Pub Date : 2026-02-04DOI: 10.1001/jamacardio.2025.5240
Gregg C Fonarow, Ann Marie Navar, Clyde W Yancy
{"title":"The Cost-Effectiveness Evolution of Cardiovascular Care.","authors":"Gregg C Fonarow, Ann Marie Navar, Clyde W Yancy","doi":"10.1001/jamacardio.2025.5240","DOIUrl":"https://doi.org/10.1001/jamacardio.2025.5240","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.1,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146118747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-04DOI: 10.1001/jamacardio.2025.5418
Samer Al Said, Siddharth M. Patel, Robert P. Giugliano, David A. Morrow, Erica L. Goodrich, Sabina A. Murphy, Bruce Hug, Sanobar Parkar, Shih-Ann Chen, Shaun G. Goodman, Boyoung Joung, Robert G. Kiss, Wojciech Wojakowski, Jeffrey I. Weitz, Dan Bloomfield, Marc S. Sabatine, Christian T. Ruff
Importance Older age is a strong risk factor for bleeding with currently available anticoagulants. Factor XI (FXI) inhibition may offer a safer anticoagulant strategy in this population. Objective To evaluate the safety of the novel FXI inhibitor abelacimab vs rivaroxaban by age in patients with atrial fibrillation (AF). Design, Setting, and Participants The randomized clinical trial AZALEA-TIMI 71 randomized patients with AF to receive 1 of 2 subcutaneous abelacimab doses (90 mg or 150 mg monthly) or oral rivaroxaban (20 mg daily, dose reduction to 15 mg). This prespecified analysis of the phase 2b AZALEA-TIMI 71 trial evaluated bleeding risk by age, analyzed continuously and categorically (&lt;75 vs ≥75 years). The trial was conducted from March 2021 to September 2023; data analysis was performed from February to May 2025. Interventions Monthly subcutaneous abelacimab (90 or 150 mg) or daily oral rivaroxaban (20/15 mg). Main Outcomes and Measures The primary end point was the composite of major or clinically relevant nonmajor (CRNM) bleeding. Results Among 1287 patients randomized, 715 (55.6%) were male and 572 (44.4%) were female; there were 625 patients (49%) 75 years or older. Compared with younger patients, those 75 years or older had lower body mass index (28 vs 32), were less likely to be taking antiplatelet therapy at baseline (17% vs 32%), and were more likely to have creatinine clearance 50 mL/min or less (33% vs 8%). Both abelacimab doses were associated with significantly less major or CRNM bleeding compared with rivaroxaban in those 75 years or older (hazard ratio [HR], 0.32; 95% CI, 0.17-0.60; and HR, 0.40; 95% CI, 0.22-0.73; for abelacimab, 90 and 150 mg, vs rivaroxaban, respectively) and in those younger than 75 years (HR, 0.28; 95% CI, 0.12-0.61; and HR, 0.35; 95% CI, 0.17-0.70; <jats:italic>P</jats:italic> for interaction, .85 and .84, respectively). Patients 75 years or older tended to derive greater absolute risk reductions with abelacimab (7.1 and 6.2 per 100 patient-years for abelacimab, 90 and 150 mg, vs rivaroxaban, respectively) than those younger than 75 years (4.7 and 4.2 per 100 patient-years, respectively). When modeled continuously, bleeding risk tended to increase with age in the rivaroxaban group but remained stable in the abelacimab group ( <jats:italic>P</jats:italic> for interaction, .33). Conclusions and Relevance This study found that abelacimab consistently reduced bleeding compared with rivaroxaban regardless of age, with the potential for a greater absolute reduction in bleeding with older age. FXI inhibition with abelacimab may become a particularly attractive option in older patients with AF and higher bleeding risk. The results of ongoing phase 3 trials are necessary to establish the efficacy and benefit-to-risk ratio of abelacimab. Trial Registration ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.go
