Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

Key clinical point: Three different ketogenic diets (KD)—very-low-calorie ketogenic diet (VLCKD), low-glycemic-index diet (LGID), and 2:1 KD—improved migraine frequency, migraine intensity, and fatigue in patients with chronic and high-frequency episodic migraine.

Major finding: At 3 months, all three KD led to a significant reduction in the fatigue severity scale (FSS) scores, along with reductions in the frequency and intensity of migraine attacks, Migraine Disability Assessment Test (MIDAS) scores, and Headache Impact Test 6 (HIT-6) scores (all P < .001). The mean reduction in FSS had positive correlation with the mean reduction in MIDAS (r = 0.361; P = .002) and HIT-6 (r = 0.344; P = .001) scores.

Study details: This retrospective single-center pilot study included 76 patients with chronic or high-frequency episodic migraine who followed three different KD                                 (VLCKD, LGID, or 2:1 KD) for ≥3 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tereshko Y, Dal Bello S, et al. The effect of three different ketogenic diet protocols on migraine and fatigue in chronic and high-frequency episodic migraine: A pilot study. Nutrients. 2023;15(20):4334 (Oct 11). doi: 10.3390/nu15204334

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

With the help of artificial intelligence (AI), arterial inflammation measured with coronary computed tomography angiography (CCTA) can predict fatal and nonfatal events in patients with nonobstructive coronary artery disease (CAD), according to a study that suggests this approach would change treatment about half the time.

In patients with nonobstructive CAD, CCTA measurement of inflammation on the basis of the Fat Attenuation Index (FAI) “predicts fatal and nonfatal cardiac events independently from clinical risk scores and routine CCTA interpretation,” reported Charalambos Antoniades, MD, PhD, professor of cardiology, Radcliffe Department of Medicine, Oxford, England.

This analysis was based on data from ORFAN, an ongoing study that expects to eventually collect data from 250,000 CCTA. There were multiple goals. The first was to evaluate whether there is a need and a role of CCTA to risk stratify patients without obstructive CAD. A second objective was to evaluate if the FAI inflammation score can quantify residual risk in these patients.

Ted Bosworth/MDedge News

Based on the answers to these questions, the investigators then proceeded to determine if an AI risk model that combines data from the FAI score and risk factors is widely generalizable and, in addition, whether it reclassifies patients in a way meaningful to management.
 

CCTA-based inflammation is promising

The answers to all these questions were yes, according to data presented by Dr. Antoniades in a late-breaker at the American Heart Association scientific sessions.

So far, ORPHAN, which has multiple participating sites in the United Kingdom, Europe, United States, South America, Asia, and Australia, have data on more than 100,000 CCTAs. Approximately 40,000 have been processed. Of these, 82% have had nonobstructive CAD and the remaining obstructive disease.

In long-term follow-up, the numbers of major adverse cardiovascular events (MACE) and cardiac deaths were compared in these two groups. In absolute terms, the nonobstructive CAD group had about twice as many MACE (2,587 vs. 1,450) and cardiac deaths (1,118 vs. 636).

The rate of these events was much lower in the nonobstructive group , which had four times more patients than the obstructive group, but Dr. Antoniades said these data demonstrate substantial rates of events in the nonobstructive group as well as an unmet need to identify and treat risk associated with nonobstructive CAD.

When determining if coronary inflammation as measured with CCTA could be a means identifying risk independent of other factors, the FAI scores were evaluated by quartile in a nested cohort of 3,666 consecutive patients. FAI, which has been validated, is calculated with spatial changes in CCTA-measured perivascular fat composition after standardization for anatomy and other variables.

The discrimination for risk with FAI was impressive. When evaluated across all patients (obstructive or nonobstructive CAD), those in the highest FAI quartile had a hazard ratio (HR) for MACE that was more than six times higher (HR 6.76; P < .001) and a risk of cardiac mortality that was more than 20 times higher (HR 20.20; P < .001) than that of those in the first quartile.

“The prediction was independent of all other risk factors,” Dr. Antoniades reported.
 

Predictive value greater in nonobstructive CAD

When evaluated in nonobstructive disease, the predictive value of FAI was even greater. In obstructive CAD patients, the increased risk of MACE for the fourth relative to the first quartile was increased threefold (HR 3.15; P < .001), but it was increased almost fivefold among those with nonobstructive CAD (HR 4.77; P < .001). The increases for cardiac mortality were fivefold (HR 5.15; P < .001) and more than 10-fold (HR 10.49; P < .001) in these groups, respectively.

When a risk model based on AI that incorporated FAI plus other cardiovascular risk factors was applied retrospectively to the ORPHAN data, the predicted and actual event graph lines were nearly superimposable over a follow-up to 10 years at risk levels ranging from low to very high.

When this inflammation-based AI model was evaluated against standard risk prediction in patients with nonobstructive CAD, 30% of patients were reclassified to a higher risk category and 10% to a lower risk category.

When the AI-risk calculations were provided to clinicians at four hospitals over a recent 1-year period, it resulted “in changes of management in approximately half of patients,” Dr. Antoniades said.

Overall, Dr. Antoniades said these data provide evidence that coronary inflammation is an important driver of residual risk in patients who have nonobstructive CAD on CCTA, and he believes that the AI-enhanced interpretation of the FAI-based inflammatory burden has the potential to become an important management tool.

“AI-risk assessment may transform risk stratification and management of patients undergoing routine CCTA,” Dr. Antoniades said.
 

Imaging has potential for expanded risk assessment

The AHA-invited discussant, Viviany R. Taqueti, MD, director of the cardiac stress laboratory at Brigham and Women’s Hospital, Boston, agreed with the promise of evaluating inflammatory infiltrate in the coronary arteries as well as looking at fat in other tissues, such as skeletal muscle, to better risk stratify patients, but she cautioned about the limitations of conclusions based on observational data.

“A registry is not a randomized trial,” she said.

Characterizing AI as a “black box” in terms of understanding methodology, she also recommended further studies to validate the relative contribution of AI to inflammation alone in risk stratification.

Still, she believes that the “explosive growth” in imaging has created new opportunities for more precisely evaluating cardiovascular risk. She said these might be particularly helpful in the context of the “changing landscape” in CAD driven by less smoking, more obesity, and increased statin use. Overall, she endorsed the basic questions Dr. Antoniades is exploring.

“This is an incredibly intriguing idea that deserves continuing research,” she said.

Dr. Antoniades reported financial relationships with Amarin, AstraZeneca, Caristo Diagnostics, Covance, Mitsubishi Tanabe, MedImmune, Novo Nordisk, Sanofi, and Silence Therapeutics. Dr. Taqueti reported no potential conflicts of interest.

With the help of artificial intelligence (AI), arterial inflammation measured with coronary computed tomography angiography (CCTA) can predict fatal and nonfatal events in patients with nonobstructive coronary artery disease (CAD), according to a study that suggests this approach would change treatment about half the time.

In patients with nonobstructive CAD, CCTA measurement of inflammation on the basis of the Fat Attenuation Index (FAI) “predicts fatal and nonfatal cardiac events independently from clinical risk scores and routine CCTA interpretation,” reported Charalambos Antoniades, MD, PhD, professor of cardiology, Radcliffe Department of Medicine, Oxford, England.

This analysis was based on data from ORFAN, an ongoing study that expects to eventually collect data from 250,000 CCTA. There were multiple goals. The first was to evaluate whether there is a need and a role of CCTA to risk stratify patients without obstructive CAD. A second objective was to evaluate if the FAI inflammation score can quantify residual risk in these patients.

Ted Bosworth/MDedge News

Based on the answers to these questions, the investigators then proceeded to determine if an AI risk model that combines data from the FAI score and risk factors is widely generalizable and, in addition, whether it reclassifies patients in a way meaningful to management.
 

CCTA-based inflammation is promising

The answers to all these questions were yes, according to data presented by Dr. Antoniades in a late-breaker at the American Heart Association scientific sessions.

So far, ORPHAN, which has multiple participating sites in the United Kingdom, Europe, United States, South America, Asia, and Australia, have data on more than 100,000 CCTAs. Approximately 40,000 have been processed. Of these, 82% have had nonobstructive CAD and the remaining obstructive disease.

In long-term follow-up, the numbers of major adverse cardiovascular events (MACE) and cardiac deaths were compared in these two groups. In absolute terms, the nonobstructive CAD group had about twice as many MACE (2,587 vs. 1,450) and cardiac deaths (1,118 vs. 636).

