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Results from halted islatravir antiretroviral trial presented
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
PRISm and nonspecific pattern: New insights in lung testing interpretation
The recent statement on interpretive strategies for lung testing uses the acronym PRISm for preserved ratio impaired spirometry. PRISm identifies patients with a normal forced expiratory volume in 1 second/forced vital capacity ratio but abnormal FEV1 and/or FVC (usually both). Most medical students are taught to call this a “restrictive pattern,” and every first-year pulmonary fellow orders full lung volumes when they see it. If total lung capacity (TLC) is normal, PRISm becomes the nonspecific pattern. If TLC is low, then the patient has “true” restriction, and if it’s elevated, then hyperinflation may be present.
The traditional classification scheme for basic spirometry interpretation (normal, restricted, obstructed, or mixed) is simple and conceptually clear. It turns out that many with this pattern won’t have an abnormal TLC, so the name is, in some ways, a misnomer and can be misleading. Enter PRISm, a more descriptive and inclusive term. The phrase also lends itself to a phonetic acronym that is fun to say, easy to remember, and likely to catch on with learners.
Information on occurrence and clinical behavior comes from large cohorts with basic spirometry, but without full lung volumes because PRISm no longer applies once TLC is determined. As may be expected, prevalence varies by the population studied. Estimates for general populations have been in the 7%-12% range; however, one study examining a database of patients with clinical spirometry referrals found a prevalence of 22.3%. Rates may be far higher in low- and middle-income countries. Identified risk factors include sex, tobacco use, and body mass index; the presence of PRISm is associated with respiratory symptoms and mortality. Thus, PRISm is common and it matters.
Along with PRISm, the nonspecific pattern is a new addition, if not a new concept, to the 2022 interpretative strategies statement. As with PRISm, the title is necessarily broad, though far less imaginative. Defined by reductions in FEV1 and FVC and a normal TLC, the nonspecific pattern has classically been considered a marker of early airway disease. The idea is that early, heterogeneous closure of distal segments of the bronchial tree can reduce total volume during a forced expiration before affecting the FEV1/FVC. The fact that the TLC is not a forced maneuver means there is proportionately less effect from more collapsible/susceptible smaller units. More recent data suggest that there are additional causes.
Because the nonspecific pattern requires full lung volumes, we have less population-level data than for PRISm. Estimated prevalence is approximately 9.5% in patients with complete test results. The two most common causes are obesity and airway obstruction, and the pattern is relatively stable over time. Notably, an increase in specific airway resistance or TLC minus alveolar volume difference predicts progression to frank obstruction on spirometry.
The physiologic changes that obesity inflicts on the lung have been well described. Patients with obesity breathe at lower lung volumes and are therefore susceptible to small airway closure at rest and during forced expiration. There is no doubt that the increased recognition of PRISm and the nonspecific pattern is in part related to the worldwide rise in obesity rates.
Key takeaways
In summary, PRISm and the nonspecific pattern are now part of the classification scheme we use for spirometry and full lung volumes, respectively. They should be included in interpretations given their diagnostic and predictive value. Airway disease and obesity are common causes and often coexist with either pattern. Many will not have a true, restrictive lung deficit, and a reductionist approach to interpretation is likely to lead to erroneous diagnoses. There were many important updates included in the 2022 iteration on lung testing interpretation that should not fly under the radar.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He disclosed ties with CHEST College, Metapharm, and WebMD.
A version of this article appeared on Medscape.com.
The recent statement on interpretive strategies for lung testing uses the acronym PRISm for preserved ratio impaired spirometry. PRISm identifies patients with a normal forced expiratory volume in 1 second/forced vital capacity ratio but abnormal FEV1 and/or FVC (usually both). Most medical students are taught to call this a “restrictive pattern,” and every first-year pulmonary fellow orders full lung volumes when they see it. If total lung capacity (TLC) is normal, PRISm becomes the nonspecific pattern. If TLC is low, then the patient has “true” restriction, and if it’s elevated, then hyperinflation may be present.
The traditional classification scheme for basic spirometry interpretation (normal, restricted, obstructed, or mixed) is simple and conceptually clear. It turns out that many with this pattern won’t have an abnormal TLC, so the name is, in some ways, a misnomer and can be misleading. Enter PRISm, a more descriptive and inclusive term. The phrase also lends itself to a phonetic acronym that is fun to say, easy to remember, and likely to catch on with learners.