{"title":"Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation","authors":"Samer Al Said, Siddharth M. Patel, Robert P. Giugliano, David A. Morrow, Erica L. Goodrich, Sabina A. Murphy, Bruce Hug, Sanobar Parkar, Shih-Ann Chen, Shaun G. Goodman, Boyoung Joung, Robert G. Kiss, Wojciech Wojakowski, Jeffrey I. Weitz, Dan Bloomfield, Marc S. Sabatine, Christian T. Ruff","doi":"10.1001/jamacardio.2025.5418","DOIUrl":"https://doi.org/10.1001/jamacardio.2025.5418","url":null,"abstract":"Importance Older age is a strong risk factor for bleeding with currently available anticoagulants. Factor XI (FXI) inhibition may offer a safer anticoagulant strategy in this population. Objective To evaluate the safety of the novel FXI inhibitor abelacimab vs rivaroxaban by age in patients with atrial fibrillation (AF). Design, Setting, and Participants The randomized clinical trial AZALEA-TIMI 71 randomized patients with AF to receive 1 of 2 subcutaneous abelacimab doses (90 mg or 150 mg monthly) or oral rivaroxaban (20 mg daily, dose reduction to 15 mg). This prespecified analysis of the phase 2b AZALEA-TIMI 71 trial evaluated bleeding risk by age, analyzed continuously and categorically (&amp;lt;75 vs ≥75 years). The trial was conducted from March 2021 to September 2023; data analysis was performed from February to May 2025. Interventions Monthly subcutaneous abelacimab (90 or 150 mg) or daily oral rivaroxaban (20/15 mg). Main Outcomes and Measures The primary end point was the composite of major or clinically relevant nonmajor (CRNM) bleeding. Results Among 1287 patients randomized, 715 (55.6%) were male and 572 (44.4%) were female; there were 625 patients (49%) 75 years or older. Compared with younger patients, those 75 years or older had lower body mass index (28 vs 32), were less likely to be taking antiplatelet therapy at baseline (17% vs 32%), and were more likely to have creatinine clearance 50 mL/min or less (33% vs 8%). Both abelacimab doses were associated with significantly less major or CRNM bleeding compared with rivaroxaban in those 75 years or older (hazard ratio [HR], 0.32; 95% CI, 0.17-0.60; and HR, 0.40; 95% CI, 0.22-0.73; for abelacimab, 90 and 150 mg, vs rivaroxaban, respectively) and in those younger than 75 years (HR, 0.28; 95% CI, 0.12-0.61; and HR, 0.35; 95% CI, 0.17-0.70; <jats:italic>P</jats:italic> for interaction, .85 and .84, respectively). Patients 75 years or older tended to derive greater absolute risk reductions with abelacimab (7.1 and 6.2 per 100 patient-years for abelacimab, 90 and 150 mg, vs rivaroxaban, respectively) than those younger than 75 years (4.7 and 4.2 per 100 patient-years, respectively). When modeled continuously, bleeding risk tended to increase with age in the rivaroxaban group but remained stable in the abelacimab group ( <jats:italic>P</jats:italic> for interaction, .33). Conclusions and Relevance This study found that abelacimab consistently reduced bleeding compared with rivaroxaban regardless of age, with the potential for a greater absolute reduction in bleeding with older age. FXI inhibition with abelacimab may become a particularly attractive option in older patients with AF and higher bleeding risk. The results of ongoing phase 3 trials are necessary to establish the efficacy and benefit-to-risk ratio of abelacimab. Trial Registration ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.go","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"1 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146115810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-04DOI: 10.1001/jamacardio.2025.5243
Susan Hennessy, Joanne Penko, Brandon K. Bellows, Pamela G. Coxson, Ross Boylan, Kendra D. Sims, Alexis Beatty, Kosuke Inoue, Ivy Shi, Sérgio R. R. Decker, Sadiya S. Khan, Robert W. Yeh, Andrew E. Moran, Dhruv S. Kazi
Importance Semaglutide reduces the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and cardiovascular disease (CVD) but without diabetes. The cost-effectiveness and budget impact of semaglutide therapy could inform ongoing Medicare price negotiations but are uncertain. Objective To evaluate the cost-effectiveness of semaglutide for secondary prevention of CVD and potential effect on US health care spending. Design, Setting, and Participants This population-based cohort simulation study used the CVD Policy Model, a validated simulation model of CVD outcomes and costs in the US, to evaluate lifetime cost-effectiveness of semaglutide. The