The rate of these events was much lower in the nonobstructive group , which had four times more patients than the obstructive group, but Dr. Antoniades said these data demonstrate substantial rates of events in the nonobstructive group as well as an unmet need to identify and treat risk associated with nonobstructive CAD.

When determining if coronary inflammation as measured with CCTA could be a means identifying risk independent of other factors, the FAI scores were evaluated by quartile in a nested cohort of 3,666 consecutive patients. FAI, which has been validated, is calculated with spatial changes in CCTA-measured perivascular fat composition after standardization for anatomy and other variables.

The discrimination for risk with FAI was impressive. When evaluated across all patients (obstructive or nonobstructive CAD), those in the highest FAI quartile had a hazard ratio (HR) for MACE that was more than six times higher (HR 6.76; P < .001) and a risk of cardiac mortality that was more than 20 times higher (HR 20.20; P < .001) than that of those in the first quartile.

“The prediction was independent of all other risk factors,” Dr. Antoniades reported.
 

Predictive value greater in nonobstructive CAD

When evaluated in nonobstructive disease, the predictive value of FAI was even greater. In obstructive CAD patients, the increased risk of MACE for the fourth relative to the first quartile was increased threefold (HR 3.15; P < .001), but it was increased almost fivefold among those with nonobstructive CAD (HR 4.77; P < .001). The increases for cardiac mortality were fivefold (HR 5.15; P < .001) and more than 10-fold (HR 10.49; P < .001) in these groups, respectively.

When a risk model based on AI that incorporated FAI plus other cardiovascular risk factors was applied retrospectively to the ORPHAN data, the predicted and actual event graph lines were nearly superimposable over a follow-up to 10 years at risk levels ranging from low to very high.

When this inflammation-based AI model was evaluated against standard risk prediction in patients with nonobstructive CAD, 30% of patients were reclassified to a higher risk category and 10% to a lower risk category.

When the AI-risk calculations were provided to clinicians at four hospitals over a recent 1-year period, it resulted “in changes of management in approximately half of patients,” Dr. Antoniades said.

Overall, Dr. Antoniades said these data provide evidence that coronary inflammation is an important driver of residual risk in patients who have nonobstructive CAD on CCTA, and he believes that the AI-enhanced interpretation of the FAI-based inflammatory burden has the potential to become an important management tool.

“AI-risk assessment may transform risk stratification and management of patients undergoing routine CCTA,” Dr. Antoniades said.
 

Imaging has potential for expanded risk assessment

The AHA-invited discussant, Viviany R. Taqueti, MD, director of the cardiac stress laboratory at Brigham and Women’s Hospital, Boston, agreed with the promise of evaluating inflammatory infiltrate in the coronary arteries as well as looking at fat in other tissues, such as skeletal muscle, to better risk stratify patients, but she cautioned about the limitations of conclusions based on observational data.

“A registry is not a randomized trial,” she said.

Characterizing AI as a “black box” in terms of understanding methodology, she also recommended further studies to validate the relative contribution of AI to inflammation alone in risk stratification.

Still, she believes that the “explosive growth” in imaging has created new opportunities for more precisely evaluating cardiovascular risk. She said these might be particularly helpful in the context of the “changing landscape” in CAD driven by less smoking, more obesity, and increased statin use. Overall, she endorsed the basic questions Dr. Antoniades is exploring.

“This is an incredibly intriguing idea that deserves continuing research,” she said.

Dr. Antoniades reported financial relationships with Amarin, AstraZeneca, Caristo Diagnostics, Covance, Mitsubishi Tanabe, MedImmune, Novo Nordisk, Sanofi, and Silence Therapeutics. Dr. Taqueti reported no potential conflicts of interest.

With the help of artificial intelligence (AI), arterial inflammation measured with coronary computed tomography angiography (CCTA) can predict fatal and nonfatal events in patients with nonobstructive coronary artery disease (CAD), according to a study that suggests this approach would change treatment about half the time.

In patients with nonobstructive CAD, CCTA measurement of inflammation on the basis of the Fat Attenuation Index (FAI) “predicts fatal and nonfatal cardiac events independently from clinical risk scores and routine CCTA interpretation,” reported Charalambos Antoniades, MD, PhD, professor of cardiology, Radcliffe Department of Medicine, Oxford, England.

This analysis was based on data from ORFAN, an ongoing study that expects to eventually collect data from 250,000 CCTA. There were multiple goals. The first was to evaluate whether there is a need and a role of CCTA to risk stratify patients without obstructive CAD. A second objective was to evaluate if the FAI inflammation score can quantify residual risk in these patients.

Ted Bosworth/MDedge News

Based on the answers to these questions, the investigators then proceeded to determine if an AI risk model that combines data from the FAI score and risk factors is widely generalizable and, in addition, whether it reclassifies patients in a way meaningful to management.
 

CCTA-based inflammation is promising

The answers to all these questions were yes, according to data presented by Dr. Antoniades in a late-breaker at the American Heart Association scientific sessions.

So far, ORPHAN, which has multiple participating sites in the United Kingdom, Europe, United States, South America, Asia, and Australia, have data on more than 100,000 CCTAs. Approximately 40,000 have been processed. Of these, 82% have had nonobstructive CAD and the remaining obstructive disease.

In long-term follow-up, the numbers of major adverse cardiovascular events (MACE) and cardiac deaths were compared in these two groups. In absolute terms, the nonobstructive CAD group had about twice as many MACE (2,587 vs. 1,450) and cardiac deaths (1,118 vs. 636).

The rate of these events was much lower in the nonobstructive group , which had four times more patients than the obstructive group, but Dr. Antoniades said these data demonstrate substantial rates of events in the nonobstructive group as well as an unmet need to identify and treat risk associated with nonobstructive CAD.

When determining if coronary inflammation as measured with CCTA could be a means identifying risk independent of other factors, the FAI scores were evaluated by quartile in a nested cohort of 3,666 consecutive patients. FAI, which has been validated, is calculated with spatial changes in CCTA-measured perivascular fat composition after standardization for anatomy and other variables.

The discrimination for risk with FAI was impressive. When evaluated across all patients (obstructive or nonobstructive CAD), those in the highest FAI quartile had a hazard ratio (HR) for MACE that was more than six times higher (HR 6.76; P < .001) and a risk of cardiac mortality that was more than 20 times higher (HR 20.20; P < .001) than that of those in the first quartile.

“The prediction was independent of all other risk factors,” Dr. Antoniades reported.
 

Predictive value greater in nonobstructive CAD

When evaluated in nonobstructive disease, the predictive value of FAI was even greater. In obstructive CAD patients, the increased risk of MACE for the fourth relative to the first quartile was increased threefold (HR 3.15; P < .001), but it was increased almost fivefold among those with nonobstructive CAD (HR 4.77; P < .001). The increases for cardiac mortality were fivefold (HR 5.15; P < .001) and more than 10-fold (HR 10.49; P < .001) in these groups, respectively.

When a risk model based on AI that incorporated FAI plus other cardiovascular risk factors was applied retrospectively to the ORPHAN data, the predicted and actual event graph lines were nearly superimposable over a follow-up to 10 years at risk levels ranging from low to very high.

When this inflammation-based AI model was evaluated against standard risk prediction in patients with nonobstructive CAD, 30% of patients were reclassified to a higher risk category and 10% to a lower risk category.

When the AI-risk calculations were provided to clinicians at four hospitals over a recent 1-year period, it resulted “in changes of management in approximately half of patients,” Dr. Antoniades said.

Overall, Dr. Antoniades said these data provide evidence that coronary inflammation is an important driver of residual risk in patients who have nonobstructive CAD on CCTA, and he believes that the AI-enhanced interpretation of the FAI-based inflammatory burden has the potential to become an important management tool.

“AI-risk assessment may transform risk stratification and management of patients undergoing routine CCTA,” Dr. Antoniades said.
 

Imaging has potential for expanded risk assessment

The AHA-invited discussant, Viviany R. Taqueti, MD, director of the cardiac stress laboratory at Brigham and Women’s Hospital, Boston, agreed with the promise of evaluating inflammatory infiltrate in the coronary arteries as well as looking at fat in other tissues, such as skeletal muscle, to better risk stratify patients, but she cautioned about the limitations of conclusions based on observational data.

