Cardiology News

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Artificial intelligence (AI)–guided screening using digital stethoscopes doubled the detection of left ventricular systolic dysfunction (LVSD) in pregnant and postpartum women in Nigeria. Cardiomyopathy during pregnancy and post partum is challenging to diagnose because of symptom overlap with normal pregnancy changes. AI-guided screening showed a significant improvement in diagnosis rates, compared with usual care.

METHODOLOGY:

• Researchers conducted an open-label, randomized clinical trial involving 1232 pregnant and postpartum women in Nigeria.
• Participants were randomized to either AI-guided screening using digital stethoscopes and 12-lead ECGs or usual care.
• The primary outcome was the identification of LVSD confirmed by echocardiography.
• Secondary outcomes were AI model performance across subgroups and the effectiveness of AI in identifying various levels of LVSD.

TAKEAWAY:

• AI-guided screening using digital stethoscopes detected LVSD in 4.1% of participants, compared with 2.0% of controls (P = .032).
• The 12-lead AI-ECG model detected LVSD in 3.4% of participants in the intervention arm, compared with 2.0% of those in the control arm (P = .125).
• No serious adverse events related to study participation were reported.
• The study highlighted the potential of AI-guided screening to improve the diagnosis of pregnancy-related cardiomyopathy.

IN PRACTICE:

“Delays in the diagnosis of cardiomyopathy during the peripartum period is associated with poorer outcomes as such, it is imperative that we are able to identify cardiac dysfunction early so that appropriate care can be initiated to reduce associated adverse maternal and infant outcomes,” wrote the authors of the study.
 

SOURCE:

This study was led by Demilade A. Adedinsewo, MBchB, Mayo Clinic in Jacksonville, Florida. It was published online in Nature Medicine.

LIMITATIONS:

The study’s pragmatic design and enrollment at teaching hospitals with echocardiography capabilities limited generalizability. Two thirds of participants were in the third trimester or postpartum at study entry, which limited follow-up visits. The study did not require completion of all seven visits, which led to potential attrition bias. The selected cutoff for LVSD (left ventricular ejection fraction < 50%) did not match the original model specifications, which potentially affected results.

DISCLOSURES:

Dr. Adedinsewo disclosed receiving grants from the Mayo Clinic BIRCWH program funded by the National Institutes of Health. Two coauthors reported holding patents for AI algorithms licensed to Anumana, AliveCor, and Eko Health. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

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

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

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

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

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

While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.

“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.

Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.

It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
 

The Causes of Quiet Quitting

Potential causes of quiet quitting among PAs and NPs include:

• Unrealistic care expectations. They ask you to give your all to patients, handle everything, and do it all in under 15 minutes since that’s how much time the appointment allows, Ms. Adams said.
• Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
• Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
• Dissatisfaction with pay or working conditions.
• Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”

What Quiet Quitting Looks Like

Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.

“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”

While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”

“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
 

Addressing Quiet Quitting

Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”

Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.

When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”

Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.

*Names have been changed.

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

While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.

“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.

Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.

It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
 

The Causes of Quiet Quitting

Potential causes of quiet quitting among PAs and NPs include:

• Unrealistic care expectations. They ask you to give your all to patients, handle everything, and do it all in under 15 minutes since that’s how much time the appointment allows, Ms. Adams said.
• Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
• Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
• Dissatisfaction with pay or working conditions.
• Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”

What Quiet Quitting Looks Like

Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.

“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”

While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”

“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
 

Addressing Quiet Quitting

Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”

Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.

When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”

Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.

*Names have been changed.

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

While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.

“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.

Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.

It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
 

The Causes of Quiet Quitting

Potential causes of quiet quitting among PAs and NPs include:

• Unrealistic care expectations. They ask you to give your all to patients, handle everything, and do it all in under 15 minutes since that’s how much time the appointment allows, Ms. Adams said.
• Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
• Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
• Dissatisfaction with pay or working conditions.
• Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”

What Quiet Quitting Looks Like

Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.

“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”

While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”

“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
 

Addressing Quiet Quitting

Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”

Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.

When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”

Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.

*Names have been changed.

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