addition of lifetime treatment with weekly subcutaneous semaglutide to usual care compared with usual care alone in US adults age 45 years or older, with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or higher, and history of myocardial infarction or stroke, without diabetes were evaluated. The model incorporated annual semaglutide cost of $8604 (2023 US price net of rebates and discounts) and adopted a health-system perspective. Sensitivity analyses explored uncertainty. These data were analyzed from January 2024 and June 2025. Exposure Semaglutide and usual care compared with usual care alone. Main Outcomes and Measures Main outcomes were lifetime MACE (cardiovascular death, myocardial infarction, or stroke), incremental cost per quality-adjusted life-year (QALY), and change in annual US health care spending. Results Adding semaglutide to usual care in the estimated 4 million US adults without diabetes eligible for secondary prevention of CVD is projected to avert 358 400 MACE at a cost of $148 100 per QALY gained (95% uncertainty interval, $127 100-$173 400). The mean age of this cohort was 66 years and 55% were male and 45% were female. Treatment with semaglutide was projected to increase annual health care spending by $23 billion. Semaglutide would be cost-effective at a threshold of $120 000 per QALY gained if the annual cost were lowered an additional 18% to $7055. Semaglutide is cost-effective for this indication at the cash price currently available to self-paying customers ($5988; incremental cost-effectiveness ratio, $99 600 per QALY gained). Conclusions and Relevance Semaglutide for secondary prevention of CVD in US adults with overweight or obesity but without diabetes is projected to yield meaningful health benefits. Lowering annual drug costs by 18% from $8604 to $7055—or making the current cash price available to all patients—would make semaglutide cost-effective at $120 000 per QALY gained.
{"title":"Cost-Effectiveness of Semaglutide for Secondary Prevention of Cardiovascular Disease in US Adults","authors":"Susan Hennessy, Joanne Penko, Brandon K. Bellows, Pamela G. Coxson, Ross Boylan, Kendra D. Sims, Alexis Beatty, Kosuke Inoue, Ivy Shi, Sérgio R. R. Decker, Sadiya S. Khan, Robert W. Yeh, Andrew E. Moran, Dhruv S. Kazi","doi":"10.1001/jamacardio.2025.5243","DOIUrl":"https://doi.org/10.1001/jamacardio.2025.5243","url":null,"abstract":"Importance Semaglutide reduces the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and cardiovascular disease (CVD) but without diabetes. The cost-effectiveness and budget impact of semaglutide therapy could inform ongoing Medicare price negotiations but are uncertain. Objective To evaluate the cost-effectiveness of semaglutide for secondary prevention of CVD and potential effect on US health care spending. Design, Setting, and Participants This population-based cohort simulation study used the CVD Policy Model, a validated simulation model of CVD outcomes and costs in the US, to evaluate lifetime cost-effectiveness of semaglutide. The addition of lifetime treatment with weekly subcutaneous semaglutide to usual care compared with usual care alone in US adults age 45 years or older, with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or higher, and history of myocardial infarction or stroke, without diabetes were evaluated. The model incorporated annual semaglutide cost of $8604 (2023 US price net of rebates and discounts) and adopted a health-system perspective. Sensitivity analyses explored uncertainty. These data were analyzed from January 2024 and June 2025. Exposure Semaglutide and usual care compared with usual care alone. Main Outcomes and Measures Main outcomes were lifetime MACE (cardiovascular death, myocardial infarction, or stroke), incremental cost per quality-adjusted life-year (QALY), and change in annual US health care spending. Results Adding semaglutide to usual care in the estimated 4 million US adults without diabetes eligible for secondary prevention of CVD is projected to avert 358 400 MACE at a cost of $148 100 per QALY gained (95% uncertainty interval, $127 100-$173 400). The mean age of this cohort was 66 years and 55% were male and 45% were female. Treatment with semaglutide was projected to increase annual health care spending by $23 billion. Semaglutide would be cost-effective at a threshold of $120 000 per QALY gained if the annual cost were lowered an additional 18% to $7055. Semaglutide is cost-effective for this indication at the cash price currently available to self-paying customers ($5988; incremental cost-effectiveness ratio, $99 600 per QALY gained). Conclusions and Relevance Semaglutide for secondary prevention of CVD in US adults with overweight or obesity but without diabetes is projected to yield meaningful health benefits. Lowering annual drug costs by 18% from $8604 to $7055—or making the current cash price available to all patients—would make semaglutide cost-effective at $120 000 per QALY gained.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"11 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146115809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-30DOI: 10.1001/jamacardio.2026.0119
Robert O Bonow
{"title":"The First Decade of JAMA Cardiology.","authors":"Robert O Bonow","doi":"10.1001/jamacardio.2026.0119","DOIUrl":"https://doi.org/10.1001/jamacardio.2026.0119","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"82 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146073209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-28DOI: 10.1001/jamacardio.2025.5339
Stephen J Greene,Haolin Xu,Karen Chiswell,G Michael Felker,Sabra C Lewsey,Punag H Divanji,Hans-Peter Goertz,Stephen B Heitner,Sanatan Shreay,Ambarish Pandey,Clyde W Yancy,Javed Butler,Gregg C Fonarow
ImportanceAmong patients with heart failure with reduced ejection fraction (HFrEF) in US clinical practice, the residual risk of poor clinical outcomes despite quadruple medical therapy is not well characterized.ObjectiveTo evaluate clinical outcomes and health care costs among patients hospitalized for HFrEF prescribed quadruple medical therapy at discharge.Design, Setting, and ParticipantsThis retrospective cohort study examined Medicare beneficiaries hospitalized for HFrEF in the Get With The Guidelines-Heart Failure registry and discharged from US hospitals receiving any dose of quadruple medical therapy (angiotensin receptor-neprilysin inhibitor, β-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor) between July 1, 2021, and December 31, 2023. Data analysis was conducted from October 2024 through March 2025.ExposurePrescription of quadruple medical therapy (angiotensin receptor-neprilysin inhibitor, β-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor) at time of hospital discharge.Main Outcomes and MeasuresThe primary outcomes were mortality, HF hospitalization, mortality or HF hospitalization, and per-patient health care expenditure (Medicare Part A and B inpatient and outpatient costs, in 2023 US dollars).ResultsAmong 20 651 patients with HFrEF eligible for quadruple medical therapy across 532 US hospitals, 1490 (7.2%) were prescribed quadruple therapy at discharge, with high between-hospital variance (median odds ratio, 2.04; 95% CI, 1.89-2.24). Median (IQR) age of patients prescribed quadruple therapy was 74 (69-81) years, and 543 patients (36.4%) were women. Over 12-month follow-up, cumulative incidences of all-cause mortality, HF hospitalization, and all-cause mortality or HF hospitalization were 19.3% (95% CI, 17.3%-21.4%), 26.0% (95% CI, 23.6%-28.5%), and 37.1% (95% CI, 34.4%-39.8%), respectively. Median (IQR) 12-month per-patient health care expenditure was $27 956 ($7478-$61 126). Twelve-month mortality and HF hospitalization outcomes were similar for patients prescribed quadruple medical therapy at discharge in the first half vs the second half of the study period.Conclusions and RelevanceIn this nationwide cohort study, even when prescribed quadruple medical therapy, older patients hospitalized for HFrEF in US clinical practice face substantial residual risk of death and HF readmission and often accrue high health care costs.