“A registry is not a randomized trial,” she said.

Characterizing AI as a “black box” in terms of understanding methodology, she also recommended further studies to validate the relative contribution of AI to inflammation alone in risk stratification.

Still, she believes that the “explosive growth” in imaging has created new opportunities for more precisely evaluating cardiovascular risk. She said these might be particularly helpful in the context of the “changing landscape” in CAD driven by less smoking, more obesity, and increased statin use. Overall, she endorsed the basic questions Dr. Antoniades is exploring.

“This is an incredibly intriguing idea that deserves continuing research,” she said.

Dr. Antoniades reported financial relationships with Amarin, AstraZeneca, Caristo Diagnostics, Covance, Mitsubishi Tanabe, MedImmune, Novo Nordisk, Sanofi, and Silence Therapeutics. Dr. Taqueti reported no potential conflicts of interest.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.

SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.

Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.

Lucy Hicks/Medscape Medical News

While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.

Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”

Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.

Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.

Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.

“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.

In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.

Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.

These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.

The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”

Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.

“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

Screening with a “smart,” artificial-intelligence (AI)–enhanced investigational digital stethoscope (Eko Duo) that provides phonocardiogram and electrocardiogram (ECG) readings doubled the detection of peripartum cardiomyopathy in a large study of obstetric patients in Nigeria.

Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.

“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”

If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.

Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.

“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.

Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.

“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.

This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.

Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.

A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
 

Findings ‘absolutely startling’

The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”

Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.

“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.

“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”

“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.

The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.

With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.

“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?

“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”

However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.

Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.

“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
 

AI-guided screening study

Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.

In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.

The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).

In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.

In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.

The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.

The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).

For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.

Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.

A version of this article appeared on Medscape.com.

TOPLINE:

Converting late cancellations and no-show appointments to telemedicine visits increases access to care without the need for rescheduling, according to new research.

METHODOLOGY:

• Investigators identified adult rheumatology patients with late cancellations (within 24 hours of appointment) or impending no-show appointments from September 2020 to March 2023.
• These patients were contacted and were offered the option of converting their in-person appointment to a telemedicine visit, either by phone or video.
• The program was piloted at one clinic beginning Sept. 1, 2020, and was expanded to a second clinic on Sept. 1, 2021.

TAKEAWAY:

• Of 624 eligible visits, 516 (83%) were converted to telehealth visits. Phone visits were slightly more popular than video visits (54% vs. 46%, respectively).
• Patients who were older, who lived in a rural area, or who were on Medicare and Medicaid were more likely to opt for phone visits.
• The intervention resulted in an additional 258 hours of patient care.
• The reduction in lost revenue for phone versus video telemedicine visits was $7,298 ($39.19 per appointment).

IN PRACTICE:

“Our simple, targeted strategy of converting appointments to telehealth when an in-person appointment is identified as at-risk resulted in significant access gains and modest revenue loss reduction,” with net gains overall, the authors write.

SOURCE:

Sancia Ferguson MD, MPH, of the University of Wisconsin-Madison School of Medicine, presented the research at the annual meeting of the American College of Rheumatology, abstract 1007.

LIMITATIONS:

The study was conducted at two clinics in the UW Health system and may not be implementable in smaller practices.

DISCLOSURES:

Senior author Christie Bartels, MD, also of University of Washington-Madison School of Medicine, reports receiving a research grant from Pfizer unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Converting late cancellations and no-show appointments to telemedicine visits increases access to care without the need for rescheduling, according to new research.

METHODOLOGY:

• Investigators identified adult rheumatology patients with late cancellations (within 24 hours of appointment) or impending no-show appointments from September 2020 to March 2023.
• These patients were contacted and were offered the option of converting their in-person appointment to a telemedicine visit, either by phone or video.
• The program was piloted at one clinic beginning Sept. 1, 2020, and was expanded to a second clinic on Sept. 1, 2021.

TAKEAWAY:

• Of 624 eligible visits, 516 (83%) were converted to telehealth visits. Phone visits were slightly more popular than video visits (54% vs. 46%, respectively).
• Patients who were older, who lived in a rural area, or who were on Medicare and Medicaid were more likely to opt for phone visits.
• The intervention resulted in an additional 258 hours of patient care.
• The reduction in lost revenue for phone versus video telemedicine visits was $7,298 ($39.19 per appointment).

IN PRACTICE:

“Our simple, targeted strategy of converting appointments to telehealth when an in-person appointment is identified as at-risk resulted in significant access gains and modest revenue loss reduction,” with net gains overall, the authors write.

SOURCE:

Sancia Ferguson MD, MPH, of the University of Wisconsin-Madison School of Medicine, presented the research at the annual meeting of the American College of Rheumatology, abstract 1007.

LIMITATIONS:

The study was conducted at two clinics in the UW Health system and may not be implementable in smaller practices.

DISCLOSURES:

Senior author Christie Bartels, MD, also of University of Washington-Madison School of Medicine, reports receiving a research grant from Pfizer unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Converting late cancellations and no-show appointments to telemedicine visits increases access to care without the need for rescheduling, according to new research.

METHODOLOGY:

• Investigators identified adult rheumatology patients with late cancellations (within 24 hours of appointment) or impending no-show appointments from September 2020 to March 2023.
• These patients were contacted and were offered the option of converting their in-person appointment to a telemedicine visit, either by phone or video.
• The program was piloted at one clinic beginning Sept. 1, 2020, and was expanded to a second clinic on Sept. 1, 2021.

TAKEAWAY:

• Of 624 eligible visits, 516 (83%) were converted to telehealth visits. Phone visits were slightly more popular than video visits (54% vs. 46%, respectively).
• Patients who were older, who lived in a rural area, or who were on Medicare and Medicaid were more likely to opt for phone visits.
• The intervention resulted in an additional 258 hours of patient care.
• The reduction in lost revenue for phone versus video telemedicine visits was $7,298 ($39.19 per appointment).

IN PRACTICE:

“Our simple, targeted strategy of converting appointments to telehealth when an in-person appointment is identified as at-risk resulted in significant access gains and modest revenue loss reduction,” with net gains overall, the authors write.

SOURCE:

Sancia Ferguson MD, MPH, of the University of Wisconsin-Madison School of Medicine, presented the research at the annual meeting of the American College of Rheumatology, abstract 1007.

LIMITATIONS:

The study was conducted at two clinics in the UW Health system and may not be implementable in smaller practices.

DISCLOSURES:

Senior author Christie Bartels, MD, also of University of Washington-Madison School of Medicine, reports receiving a research grant from Pfizer unrelated to this study.

A version of this article appeared on Medscape.com.

PHILADELPHIA – A carefully tailored program in which physicians talked with heart failure (HF) patients about the cost of their medications improved medication adherence and the likelihood that patients get the medications they’re prescribed, results of a pilot study show.

The POCKET-COST-HF trial integrated information about patient-specific out-of-pocket (OOP) drug costs into clinical encounters between cardiologists and patients with heart failure with reduced ejection fraction (HFrEF) at six clinic sites in two different health systems. Neil W. Dickert, MD, PhD, primary investigator of the trial, said OOP costs for HFrEF patients with Medicare Part D prescription drug coverage can run upwards of $2,600 a year for four-drug therapy. Dr. Dickert is a cardiologist at Emory University in Atlanta.

“The primary outcome for the study was whether patients and clinicians essentially talked about the cost of medications,” Dr. Dickert said in an interview. “The study was positive in that perspective; we saw an increase of about 19% in the encounters that had cost conversations related to heart failure medication.”

The trial, which Dr. Dickert presented at the annual scientific sessions of the American Heart Association, was designed to evaluate the effect of patient-specific OOP costs in the shared decision-making about heart failure medications, Dr. Dickert said.

The primary outcome was cost-informed decision-making, achieved in 68% of the intervention group encounters and 49% of control encounters (P = .021).
 

Fewer in-pharmacy adjustments

“We saw some really interesting signals of potential benefits in the space of actual decisions,” he said. “There were fewer, for example, contingency plans made in the intervention arm versus the control arm, and what that means is physicians were less likely to write a prescription and leave the decision about whether or not it’s worth it to the patient when they get to the pharmacy.”

The study intervention was a checklist of 19 heart failure medications that included OOP cost, ranging from minimal costs for generics such as diuretics and beta blockers to $617 for dapagliflozin. The checklist was based on an electronic medical records HF medications checklist. Researchers obtained drug cost estimates from TailorMed, a financial navigation company.