Information on occurrence and clinical behavior comes from large cohorts with basic spirometry, but without full lung volumes because PRISm no longer applies once TLC is determined. As may be expected, prevalence varies by the population studied. Estimates for general populations have been in the 7%-12% range; however, one study examining a database of patients with clinical spirometry referrals found a prevalence of 22.3%. Rates may be far higher in low- and middle-income countries. Identified risk factors include sex, tobacco use, and body mass index; the presence of PRISm is associated with respiratory symptoms and mortality. Thus, PRISm is common and it matters.
Along with PRISm, the nonspecific pattern is a new addition, if not a new concept, to the 2022 interpretative strategies statement. As with PRISm, the title is necessarily broad, though far less imaginative. Defined by reductions in FEV1 and FVC and a normal TLC, the nonspecific pattern has classically been considered a marker of early airway disease. The idea is that early, heterogeneous closure of distal segments of the bronchial tree can reduce total volume during a forced expiration before affecting the FEV1/FVC. The fact that the TLC is not a forced maneuver means there is proportionately less effect from more collapsible/susceptible smaller units. More recent data suggest that there are additional causes.
Because the nonspecific pattern requires full lung volumes, we have less population-level data than for PRISm. Estimated prevalence is approximately 9.5% in patients with complete test results. The two most common causes are obesity and airway obstruction, and the pattern is relatively stable over time. Notably, an increase in specific airway resistance or TLC minus alveolar volume difference predicts progression to frank obstruction on spirometry.
The physiologic changes that obesity inflicts on the lung have been well described. Patients with obesity breathe at lower lung volumes and are therefore susceptible to small airway closure at rest and during forced expiration. There is no doubt that the increased recognition of PRISm and the nonspecific pattern is in part related to the worldwide rise in obesity rates.
Key takeaways
In summary, PRISm and the nonspecific pattern are now part of the classification scheme we use for spirometry and full lung volumes, respectively. They should be included in interpretations given their diagnostic and predictive value. Airway disease and obesity are common causes and often coexist with either pattern. Many will not have a true, restrictive lung deficit, and a reductionist approach to interpretation is likely to lead to erroneous diagnoses. There were many important updates included in the 2022 iteration on lung testing interpretation that should not fly under the radar.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He disclosed ties with CHEST College, Metapharm, and WebMD.
A version of this article appeared on Medscape.com.
The recent statement on interpretive strategies for lung testing uses the acronym PRISm for preserved ratio impaired spirometry. PRISm identifies patients with a normal forced expiratory volume in 1 second/forced vital capacity ratio but abnormal FEV1 and/or FVC (usually both). Most medical students are taught to call this a “restrictive pattern,” and every first-year pulmonary fellow orders full lung volumes when they see it. If total lung capacity (TLC) is normal, PRISm becomes the nonspecific pattern. If TLC is low, then the patient has “true” restriction, and if it’s elevated, then hyperinflation may be present.
The traditional classification scheme for basic spirometry interpretation (normal, restricted, obstructed, or mixed) is simple and conceptually clear. It turns out that many with this pattern won’t have an abnormal TLC, so the name is, in some ways, a misnomer and can be misleading. Enter PRISm, a more descriptive and inclusive term. The phrase also lends itself to a phonetic acronym that is fun to say, easy to remember, and likely to catch on with learners.
Information on occurrence and clinical behavior comes from large cohorts with basic spirometry, but without full lung volumes because PRISm no longer applies once TLC is determined. As may be expected, prevalence varies by the population studied. Estimates for general populations have been in the 7%-12% range; however, one study examining a database of patients with clinical spirometry referrals found a prevalence of 22.3%. Rates may be far higher in low- and middle-income countries. Identified risk factors include sex, tobacco use, and body mass index; the presence of PRISm is associated with respiratory symptoms and mortality. Thus, PRISm is common and it matters.