{"title":"One-Year Outcomes in Patients Hospitalized for Heart Failure With Reduced Ejection Fraction Prescribed Quadruple Medical Therapy at Discharge.","authors":"Stephen J Greene,Haolin Xu,Karen Chiswell,G Michael Felker,Sabra C Lewsey,Punag H Divanji,Hans-Peter Goertz,Stephen B Heitner,Sanatan Shreay,Ambarish Pandey,Clyde W Yancy,Javed Butler,Gregg C Fonarow","doi":"10.1001/jamacardio.2025.5339","DOIUrl":"https://doi.org/10.1001/jamacardio.2025.5339","url":null,"abstract":"ImportanceAmong patients with heart failure with reduced ejection fraction (HFrEF) in US clinical practice, the residual risk of poor clinical outcomes despite quadruple medical therapy is not well characterized.ObjectiveTo evaluate clinical outcomes and health care costs among patients hospitalized for HFrEF prescribed quadruple medical therapy at discharge.Design, Setting, and ParticipantsThis retrospective cohort study examined Medicare beneficiaries hospitalized for HFrEF in the Get With The Guidelines-Heart Failure registry and discharged from US hospitals receiving any dose of quadruple medical therapy (angiotensin receptor-neprilysin inhibitor, β-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor) between July 1, 2021, and December 31, 2023. Data analysis was conducted from October 2024 through March 2025.ExposurePrescription of quadruple medical therapy (angiotensin receptor-neprilysin inhibitor, β-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor) at time of hospital discharge.Main Outcomes and MeasuresThe primary outcomes were mortality, HF hospitalization, mortality or HF hospitalization, and per-patient health care expenditure (Medicare Part A and B inpatient and outpatient costs, in 2023 US dollars).ResultsAmong 20 651 patients with HFrEF eligible for quadruple medical therapy across 532 US hospitals, 1490 (7.2%) were prescribed quadruple therapy at discharge, with high between-hospital variance (median odds ratio, 2.04; 95% CI, 1.89-2.24). Median (IQR) age of patients prescribed quadruple therapy was 74 (69-81) years, and 543 patients (36.4%) were women. Over 12-month follow-up, cumulative incidences of all-cause mortality, HF hospitalization, and all-cause mortality or HF hospitalization were 19.3% (95% CI, 17.3%-21.4%), 26.0% (95% CI, 23.6%-28.5%), and 37.1% (95% CI, 34.4%-39.8%), respectively. Median (IQR) 12-month per-patient health care expenditure was $27 956 ($7478-$61 126). Twelve-month mortality and HF hospitalization outcomes were similar for patients prescribed quadruple medical therapy at discharge in the first half vs the second half of the study period.Conclusions and RelevanceIn this nationwide cohort study, even when prescribed quadruple medical therapy, older patients hospitalized for HFrEF in US clinical practice face substantial residual risk of death and HF readmission and often accrue high health care costs.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"74 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146056843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-28DOI: 10.1001/jamacardio.2025.5305
Louisa A Mounsey,Mandana Chitsazan,Ivy Shi,Pedro H Ribeiro,Juhi K Parekh,Athar Roshandelpoor,Chiadi Ndumele,Norrina B Allen,Sadiya S Khan,Bruce M Psaty,James S Floyd,Daniel Levy,Rudolf A de Boer,Navin Suthahar,Kevin Damman,Michelle C Odden,Ron T Gansevoort,Kunihiro Matsushita,Carine Hamo,Issa J Dahabreh,Robert W Yeh,Mahnaz Maddah,Shaan Khurshid,Patrick T Ellinor,Emily S Lau,Dhruv S Kazi,Jennifer E Ho