Six clinic sites within two health systems, one in Georgia, the other in Colorado, participated in the study. Each cluster had 40 or so patients (n = 247) randomized to the intervention or control. About two-thirds were White, a quarter were Black and 4% and 2.5% in the control and intervention group were Hispanic/LatinX. Income ranges were similar across both arms.

For the study intervention, patients got a call from the clinic 2-3 weeks before their scheduled visit to obtain verbal consent to participate and their OOP costs for drugs. The visit itself, where patients randomized to the intervention received the checklist, was audio recorded. After the visit, patients took a follow-up telephone survey, then the clinic staff did an electronic health record 3 months after the visit.

Getting the patient drug price information was not easy, Dr. Dickert said. “It required a fair amount of work and a big list to get that information that we could then populate the checklist for people,” he said. “It was a behind-the-scenes thing that is not necessarily scalable as done.”

Dr. Dickert acknowledged an increasing emphasis on price transparency in medicine, but the trade-offs are unknown. “Depending upon how that’s carried out, that can have different implications,” he said. “I’m a believer that if we think good communication has the ability to enhance medical decision-making, it also means that either bad information or bad communication can undermine.

“So, I think it’s really important to study these interventions and to do them in rigorous ways where we can really get a sense of what kind of impact they have on patients and clinicians.”
 

Study strengths and limitations

Discussant Dhruv Kazi, MD, director of the cardiac critical care unit at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School, both in Boston, said in an interview that this study fulfills an important function in investigating how OOP costs influence medication adherence in HFrEF patients.

“The total cost of drugs has often been a focus of policy discussions,” he said. “We talk about, how do we reduce drug costs?” He noted the Inflation Reduction Act will bring some of these drug costs down.

“On the flip side,” he added, “as a community we pay less attention to out-of-pocket costs because we assume those are not in our control, yet what the patient cares about is not the total cost of the drug, but, ‘What am I going to pay this month, and what am I going to pay cumulatively over the course of the year? Can I even afford this drug?”

POCKET-COST-HF provided a sound basis for making that investigation, he said, adding that its multisite design and mixed-methods approach – patient contact before and after visits and recording of encounters – are strengths. “Just looking at the logistics involved in pulling off something like this, the study investigators deserve to be congratulated,” he said.

One limitation, Dr. Kazi said, is its exclusion of non–English speakers. Adding them in, along with testing the intervention in community, rural, and primary care settings, are future goals for the intervention, he said. Within the trial itself, examining the cost-effectiveness of the intervention would be laudable, Dr. Kazi said.

The Agency for Healthcare Research and Quality funded the trial. Dr. Dickert disclosed relationships with Abiomed. Dr. Kazi has no relevant relationships to disclose.

PHILADELPHIA – A carefully tailored program in which physicians talked with heart failure (HF) patients about the cost of their medications improved medication adherence and the likelihood that patients get the medications they’re prescribed, results of a pilot study show.

The POCKET-COST-HF trial integrated information about patient-specific out-of-pocket (OOP) drug costs into clinical encounters between cardiologists and patients with heart failure with reduced ejection fraction (HFrEF) at six clinic sites in two different health systems. Neil W. Dickert, MD, PhD, primary investigator of the trial, said OOP costs for HFrEF patients with Medicare Part D prescription drug coverage can run upwards of $2,600 a year for four-drug therapy. Dr. Dickert is a cardiologist at Emory University in Atlanta.

“The primary outcome for the study was whether patients and clinicians essentially talked about the cost of medications,” Dr. Dickert said in an interview. “The study was positive in that perspective; we saw an increase of about 19% in the encounters that had cost conversations related to heart failure medication.”

The trial, which Dr. Dickert presented at the annual scientific sessions of the American Heart Association, was designed to evaluate the effect of patient-specific OOP costs in the shared decision-making about heart failure medications, Dr. Dickert said.

The primary outcome was cost-informed decision-making, achieved in 68% of the intervention group encounters and 49% of control encounters (P = .021).
 

Fewer in-pharmacy adjustments

“We saw some really interesting signals of potential benefits in the space of actual decisions,” he said. “There were fewer, for example, contingency plans made in the intervention arm versus the control arm, and what that means is physicians were less likely to write a prescription and leave the decision about whether or not it’s worth it to the patient when they get to the pharmacy.”

The study intervention was a checklist of 19 heart failure medications that included OOP cost, ranging from minimal costs for generics such as diuretics and beta blockers to $617 for dapagliflozin. The checklist was based on an electronic medical records HF medications checklist. Researchers obtained drug cost estimates from TailorMed, a financial navigation company.

Six clinic sites within two health systems, one in Georgia, the other in Colorado, participated in the study. Each cluster had 40 or so patients (n = 247) randomized to the intervention or control. About two-thirds were White, a quarter were Black and 4% and 2.5% in the control and intervention group were Hispanic/LatinX. Income ranges were similar across both arms.

For the study intervention, patients got a call from the clinic 2-3 weeks before their scheduled visit to obtain verbal consent to participate and their OOP costs for drugs. The visit itself, where patients randomized to the intervention received the checklist, was audio recorded. After the visit, patients took a follow-up telephone survey, then the clinic staff did an electronic health record 3 months after the visit.

Getting the patient drug price information was not easy, Dr. Dickert said. “It required a fair amount of work and a big list to get that information that we could then populate the checklist for people,” he said. “It was a behind-the-scenes thing that is not necessarily scalable as done.”

Dr. Dickert acknowledged an increasing emphasis on price transparency in medicine, but the trade-offs are unknown. “Depending upon how that’s carried out, that can have different implications,” he said. “I’m a believer that if we think good communication has the ability to enhance medical decision-making, it also means that either bad information or bad communication can undermine.

“So, I think it’s really important to study these interventions and to do them in rigorous ways where we can really get a sense of what kind of impact they have on patients and clinicians.”
 

Study strengths and limitations

Discussant Dhruv Kazi, MD, director of the cardiac critical care unit at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School, both in Boston, said in an interview that this study fulfills an important function in investigating how OOP costs influence medication adherence in HFrEF patients.

“The total cost of drugs has often been a focus of policy discussions,” he said. “We talk about, how do we reduce drug costs?” He noted the Inflation Reduction Act will bring some of these drug costs down.

“On the flip side,” he added, “as a community we pay less attention to out-of-pocket costs because we assume those are not in our control, yet what the patient cares about is not the total cost of the drug, but, ‘What am I going to pay this month, and what am I going to pay cumulatively over the course of the year? Can I even afford this drug?”

POCKET-COST-HF provided a sound basis for making that investigation, he said, adding that its multisite design and mixed-methods approach – patient contact before and after visits and recording of encounters – are strengths. “Just looking at the logistics involved in pulling off something like this, the study investigators deserve to be congratulated,” he said.

One limitation, Dr. Kazi said, is its exclusion of non–English speakers. Adding them in, along with testing the intervention in community, rural, and primary care settings, are future goals for the intervention, he said. Within the trial itself, examining the cost-effectiveness of the intervention would be laudable, Dr. Kazi said.

The Agency for Healthcare Research and Quality funded the trial. Dr. Dickert disclosed relationships with Abiomed. Dr. Kazi has no relevant relationships to disclose.

PHILADELPHIA – A carefully tailored program in which physicians talked with heart failure (HF) patients about the cost of their medications improved medication adherence and the likelihood that patients get the medications they’re prescribed, results of a pilot study show.

The POCKET-COST-HF trial integrated information about patient-specific out-of-pocket (OOP) drug costs into clinical encounters between cardiologists and patients with heart failure with reduced ejection fraction (HFrEF) at six clinic sites in two different health systems. Neil W. Dickert, MD, PhD, primary investigator of the trial, said OOP costs for HFrEF patients with Medicare Part D prescription drug coverage can run upwards of $2,600 a year for four-drug therapy. Dr. Dickert is a cardiologist at Emory University in Atlanta.

“The primary outcome for the study was whether patients and clinicians essentially talked about the cost of medications,” Dr. Dickert said in an interview. “The study was positive in that perspective; we saw an increase of about 19% in the encounters that had cost conversations related to heart failure medication.”

The trial, which Dr. Dickert presented at the annual scientific sessions of the American Heart Association, was designed to evaluate the effect of patient-specific OOP costs in the shared decision-making about heart failure medications, Dr. Dickert said.

