed out. It isn’t the simple “eat less, exercise more” equation that physicians learned in medical school. “The reality is, weight loss and eating happen in conjunction with the rest of your life,” she said.

Find ways to make your life easier and the benefits will follow, she said. “As your life gets better, you feel more empowered. You feel less stressed. Your eating choices start to be simpler, and the cravings start to go down. You can’t have one without the other.”
 

Weight is just a symptom of a bigger problem

Dr. Ubell, Dr. Novitsky, and Dr. Key all say they have seen dramatic transformations among their clients. They don’t mean just physical ones. Dr. Ubell remembered an emergency medicine physician so miserable at work that she considered defaulting on her student loans. Dr. Novitsky recalled an anesthesiologist so insecure that she nearly passed up a scholarship to a fitness program. Dr. Key has seen clients so obsessed with what they should and shouldn’t eat that food dominated their thoughts every free minute of the day.

All these doctors, the coaches said, have been able to regain a sense of control over their lives, rethink how they show up at work and at home, and even rediscover their joy in medicine.

These changes are less about body mass index and more about confidence and self-love. For weight loss to last, according to Dr. Ubell, Dr. Novitsky, and Dr. Key, there must be permanent mental shifts that redefine one’s relationship with food.

“There’s no finish line when we’re talking about long-term weight maintenance,” Dr. Key tells physicians. “You have to be able to do it for the rest of your life.”

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

Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

A man in England who was infected with an early strain of COVID-19 was finally cleared 411 days after first testing positive, according to experts in the United Kingdom. 

The man was treated with a mixture of neutralizing monoclonal antibodies, King’s College London said in a news release.

The man, 59, tested positive in December 2020 and tested negative in January 2022. He had a weakened immune system because of a previous kidney transplant. He received three doses of vaccine and his symptoms lessened, but he kept testing positive for COVID.

To find out if the man had a persistent infection or had been infected several times, doctors did a genetic analysis of the virus.

“This revealed that the patient’s infection was a persistent infection with an early COVID variant – a variation of the original Wuhan variant that was dominant in the United Kingdom in the later months of 2020. Analysis found the patient’s virus had multiple mutations since he was first infected,” King’s College said.

The doctors treated him with a Regeneron treatment that is no longer widely used because it’s not effective against newer COVID variants.

“Some new variants of the virus are resistant to all the antibody treatments available in the United Kingdom and Europe. Some people with weakened immune systems are still at risk of severe illness and becoming persistently infected. We are still working to understand the best way to protect and treat them,” Luke Snell, MD, from the King’s College School of Immunology & Microbial Sciences, said in the news release.

This is one of the longest known cases of COVID infection. Another man in England was infected with COVID for 505 days before his death, which King’s College said was the longest known COVID infection.

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

A man in England who was infected with an early strain of COVID-19 was finally cleared 411 days after first testing positive, according to experts in the United Kingdom. 

The man was treated with a mixture of neutralizing monoclonal antibodies, King’s College London said in a news release.

The man, 59, tested positive in December 2020 and tested negative in January 2022. He had a weakened immune system because of a previous kidney transplant. He received three doses of vaccine and his symptoms lessened, but he kept testing positive for COVID.

To find out if the man had a persistent infection or had been infected several times, doctors did a genetic analysis of the virus.

“This revealed that the patient’s infection was a persistent infection with an early COVID variant – a variation of the original Wuhan variant that was dominant in the United Kingdom in the later months of 2020. Analysis found the patient’s virus had multiple mutations since he was first infected,” King’s College said.

The doctors treated him with a Regeneron treatment that is no longer widely used because it’s not effective against newer COVID variants.

“Some new variants of the virus are resistant to all the antibody treatments available in the United Kingdom and Europe. Some people with weakened immune systems are still at risk of severe illness and becoming persistently infected. We are still working to understand the best way to protect and treat them,” Luke Snell, MD, from the King’s College School of Immunology & Microbial Sciences, said in the news release.

This is one of the longest known cases of COVID infection. Another man in England was infected with COVID for 505 days before his death, which King’s College said was the longest known COVID infection.

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

A man in England who was infected with an early strain of COVID-19 was finally cleared 411 days after first testing positive, according to experts in the United Kingdom. 

The man was treated with a mixture of neutralizing monoclonal antibodies, King’s College London said in a news release.

The man, 59, tested positive in December 2020 and tested negative in January 2022. He had a weakened immune system because of a previous kidney transplant. He received three doses of vaccine and his symptoms lessened, but he kept testing positive for COVID.

To find out if the man had a persistent infection or had been infected several times, doctors did a genetic analysis of the virus.

“This revealed that the patient’s infection was a persistent infection with an early COVID variant – a variation of the original Wuhan variant that was dominant in the United Kingdom in the later months of 2020. Analysis found the patient’s virus had multiple mutations since he was first infected,” King’s College said.

The doctors treated him with a Regeneron treatment that is no longer widely used because it’s not effective against newer COVID variants.

“Some new variants of the virus are resistant to all the antibody treatments available in the United Kingdom and Europe. Some people with weakened immune systems are still at risk of severe illness and becoming persistently infected. We are still working to understand the best way to protect and treat them,” Luke Snell, MD, from the King’s College School of Immunology & Microbial Sciences, said in the news release.

This is one of the longest known cases of COVID infection. Another man in England was infected with COVID for 505 days before his death, which King’s College said was the longest known COVID infection.

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