ImportanceThe prevalence of obesity and cardiovascular-kidney-metabolic (CKM) syndrome continues to rise. Indications for novel CKM therapies, including glucagonlike peptide 1 receptor agonists (GLP-1RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2is), and nonsteroidal mineralocorticoid antagonists (nsMRAs) continue to expand, yet the proportion of adults meeting expanded indications, including for multiple medications remains unclear.ObjectiveTo examine proportion of adults meeting US Food and Drug Administration (FDA)-approved indications for GLP1-RAs, SGLT2is, and nsMRAs across national survey, community-based, and ambulatory health care samples.Design, Setting, and ParticipantsThis study used a representative cross-sectional survey of US adults (National Health and Nutrition Examination Survey [NHANES], weighted 245 million; mean [SD] age, 47 [18] years; 126.8 million [52%] female), 5 pooled community-based cohort studies (the Framingham Heart Study, the Multi-Ethnic Study of Atherosclerosis, the Prevention of Renal and Vascular Endstage Disease Study, the Atherosclerosis Risk in Communities Study, and the Cardiovascular Health Study; n = 30 929; mean [SD] age, 63 [14] years; 16 749 [54%] female), and 2 ambulatory health care samples (the Beth Israel Deaconess Medical Center cohort [BIDMC], n = 84 714; mean [SD] age, 46 [17] years; 51 113 [60%] female] and the Mass General Brigham cohort [MGB], n = 362 485; mean [SD] age, 48 [17] years; 227 206 [61%] female). Data were analyzed from November 2024 to November 2025.ExposuresFDA-approved indications for GLP-1RAs, SGLT2is, and nsMRAs.Main Outcomes and MeasuresMedication class eligibility within each study sample.ResultsThe proportion of individuals who met current FDA-approved indications for 1 or more CKM medication was 60% in NHANES (representing 148 million US adults), 61% in the pooled cohorts, 42% in the BIDMC ambulatory cohort, and 46% in the MGB ambulatory cohort. Eligibility for GLP-1RA therapy was most common, with 56% (representing 137.1 million US adults) in NHANES, 49% in the pooled cohorts, 41% in the BIDMC cohort, and 46% in the MGB cohort. This was followed by SGLT2i therapy (24% [57.9 million] in NHANES, 33% in the pooled cohorts, 14% for both BIDMC and MGB) and nsMRA (5% [11.7 million] in NHANES, 5% in the pooled cohorts, and 1% to 2% in ambulatory samples). Overlapping eligibility for multiple classes was common, with 12% to 17% for GLP1-RA and SGLT2i therapies and 1% to 5% for all 3 classes (an estimated 11.7 million US adults in NHANES).Conclusions and RelevanceThis study found that up to 61% of adults met FDA-approved indications for at least 1 of 3 novel CKM therapy classes. This represents an estimated 148 million US adults, including 11.7 million US adults with potential FDA indications for triple therapy, highlighting the urgent need to optimize implementation and utilization of CKM syndrome therapies.
肥胖症和心血管肾代谢综合征（CKM）的患病率持续上升。新型CKM治疗的适应症，包括胰高血糖素样肽1受体激动剂（GLP-1RAs）、钠-葡萄糖共转运蛋白-2抑制剂（SGLT2is）和非甾体矿皮质激素拮抗剂（nsMRAs）继续扩大，但符合扩大适应症的成人比例，包括多种药物治疗仍不清楚。目的研究在全国调查、社区调查和门诊医疗样本中，符合美国食品和药物管理局（FDA）批准的GLP1-RAs、SGLT2is和nsra适应症的成年人比例。设计、环境和参与者本研究采用了一项具有代表性的美国成年人横断面调查（全国健康与营养调查[NHANES]，加权2.45亿；平均年龄[SD] 47岁；1.268亿[52%]女性），5项基于社区的队列研究(弗雷明汉心脏研究、多种族动脉粥样硬化研究、肾脏和血管终末期疾病预防研究、社区动脉粥样硬化风险研究和心血管健康研究；n = 30 929；平均[SD]年龄63岁；16例 749例[54%]女性)和2例门诊医疗样本（Beth Israel Deaconess Medical Center队列[BIDMC]， n = 84 714；平均[SD]年龄46亿岁；51例 113例[60%]女性]和麻省总医院Brigham队列[MGB]， n = 362 485；平均[SD]年龄48亿岁；227 206例[61%]女性）。数据分析时间为2024年11月至2025年11月。fda批准GLP-1RAs、SGLT2is和nsra的适应症。主要结果和测量方法每个研究样本的药物类别合格性。结果符合目前fda批准的1种或1种以上CKM药物适应症的个体比例在NHANES中为60%（代表1.48亿美国成年人），在合并队列中为61%，在BIDMC流动队列中为42%，在MGB流动队列中为46%。GLP-1RA治疗的资格是最常见的，在NHANES中有56%（代表1.371亿美国成年人），在合并队列中有49%，在BIDMC队列中有41%，在MGB队列中有46%。其次是SGLT2i治疗（在NHANES中占24%[5790万]，在合并队列中占33%，在BIDMC和MGB中占14%）和nsMRA（在NHANES中占5%[1170万]，在合并队列中占5%，在流动样本中占1%至2%）。多个类别的重叠资格很常见，GLP1-RA和SGLT2i治疗的重叠资格为12%至17%，所有3个类别的重叠资格为1%至5% （NHANES估计有1170万美国成年人）。结论和相关性本研究发现，高达61%的成年人符合fda批准的3种新型CKM治疗类别中至少1种的适应症。这意味着估计有1.48亿美国成年人，其中包括1170万美国成年人具有潜在的FDA三联疗法适应症，突出了优化CKM综合征治疗的实施和利用的迫切需要。