The primary outcome was cost-informed decision-making, achieved in 68% of the intervention group encounters and 49% of control encounters (P = .021).
 

Fewer in-pharmacy adjustments

“We saw some really interesting signals of potential benefits in the space of actual decisions,” he said. “There were fewer, for example, contingency plans made in the intervention arm versus the control arm, and what that means is physicians were less likely to write a prescription and leave the decision about whether or not it’s worth it to the patient when they get to the pharmacy.”

The study intervention was a checklist of 19 heart failure medications that included OOP cost, ranging from minimal costs for generics such as diuretics and beta blockers to $617 for dapagliflozin. The checklist was based on an electronic medical records HF medications checklist. Researchers obtained drug cost estimates from TailorMed, a financial navigation company.

Six clinic sites within two health systems, one in Georgia, the other in Colorado, participated in the study. Each cluster had 40 or so patients (n = 247) randomized to the intervention or control. About two-thirds were White, a quarter were Black and 4% and 2.5% in the control and intervention group were Hispanic/LatinX. Income ranges were similar across both arms.

For the study intervention, patients got a call from the clinic 2-3 weeks before their scheduled visit to obtain verbal consent to participate and their OOP costs for drugs. The visit itself, where patients randomized to the intervention received the checklist, was audio recorded. After the visit, patients took a follow-up telephone survey, then the clinic staff did an electronic health record 3 months after the visit.

Getting the patient drug price information was not easy, Dr. Dickert said. “It required a fair amount of work and a big list to get that information that we could then populate the checklist for people,” he said. “It was a behind-the-scenes thing that is not necessarily scalable as done.”

Dr. Dickert acknowledged an increasing emphasis on price transparency in medicine, but the trade-offs are unknown. “Depending upon how that’s carried out, that can have different implications,” he said. “I’m a believer that if we think good communication has the ability to enhance medical decision-making, it also means that either bad information or bad communication can undermine.

“So, I think it’s really important to study these interventions and to do them in rigorous ways where we can really get a sense of what kind of impact they have on patients and clinicians.”
 

Study strengths and limitations

Discussant Dhruv Kazi, MD, director of the cardiac critical care unit at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School, both in Boston, said in an interview that this study fulfills an important function in investigating how OOP costs influence medication adherence in HFrEF patients.

“The total cost of drugs has often been a focus of policy discussions,” he said. “We talk about, how do we reduce drug costs?” He noted the Inflation Reduction Act will bring some of these drug costs down.

“On the flip side,” he added, “as a community we pay less attention to out-of-pocket costs because we assume those are not in our control, yet what the patient cares about is not the total cost of the drug, but, ‘What am I going to pay this month, and what am I going to pay cumulatively over the course of the year? Can I even afford this drug?”

POCKET-COST-HF provided a sound basis for making that investigation, he said, adding that its multisite design and mixed-methods approach – patient contact before and after visits and recording of encounters – are strengths. “Just looking at the logistics involved in pulling off something like this, the study investigators deserve to be congratulated,” he said.

One limitation, Dr. Kazi said, is its exclusion of non–English speakers. Adding them in, along with testing the intervention in community, rural, and primary care settings, are future goals for the intervention, he said. Within the trial itself, examining the cost-effectiveness of the intervention would be laudable, Dr. Kazi said.

The Agency for Healthcare Research and Quality funded the trial. Dr. Dickert disclosed relationships with Abiomed. Dr. Kazi has no relevant relationships to disclose.

As many as 87% of patients experience symptoms after COVID-19 infection that last 2 months or more, one of the most common being chest pain. And chronic chest discomfort may persist in some individuals for years after COVID, warranting future studies of reliable treatments and pain management in this population, a new study shows.

“Recent studies have shown that chest pain occurs in as many as 89% of patients who qualify as having long COVID,” said Ansley Poole, an undergraduate student at the University of South Florida, Tampa, who conducted the research under the supervision of Christine Hunt, DO, and her colleagues at Mayo Clinic, Jacksonville, Fla.

The findings, though preliminary, shed light on the prevalence, current treatments, and ongoing challenges in managing symptoms of long COVID, said Ms. Poole, who presented the research at the annual Pain Medicine Meeting sponsored by the American Society of Regional Anesthesia and Pain Medicine.

Long COVID, which affects an estimated 18 million Americans, manifests approximately 12 weeks after the initial infection and can persist for 2 months or more. Ms. Poole and her team set out to identify risk factors, treatment options, and outcomes for patients dealing with post-COVID chest discomfort.

The study involved a retrospective chart review of 520 patients from the Mayo Clinic network, narrowed down to a final sample of 104. To be included, patients had to report chest discomfort 3-6 months post COVID that continued for 3-6 months after presentation, with no history of chronic chest pain before the infection.

The researchers identified no standardized method for the treatment or management of chest pain linked to long COVID. “Patients were prescribed multiple different treatments, including opioids, post-COVID treatment programs, anticoagulants, steroids, and even psychological programs,” Ms. Poole said.

The median age of the patients was around 50 years; more than 65% were female and over 90% identified as White. More than half (55%) had received one or more vaccine doses at the time of infection. The majority were classified as overweight or obese at the time of their SARS-CoV-2 infection.

Of the 104 patients analyzed, 30 were referred to one or more subspecialties within the pain medicine department, 23 were hospitalized, and 9 were admitted to the intensive care unit or critical care.

“Fifty-three of our patients visited the ER one or more times after COVID because of chest discomfort; however, only six were admitted for over 24 hours, indicating possible overuse of emergency services,” Ms. Poole noted.

Overall, chest pain was described as intermittent instead of constant, which may have been a barrier to providing adequate and timely treatment. The inconsistent presence of pain contributed to the prolonged suffering some patients experienced, Ms. Poole noted.

The study identified several comorbidities, potentially complicating the treatment and etiology of chest pain. These comorbidities – when combined with COVID-related chest pain – contributed to the wide array of prescribed treatments, including steroids, anticoagulants, beta blockers, and physical therapy. Chest pain also seldom stood alone; it was often accompanied by other long COVID–related symptoms, such as shortness of breath.

“Our current analysis indicates that chest pain continues on for years in many individuals, suggesting that COVID-related chest pain may be resistant to treatment,” Ms. Poole reported.

The observed heterogeneity in treatments and outcomes in patients experiencing long-term chest discomfort after COVID infection underscores the need for future studies to establish reliable treatment and management protocols for this population, said Dalia Elmofty, MD, an associate professor of anesthesia and critical care at the University of Chicago, who was not involved in the study. “There are things about COVID that we don’t fully understand. As we’re seeing its consequences and trying to understand its etiology, we recognize the need for further research,” Dr. Elmofty said.

“So many different disease pathologies came out of COVID, whether it’s organ pathology, myofascial pathology, or autoimmune pathology, and all of that is obviously linked to pain,” Dr. Elmofty told this news organization. “It’s an area of research that we are going to have to devote a lot of time to in order to understand, but I think we’re still in the very early phases, trying to fit the pieces of the puzzle together.”

Ms. Poole and Dr. Elmofty report no relevant financial relationships.

A version of this article appeared on Medscape.com.

As many as 87% of patients experience symptoms after COVID-19 infection that last 2 months or more, one of the most common being chest pain. And chronic chest discomfort may persist in some individuals for years after COVID, warranting future studies of reliable treatments and pain management in this population, a new study shows.

“Recent studies have shown that chest pain occurs in as many as 89% of patients who qualify as having long COVID,” said Ansley Poole, an undergraduate student at the University of South Florida, Tampa, who conducted the research under the supervision of Christine Hunt, DO, and her colleagues at Mayo Clinic, Jacksonville, Fla.

The findings, though preliminary, shed light on the prevalence, current treatments, and ongoing challenges in managing symptoms of long COVID, said Ms. Poole, who presented the research at the annual Pain Medicine Meeting sponsored by the American Society of Regional Anesthesia and Pain Medicine.

Long COVID, which affects an estimated 18 million Americans, manifests approximately 12 weeks after the initial infection and can persist for 2 months or more. Ms. Poole and her team set out to identify risk factors, treatment options, and outcomes for patients dealing with post-COVID chest discomfort.

The study involved a retrospective chart review of 520 patients from the Mayo Clinic network, narrowed down to a final sample of 104. To be included, patients had to report chest discomfort 3-6 months post COVID that continued for 3-6 months after presentation, with no history of chronic chest pain before the infection.