Along with PRISm, the nonspecific pattern is a new addition, if not a new concept, to the 2022 interpretative strategies statement. As with PRISm, the title is necessarily broad, though far less imaginative. Defined by reductions in FEV1 and FVC and a normal TLC, the nonspecific pattern has classically been considered a marker of early airway disease. The idea is that early, heterogeneous closure of distal segments of the bronchial tree can reduce total volume during a forced expiration before affecting the FEV1/FVC. The fact that the TLC is not a forced maneuver means there is proportionately less effect from more collapsible/susceptible smaller units. More recent data suggest that there are additional causes.
Because the nonspecific pattern requires full lung volumes, we have less population-level data than for PRISm. Estimated prevalence is approximately 9.5% in patients with complete test results. The two most common causes are obesity and airway obstruction, and the pattern is relatively stable over time. Notably, an increase in specific airway resistance or TLC minus alveolar volume difference predicts progression to frank obstruction on spirometry.
The physiologic changes that obesity inflicts on the lung have been well described. Patients with obesity breathe at lower lung volumes and are therefore susceptible to small airway closure at rest and during forced expiration. There is no doubt that the increased recognition of PRISm and the nonspecific pattern is in part related to the worldwide rise in obesity rates.
Key takeaways
In summary, PRISm and the nonspecific pattern are now part of the classification scheme we use for spirometry and full lung volumes, respectively. They should be included in interpretations given their diagnostic and predictive value. Airway disease and obesity are common causes and often coexist with either pattern. Many will not have a true, restrictive lung deficit, and a reductionist approach to interpretation is likely to lead to erroneous diagnoses. There were many important updates included in the 2022 iteration on lung testing interpretation that should not fly under the radar.
Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He disclosed ties with CHEST College, Metapharm, and WebMD.
A version of this article appeared on Medscape.com.
New AHA/ACC performance, quality metrics for coronary revascularization
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Obesity cardiomyopathy tied to sudden cardiac death
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JACC: ADVANCES
LAAO tied to fewer post-fall bleeds than DOACs in AF
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Studies link GLP-1 agonists to progression of diabetic retinopathy
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM ASRS 2023
Clinicians debate the usefulness of NAFLD name change
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Time-restricted eating gains for weight and glycemic control
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
FROM ADA 2023
Disclosure inaccuracies common in top rheumatology journals
TOPLINE:
Conflicts of interests in rheumatology research – particularly for clinical trials – are often incorrectly reported, according to a new analysis.
METHODOLOGY:
- Researchers reviewed the first 50 clinical research reports, reviews, and editorials published in 2019 by Arthritis & Rheumatology, Arthritis Care & Research, and Seminars in Arthritis & Rheumatism.
- They cross-checked disclosures from the first, second, and last authors of each paper (150 total) with payment reports from the Open Payments Database (OPD).
- Payment reports captured consulting fees, honoraria, and speaker/faculty compensation in the 36 months prior to an article’s publication.
TAKEAWAY:
- A total of 87% of the 135 authors with potential conflicts of interest (PCOI) inaccurately reported their disclosures.
- All authors of the included 14 clinical trial publications either did not report or underreported PCOI.
- The total nondisclosed dollar amount was $5,190,901, and the total underdisclosed amount was $4,135,126.
IN PRACTICE:
“Improved community education and firmer expectations would permit readers to better assess any possible impact of PCOI on publications,” the authors wrote.
STUDY DETAILS:
Mary Guan, MD, of the NYU Grossman School of Medicine, New York, led the research. The study was published online in Arthritis Care & Research on July 31, 2023.
LIMITATIONS:
The OPD does not include non–U.S.-based authors and authors without a medical degree, and there are no data on the accuracy of the database. The analysis does not provide insight into why these discrepancies occurred and if they were unintentional errors.
DISCLOSURES:
One coauthor reported consulting fees from Federation Bio, Fortress Biotech, Horizon, and Sobi and receiving grants or contracts paid to his institution from Horizon and Hikma. Dr. Guan and senior author Aryeh Abeles, MD, reported no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Conflicts of interests in rheumatology research – particularly for clinical trials – are often incorrectly reported, according to a new analysis.
METHODOLOGY:
- Researchers reviewed the first 50 clinical research reports, reviews, and editorials published in 2019 by Arthritis & Rheumatology, Arthritis Care & Research, and Seminars in Arthritis & Rheumatism.