{"title":"Cardiovascular-Kidney-Metabolic Medication Eligibility Across National Survey, Community-Based, and Ambulatory Healthcare Samples.","authors":"Louisa A Mounsey,Mandana Chitsazan,Ivy Shi,Pedro H Ribeiro,Juhi K Parekh,Athar Roshandelpoor,Chiadi Ndumele,Norrina B Allen,Sadiya S Khan,Bruce M Psaty,James S Floyd,Daniel Levy,Rudolf A de Boer,Navin Suthahar,Kevin Damman,Michelle C Odden,Ron T Gansevoort,Kunihiro Matsushita,Carine Hamo,Issa J Dahabreh,Robert W Yeh,Mahnaz Maddah,Shaan Khurshid,Patrick T Ellinor,Emily S Lau,Dhruv S Kazi,Jennifer E Ho","doi":"10.1001/jamacardio.2025.5305","DOIUrl":"https://doi.org/10.1001/jamacardio.2025.5305","url":null,"abstract":"ImportanceThe prevalence of obesity and cardiovascular-kidney-metabolic (CKM) syndrome continues to rise. Indications for novel CKM therapies, including glucagonlike peptide 1 receptor agonists (GLP-1RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2is), and nonsteroidal mineralocorticoid antagonists (nsMRAs) continue to expand, yet the proportion of adults meeting expanded indications, including for multiple medications remains unclear.ObjectiveTo examine proportion of adults meeting US Food and Drug Administration (FDA)-approved indications for GLP1-RAs, SGLT2is, and nsMRAs across national survey, community-based, and ambulatory health care samples.Design, Setting, and ParticipantsThis study used a representative cross-sectional survey of US adults (National Health and Nutrition Examination Survey [NHANES], weighted 245 million; mean [SD] age, 47 [18] years; 126.8 million [52%] female), 5 pooled community-based cohort studies (the Framingham Heart Study, the Multi-Ethnic Study of Atherosclerosis, the Prevention of Renal and Vascular Endstage Disease Study, the Atherosclerosis Risk in Communities Study, and the Cardiovascular Health Study; n = 30 929; mean [SD] age, 63 [14] years; 16 749 [54%] female), and 2 ambulatory health care samples (the Beth Israel Deaconess Medical Center cohort [BIDMC], n = 84 714; mean [SD] age, 46 [17] years; 51 113 [60%] female] and the Mass General Brigham cohort [MGB], n = 362 485; mean [SD] age, 48 [17] years; 227 206 [61%] female). Data were analyzed from November 2024 to November 2025.ExposuresFDA-approved indications for GLP-1RAs, SGLT2is, and nsMRAs.Main Outcomes and MeasuresMedication class eligibility within each study sample.ResultsThe proportion of individuals who met current FDA-approved indications for 1 or more CKM medication was 60% in NHANES (representing 148 million US adults), 61% in the pooled cohorts, 42% in the BIDMC ambulatory cohort, and 46% in the MGB ambulatory cohort. Eligibility for GLP-1RA therapy was most common, with 56% (representing 137.1 million US adults) in NHANES, 49% in the pooled cohorts, 41% in the BIDMC cohort, and 46% in the MGB cohort. This was followed by SGLT2i therapy (24% [57.9 million] in NHANES, 33% in the pooled cohorts, 14% for both BIDMC and MGB) and nsMRA (5% [11.7 million] in NHANES, 5% in the pooled cohorts, and 1% to 2% in ambulatory samples). Overlapping eligibility for multiple classes was common, with 12% to 17% for GLP1-RA and SGLT2i therapies and 1% to 5% for all 3 classes (an estimated 11.7 million US adults in NHANES).Conclusions and RelevanceThis study found that up to 61% of adults met FDA-approved indications for at least 1 of 3 novel CKM therapy classes. This represents an estimated 148 million US adults, including 11.7 million US adults with potential FDA indications for triple therapy, highlighting the urgent need to optimize implementation and utilization of CKM syndrome therapies.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"102 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146056844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-28DOI: 10.1001/jamacardio.2025.5536
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