The researchers identified no standardized method for the treatment or management of chest pain linked to long COVID. “Patients were prescribed multiple different treatments, including opioids, post-COVID treatment programs, anticoagulants, steroids, and even psychological programs,” Ms. Poole said.

The median age of the patients was around 50 years; more than 65% were female and over 90% identified as White. More than half (55%) had received one or more vaccine doses at the time of infection. The majority were classified as overweight or obese at the time of their SARS-CoV-2 infection.

Of the 104 patients analyzed, 30 were referred to one or more subspecialties within the pain medicine department, 23 were hospitalized, and 9 were admitted to the intensive care unit or critical care.

“Fifty-three of our patients visited the ER one or more times after COVID because of chest discomfort; however, only six were admitted for over 24 hours, indicating possible overuse of emergency services,” Ms. Poole noted.

Overall, chest pain was described as intermittent instead of constant, which may have been a barrier to providing adequate and timely treatment. The inconsistent presence of pain contributed to the prolonged suffering some patients experienced, Ms. Poole noted.

The study identified several comorbidities, potentially complicating the treatment and etiology of chest pain. These comorbidities – when combined with COVID-related chest pain – contributed to the wide array of prescribed treatments, including steroids, anticoagulants, beta blockers, and physical therapy. Chest pain also seldom stood alone; it was often accompanied by other long COVID–related symptoms, such as shortness of breath.

“Our current analysis indicates that chest pain continues on for years in many individuals, suggesting that COVID-related chest pain may be resistant to treatment,” Ms. Poole reported.

The observed heterogeneity in treatments and outcomes in patients experiencing long-term chest discomfort after COVID infection underscores the need for future studies to establish reliable treatment and management protocols for this population, said Dalia Elmofty, MD, an associate professor of anesthesia and critical care at the University of Chicago, who was not involved in the study. “There are things about COVID that we don’t fully understand. As we’re seeing its consequences and trying to understand its etiology, we recognize the need for further research,” Dr. Elmofty said.

“So many different disease pathologies came out of COVID, whether it’s organ pathology, myofascial pathology, or autoimmune pathology, and all of that is obviously linked to pain,” Dr. Elmofty told this news organization. “It’s an area of research that we are going to have to devote a lot of time to in order to understand, but I think we’re still in the very early phases, trying to fit the pieces of the puzzle together.”

Ms. Poole and Dr. Elmofty report no relevant financial relationships.

A version of this article appeared on Medscape.com.

As many as 87% of patients experience symptoms after COVID-19 infection that last 2 months or more, one of the most common being chest pain. And chronic chest discomfort may persist in some individuals for years after COVID, warranting future studies of reliable treatments and pain management in this population, a new study shows.

“Recent studies have shown that chest pain occurs in as many as 89% of patients who qualify as having long COVID,” said Ansley Poole, an undergraduate student at the University of South Florida, Tampa, who conducted the research under the supervision of Christine Hunt, DO, and her colleagues at Mayo Clinic, Jacksonville, Fla.

The findings, though preliminary, shed light on the prevalence, current treatments, and ongoing challenges in managing symptoms of long COVID, said Ms. Poole, who presented the research at the annual Pain Medicine Meeting sponsored by the American Society of Regional Anesthesia and Pain Medicine.

Long COVID, which affects an estimated 18 million Americans, manifests approximately 12 weeks after the initial infection and can persist for 2 months or more. Ms. Poole and her team set out to identify risk factors, treatment options, and outcomes for patients dealing with post-COVID chest discomfort.

The study involved a retrospective chart review of 520 patients from the Mayo Clinic network, narrowed down to a final sample of 104. To be included, patients had to report chest discomfort 3-6 months post COVID that continued for 3-6 months after presentation, with no history of chronic chest pain before the infection.

The researchers identified no standardized method for the treatment or management of chest pain linked to long COVID. “Patients were prescribed multiple different treatments, including opioids, post-COVID treatment programs, anticoagulants, steroids, and even psychological programs,” Ms. Poole said.

The median age of the patients was around 50 years; more than 65% were female and over 90% identified as White. More than half (55%) had received one or more vaccine doses at the time of infection. The majority were classified as overweight or obese at the time of their SARS-CoV-2 infection.

Of the 104 patients analyzed, 30 were referred to one or more subspecialties within the pain medicine department, 23 were hospitalized, and 9 were admitted to the intensive care unit or critical care.

“Fifty-three of our patients visited the ER one or more times after COVID because of chest discomfort; however, only six were admitted for over 24 hours, indicating possible overuse of emergency services,” Ms. Poole noted.

Overall, chest pain was described as intermittent instead of constant, which may have been a barrier to providing adequate and timely treatment. The inconsistent presence of pain contributed to the prolonged suffering some patients experienced, Ms. Poole noted.

The study identified several comorbidities, potentially complicating the treatment and etiology of chest pain. These comorbidities – when combined with COVID-related chest pain – contributed to the wide array of prescribed treatments, including steroids, anticoagulants, beta blockers, and physical therapy. Chest pain also seldom stood alone; it was often accompanied by other long COVID–related symptoms, such as shortness of breath.

“Our current analysis indicates that chest pain continues on for years in many individuals, suggesting that COVID-related chest pain may be resistant to treatment,” Ms. Poole reported.

The observed heterogeneity in treatments and outcomes in patients experiencing long-term chest discomfort after COVID infection underscores the need for future studies to establish reliable treatment and management protocols for this population, said Dalia Elmofty, MD, an associate professor of anesthesia and critical care at the University of Chicago, who was not involved in the study. “There are things about COVID that we don’t fully understand. As we’re seeing its consequences and trying to understand its etiology, we recognize the need for further research,” Dr. Elmofty said.

“So many different disease pathologies came out of COVID, whether it’s organ pathology, myofascial pathology, or autoimmune pathology, and all of that is obviously linked to pain,” Dr. Elmofty told this news organization. “It’s an area of research that we are going to have to devote a lot of time to in order to understand, but I think we’re still in the very early phases, trying to fit the pieces of the puzzle together.”

Ms. Poole and Dr. Elmofty report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Excess consumption of red meat, whether processed or not, is linked to a greater risk for developing type 2 diabetes. This association was confirmed by a new study published in the American Journal of Clinical Nutrition, a data analysis of nearly 217,000 people who were monitored for three decades as part of several cohort studies. “Our study supports the current dietary recommendations of limiting consumption of red meat and highlights the importance of different alternative sources of protein in preventing type 2 diabetes,” the researchers wrote.

Consumption and risk

The study included men and women who took part in the Nurses’ Health Study, the Nurses’ Health Study II, or the Health Professionals Follow-up Study. Questionnaires were used to collect data every 2-4 years on the frequency of specific food consumption. Information on the onset of diseases and on different health-related aspects was collected every 2 years.

Those who consumed more red meat had a higher body mass index, higher total energy intake, and greater likelihood of being a smoker. They were physically less active and less likely to take multivitamins. In a follow-up of 5.48 million person-years, 22,761 cases of type 2 diabetes were recorded.

The link between consumption of processed and unprocessed red meat (and both combined) and a higher risk of diabetes was observed in all cohorts when analyzed separately and jointly. The people in the highest quintile for combined red meat consumption had a 2% greater risk of developing the disease, compared with those in the lowest quintile. The risk increases associated with processed and unprocessed meat were 51% and 40%, respectively. One additional serving per day of processed red meat was associated with a 1.46-fold greater risk of diabetes. This risk was 1.24 times greater for unprocessed meat and 1.28 times greater for both types combined.

The associations had a linear dose-response relationship and remained firm even after accounting for BMI, which the researchers stressed could be a mediating factor. Finally, the associations were stronger when considering the average cumulative consumption over the 30-year follow-up period and still stronger following the calibration of meat consumption with data extrapolated from food registers. The latter step was taken to account for measurement errors.
 

Alternatives are better

By analyzing alternative protein sources, the researchers discovered that nuts and legumes are associated with the most substantial reductions in diabetes risk. “This discovery is consistent with the evidence that shows that sources of unsaturated fatty acids and antioxidants have beneficial effects on glycemic control, insulin response, and inflammation,” they wrote. By replacing a serving of processed red meat, unprocessed red meat, or a combination of the two with a serving of dry fruit or legumes, the risk of developing diabetes is lowered by 30%, 41%, and 29%, respectively. Replacing red meat with a serving of dairy products is also associated with a reduced risk.