- They cross-checked disclosures from the first, second, and last authors of each paper (150 total) with payment reports from the Open Payments Database (OPD).
- Payment reports captured consulting fees, honoraria, and speaker/faculty compensation in the 36 months prior to an article’s publication.
TAKEAWAY:
- A total of 87% of the 135 authors with potential conflicts of interest (PCOI) inaccurately reported their disclosures.
- All authors of the included 14 clinical trial publications either did not report or underreported PCOI.
- The total nondisclosed dollar amount was $5,190,901, and the total underdisclosed amount was $4,135,126.
IN PRACTICE:
“Improved community education and firmer expectations would permit readers to better assess any possible impact of PCOI on publications,” the authors wrote.
STUDY DETAILS:
Mary Guan, MD, of the NYU Grossman School of Medicine, New York, led the research. The study was published online in Arthritis Care & Research on July 31, 2023.
LIMITATIONS:
The OPD does not include non–U.S.-based authors and authors without a medical degree, and there are no data on the accuracy of the database. The analysis does not provide insight into why these discrepancies occurred and if they were unintentional errors.
DISCLOSURES:
One coauthor reported consulting fees from Federation Bio, Fortress Biotech, Horizon, and Sobi and receiving grants or contracts paid to his institution from Horizon and Hikma. Dr. Guan and senior author Aryeh Abeles, MD, reported no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Conflicts of interests in rheumatology research – particularly for clinical trials – are often incorrectly reported, according to a new analysis.
METHODOLOGY:
- Researchers reviewed the first 50 clinical research reports, reviews, and editorials published in 2019 by Arthritis & Rheumatology, Arthritis Care & Research, and Seminars in Arthritis & Rheumatism.
- They cross-checked disclosures from the first, second, and last authors of each paper (150 total) with payment reports from the Open Payments Database (OPD).
- Payment reports captured consulting fees, honoraria, and speaker/faculty compensation in the 36 months prior to an article’s publication.
TAKEAWAY:
- A total of 87% of the 135 authors with potential conflicts of interest (PCOI) inaccurately reported their disclosures.
- All authors of the included 14 clinical trial publications either did not report or underreported PCOI.
- The total nondisclosed dollar amount was $5,190,901, and the total underdisclosed amount was $4,135,126.
IN PRACTICE:
“Improved community education and firmer expectations would permit readers to better assess any possible impact of PCOI on publications,” the authors wrote.
STUDY DETAILS:
Mary Guan, MD, of the NYU Grossman School of Medicine, New York, led the research. The study was published online in Arthritis Care & Research on July 31, 2023.
LIMITATIONS:
The OPD does not include non–U.S.-based authors and authors without a medical degree, and there are no data on the accuracy of the database. The analysis does not provide insight into why these discrepancies occurred and if they were unintentional errors.
DISCLOSURES:
One coauthor reported consulting fees from Federation Bio, Fortress Biotech, Horizon, and Sobi and receiving grants or contracts paid to his institution from Horizon and Hikma. Dr. Guan and senior author Aryeh Abeles, MD, reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ARTHRITIS CARE & RESEARCH
Autoantibodies could help predict cancer risk in scleroderma
TOPLINE:
METHODOLOGY:
- Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
- A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
- Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
- Examined association between autoantibodies and overall cancer risk.
TAKEAWAYS:
- Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
- Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
- These associations remained when looking specifically at cancer-associated scleroderma.
- Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.
IN PRACTICE:
This study is too preliminary to have practice application.
SOURCE:
Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.
DISCLOSURES:
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
- A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
- Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
- Examined association between autoantibodies and overall cancer risk.
TAKEAWAYS:
- Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
- Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
- These associations remained when looking specifically at cancer-associated scleroderma.
- Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.
IN PRACTICE:
This study is too preliminary to have practice application.
SOURCE:
Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.
DISCLOSURES:
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
- A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
- Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
- Examined association between autoantibodies and overall cancer risk.
TAKEAWAYS:
- Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
- Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
- These associations remained when looking specifically at cancer-associated scleroderma.
- Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.
IN PRACTICE:
This study is too preliminary to have practice application.
SOURCE:
Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.
DISCLOSURES:
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.
A version of this article appeared on Medscape.com.
FROM ARTHRITIS & RHEUMATOLOGY