Confirmation

Several biological mechanisms could contribute to the increased risk for type 2 diabetes in people who consume red meat. The high level of saturated fats or the relatively low level of polyunsaturated fats, heme iron, or the high nitrate content in processed red meats could play a role. A strong positive association between consumption of this meat, particularly when processed, and the onset of diabetes has already emerged from other studies, including a trial carried out several years ago in the same cohorts. “In the current study, we wanted to look at this association in the same three cohorts in more detail, with over 9,000 additional cases of type 2 diabetes documented with extensive follow-up,” the researchers explained.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Excess consumption of red meat, whether processed or not, is linked to a greater risk for developing type 2 diabetes. This association was confirmed by a new study published in the American Journal of Clinical Nutrition, a data analysis of nearly 217,000 people who were monitored for three decades as part of several cohort studies. “Our study supports the current dietary recommendations of limiting consumption of red meat and highlights the importance of different alternative sources of protein in preventing type 2 diabetes,” the researchers wrote.

Consumption and risk

The study included men and women who took part in the Nurses’ Health Study, the Nurses’ Health Study II, or the Health Professionals Follow-up Study. Questionnaires were used to collect data every 2-4 years on the frequency of specific food consumption. Information on the onset of diseases and on different health-related aspects was collected every 2 years.

Those who consumed more red meat had a higher body mass index, higher total energy intake, and greater likelihood of being a smoker. They were physically less active and less likely to take multivitamins. In a follow-up of 5.48 million person-years, 22,761 cases of type 2 diabetes were recorded.

The link between consumption of processed and unprocessed red meat (and both combined) and a higher risk of diabetes was observed in all cohorts when analyzed separately and jointly. The people in the highest quintile for combined red meat consumption had a 2% greater risk of developing the disease, compared with those in the lowest quintile. The risk increases associated with processed and unprocessed meat were 51% and 40%, respectively. One additional serving per day of processed red meat was associated with a 1.46-fold greater risk of diabetes. This risk was 1.24 times greater for unprocessed meat and 1.28 times greater for both types combined.

The associations had a linear dose-response relationship and remained firm even after accounting for BMI, which the researchers stressed could be a mediating factor. Finally, the associations were stronger when considering the average cumulative consumption over the 30-year follow-up period and still stronger following the calibration of meat consumption with data extrapolated from food registers. The latter step was taken to account for measurement errors.
 

Alternatives are better

By analyzing alternative protein sources, the researchers discovered that nuts and legumes are associated with the most substantial reductions in diabetes risk. “This discovery is consistent with the evidence that shows that sources of unsaturated fatty acids and antioxidants have beneficial effects on glycemic control, insulin response, and inflammation,” they wrote. By replacing a serving of processed red meat, unprocessed red meat, or a combination of the two with a serving of dry fruit or legumes, the risk of developing diabetes is lowered by 30%, 41%, and 29%, respectively. Replacing red meat with a serving of dairy products is also associated with a reduced risk.

Confirmation

Several biological mechanisms could contribute to the increased risk for type 2 diabetes in people who consume red meat. The high level of saturated fats or the relatively low level of polyunsaturated fats, heme iron, or the high nitrate content in processed red meats could play a role. A strong positive association between consumption of this meat, particularly when processed, and the onset of diabetes has already emerged from other studies, including a trial carried out several years ago in the same cohorts. “In the current study, we wanted to look at this association in the same three cohorts in more detail, with over 9,000 additional cases of type 2 diabetes documented with extensive follow-up,” the researchers explained.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Excess consumption of red meat, whether processed or not, is linked to a greater risk for developing type 2 diabetes. This association was confirmed by a new study published in the American Journal of Clinical Nutrition, a data analysis of nearly 217,000 people who were monitored for three decades as part of several cohort studies. “Our study supports the current dietary recommendations of limiting consumption of red meat and highlights the importance of different alternative sources of protein in preventing type 2 diabetes,” the researchers wrote.

Consumption and risk

The study included men and women who took part in the Nurses’ Health Study, the Nurses’ Health Study II, or the Health Professionals Follow-up Study. Questionnaires were used to collect data every 2-4 years on the frequency of specific food consumption. Information on the onset of diseases and on different health-related aspects was collected every 2 years.

Those who consumed more red meat had a higher body mass index, higher total energy intake, and greater likelihood of being a smoker. They were physically less active and less likely to take multivitamins. In a follow-up of 5.48 million person-years, 22,761 cases of type 2 diabetes were recorded.

The link between consumption of processed and unprocessed red meat (and both combined) and a higher risk of diabetes was observed in all cohorts when analyzed separately and jointly. The people in the highest quintile for combined red meat consumption had a 2% greater risk of developing the disease, compared with those in the lowest quintile. The risk increases associated with processed and unprocessed meat were 51% and 40%, respectively. One additional serving per day of processed red meat was associated with a 1.46-fold greater risk of diabetes. This risk was 1.24 times greater for unprocessed meat and 1.28 times greater for both types combined.

The associations had a linear dose-response relationship and remained firm even after accounting for BMI, which the researchers stressed could be a mediating factor. Finally, the associations were stronger when considering the average cumulative consumption over the 30-year follow-up period and still stronger following the calibration of meat consumption with data extrapolated from food registers. The latter step was taken to account for measurement errors.
 

Alternatives are better

By analyzing alternative protein sources, the researchers discovered that nuts and legumes are associated with the most substantial reductions in diabetes risk. “This discovery is consistent with the evidence that shows that sources of unsaturated fatty acids and antioxidants have beneficial effects on glycemic control, insulin response, and inflammation,” they wrote. By replacing a serving of processed red meat, unprocessed red meat, or a combination of the two with a serving of dry fruit or legumes, the risk of developing diabetes is lowered by 30%, 41%, and 29%, respectively. Replacing red meat with a serving of dairy products is also associated with a reduced risk.

Confirmation

Several biological mechanisms could contribute to the increased risk for type 2 diabetes in people who consume red meat. The high level of saturated fats or the relatively low level of polyunsaturated fats, heme iron, or the high nitrate content in processed red meats could play a role. A strong positive association between consumption of this meat, particularly when processed, and the onset of diabetes has already emerged from other studies, including a trial carried out several years ago in the same cohorts. “In the current study, we wanted to look at this association in the same three cohorts in more detail, with over 9,000 additional cases of type 2 diabetes documented with extensive follow-up,” the researchers explained.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

I cock my head at my “new” patient, Sherri, who heads into my consultation room at 8:30 on a rainy Monday morning. She looks vaguely familiar but I can’t quite place her face. “Dr. Messer,” she cries, “don’t you remember me? I was one of your very first patients 15 years ago in Westchester. You had just finished training.” Suddenly it all comes back to me.

Meeting Sherri reminded me of the lesson in humility that my mentor, Dr. Alice Levine, taught our crowded lecture hall so many years ago. Once upon a time, she prided herself on being an infinitely important doctor. One day, she met a patient with empty sella syndrome (literally missing his whole pituitary gland – MRI proven). She fully expected to swoop in to save the patient’s life by expertly replacing each absconded pituitary hormone, but to her shock and delight, an invisible little sliver of pituitary left in his brain allowed him to magically eek out completely normal hormone levels.

Sherri walked into my office so many years ago with a body mass index in the mid-40s. In laymen’s terms, she was morbidly obese. I settled in to discuss her hypertension, diabetes, high cholesterol, fatty liver, polycystic ovary syndrome, etc., but to my shock and delight, her blood pressure and blood work were completely normal. I struggled to keep a neutral face. She was there to discuss hair loss. I had just met my first patient with metabolically healthy obesity (MHO), and I was floored.

Fast-forward 15 years. Sherri sits down across the desk from me and hands me her blood work. Her formerly pristine labs are now peppered with red exclamation points and critically high lab values. Sherri had transitioned from MHO to metabolically unhealthy obesity (MUO).

Early clinical trials concluded that it was possible to have obesity but be metabolically healthy. Approximately 15% of patients living with obesity lack any of the comorbidities typically associated with this phenotype. These findings contributed to the de-emphasis on obesity as a true disease state.

In retrospect, the MHO subtype appears to be much more common in the younger and more active population and is typically quite transient. A new study published in Diabetes, Obesity and Metabolism revealed that people with MHO are 1.5 times more likely to develop diabetes vs. metabolically healthy normal-weight individuals. In addition, people living with obesity and no known metabolic complications still had a 50% higher risk for coronary artery disease. The study also showed that over 50% of people initially characterized as MHO eventually became MUO after a 16-year follow-up.

So once again, all roads lead to semaglutide (Wegovy), the most effective U.S. Food and Drug Administration–approved weight loss medication to date. The incretin class of medications not only helps patients lose 15% or more of their body weight, but it also helps reverse insulin resistance, lower the risk for heart disease, melt away fatty liver, and lower cholesterol levels and blood pressures. While an emphasis on lifestyle changes is always important, these medications are critical adjuncts to conventional therapies.

Sherri’s nearly inevitable transition from MHO to MUO speaks to the pressing need to treat patients living with obesity before the metabolic complications and increased cardiovascular risk develop. Fifteen years ago, I discussed her hair loss for 45 minutes and never mentioned the looming issue. Of course, back then there was no semaglutide or tirzepatide, which was just approved for obesity.

Sherri left our most recent visit with a prescription for Wegovy as well as appointments with a complimentary trainer and dietitian. Now that we have the tools we need, let’s commit to helping our patients achieve true metabolic health. Unlike the magical pituitary patient, metabolically healthy obesity is an illusion – and we owe it to our patients to treat it as such.

Dr. Messer is a clinical assistant professor at Mount Sinai School of Medicine, New York, and an associate professor at Hofstra University, Hempstead, N.Y. She disclosed no relevant conflicts of interest.

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

I cock my head at my “new” patient, Sherri, who heads into my consultation room at 8:30 on a rainy Monday morning. She looks vaguely familiar but I can’t quite place her face. “Dr. Messer,” she cries, “don’t you remember me? I was one of your very first patients 15 years ago in Westchester. You had just finished training.” Suddenly it all comes back to me.

Meeting Sherri reminded me of the lesson in humility that my mentor, Dr. Alice Levine, taught our crowded lecture hall so many years ago. Once upon a time, she prided herself on being an infinitely important doctor. One day, she met a patient with empty sella syndrome (literally missing his whole pituitary gland – MRI proven). She fully expected to swoop in to save the patient’s life by expertly replacing each absconded pituitary hormone, but to her shock and delight, an invisible little sliver of pituitary left in his brain allowed him to magically eek out completely normal hormone levels.

Sherri walked into my office so many years ago with a body mass index in the mid-40s. In laymen’s terms, she was morbidly obese. I settled in to discuss her hypertension, diabetes, high cholesterol, fatty liver, polycystic ovary syndrome, etc., but to my shock and delight, her blood pressure and blood work were completely normal. I struggled to keep a neutral face. She was there to discuss hair loss. I had just met my first patient with metabolically healthy obesity (MHO), and I was floored.

Fast-forward 15 years. Sherri sits down across the desk from me and hands me her blood work. Her formerly pristine labs are now peppered with red exclamation points and critically high lab values. Sherri had transitioned from MHO to metabolically unhealthy obesity (MUO).

Early clinical trials concluded that it was possible to have obesity but be metabolically healthy. Approximately 15% of patients living with obesity lack any of the comorbidities typically associated with this phenotype. These findings contributed to the de-emphasis on obesity as a true disease state.

In retrospect, the MHO subtype appears to be much more common in the younger and more active population and is typically quite transient. A new study published in Diabetes, Obesity and Metabolism revealed that people with MHO are 1.5 times more likely to develop diabetes vs. metabolically healthy normal-weight individuals. In addition, people living with obesity and no known metabolic complications still had a 50% higher risk for coronary artery disease. The study also showed that over 50% of people initially characterized as MHO eventually became MUO after a 16-year follow-up.

So once again, all roads lead to semaglutide (Wegovy), the most effective U.S. Food and Drug Administration–approved weight loss medication to date. The incretin class of medications not only helps patients lose 15% or more of their body weight, but it also helps reverse insulin resistance, lower the risk for heart disease, melt away fatty liver, and lower cholesterol levels and blood pressures. While an emphasis on lifestyle changes is always important, these medications are critical adjuncts to conventional therapies.

Sherri’s nearly inevitable transition from MHO to MUO speaks to the pressing need to treat patients living with obesity before the metabolic complications and increased cardiovascular risk develop. Fifteen years ago, I discussed her hair loss for 45 minutes and never mentioned the looming issue. Of course, back then there was no semaglutide or tirzepatide, which was just approved for obesity.

Sherri left our most recent visit with a prescription for Wegovy as well as appointments with a complimentary trainer and dietitian. Now that we have the tools we need, let’s commit to helping our patients achieve true metabolic health. Unlike the magical pituitary patient, metabolically healthy obesity is an illusion – and we owe it to our patients to treat it as such.

Dr. Messer is a clinical assistant professor at Mount Sinai School of Medicine, New York, and an associate professor at Hofstra University, Hempstead, N.Y. She disclosed no relevant conflicts of interest.

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

I cock my head at my “new” patient, Sherri, who heads into my consultation room at 8:30 on a rainy Monday morning. She looks vaguely familiar but I can’t quite place her face. “Dr. Messer,” she cries, “don’t you remember me? I was one of your very first patients 15 years ago in Westchester. You had just finished training.” Suddenly it all comes back to me.

Meeting Sherri reminded me of the lesson in humility that my mentor, Dr. Alice Levine, taught our crowded lecture hall so many years ago. Once upon a time, she prided herself on being an infinitely important doctor. One day, she met a patient with empty sella syndrome (literally missing his whole pituitary gland – MRI proven). She fully expected to swoop in to save the patient’s life by expertly replacing each absconded pituitary hormone, but to her shock and delight, an invisible little sliver of pituitary left in his brain allowed him to magically eek out completely normal hormone levels.

Sherri walked into my office so many years ago with a body mass index in the mid-40s. In laymen’s terms, she was morbidly obese. I settled in to discuss her hypertension, diabetes, high cholesterol, fatty liver, polycystic ovary syndrome, etc., but to my shock and delight, her blood pressure and blood work were completely normal. I struggled to keep a neutral face. She was there to discuss hair loss. I had just met my first patient with metabolically healthy obesity (MHO), and I was floored.

Fast-forward 15 years. Sherri sits down across the desk from me and hands me her blood work. Her formerly pristine labs are now peppered with red exclamation points and critically high lab values. Sherri had transitioned from MHO to metabolically unhealthy obesity (MUO).

Early clinical trials concluded that it was possible to have obesity but be metabolically healthy. Approximately 15% of patients living with obesity lack any of the comorbidities typically associated with this phenotype. These findings contributed to the de-emphasis on obesity as a true disease state.

In retrospect, the MHO subtype appears to be much more common in the younger and more active population and is typically quite transient. A new study published in Diabetes, Obesity and Metabolism revealed that people with MHO are 1.5 times more likely to develop diabetes vs. metabolically healthy normal-weight individuals. In addition, people living with obesity and no known metabolic complications still had a 50% higher risk for coronary artery disease. The study also showed that over 50% of people initially characterized as MHO eventually became MUO after a 16-year follow-up.

So once again, all roads lead to semaglutide (Wegovy), the most effective U.S. Food and Drug Administration–approved weight loss medication to date. The incretin class of medications not only helps patients lose 15% or more of their body weight, but it also helps reverse insulin resistance, lower the risk for heart disease, melt away fatty liver, and lower cholesterol levels and blood pressures. While an emphasis on lifestyle changes is always important, these medications are critical adjuncts to conventional therapies.

Sherri’s nearly inevitable transition from MHO to MUO speaks to the pressing need to treat patients living with obesity before the metabolic complications and increased cardiovascular risk develop. Fifteen years ago, I discussed her hair loss for 45 minutes and never mentioned the looming issue. Of course, back then there was no semaglutide or tirzepatide, which was just approved for obesity.

Sherri left our most recent visit with a prescription for Wegovy as well as appointments with a complimentary trainer and dietitian. Now that we have the tools we need, let’s commit to helping our patients achieve true metabolic health. Unlike the magical pituitary patient, metabolically healthy obesity is an illusion – and we owe it to our patients to treat it as such.

Dr. Messer is a clinical assistant professor at Mount Sinai School of Medicine, New York, and an associate professor at Hofstra University, Hempstead, N.Y. She disclosed no relevant conflicts of interest.

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