JAMA cardiologyPub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.4806
Marko Lucijanic, Eugen Javor, Marko Skelin
{"title":"Sex Differences in the Effectiveness and Safety of Aspirin.","authors":"Marko Lucijanic, Eugen Javor, Marko Skelin","doi":"10.1001/jamacardio.2024.4806","DOIUrl":"10.1001/jamacardio.2024.4806","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"201"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914420","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}
JAMA cardiologyPub Date : 2025-02-01DOI: 10.1001/jamacardio.2025.0009
{"title":"Error in Abstract and Results.","authors":"","doi":"10.1001/jamacardio.2025.0009","DOIUrl":"10.1001/jamacardio.2025.0009","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"10 2","pages":"202"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2025-01-29DOI: 10.1001/jamacardio.2024.5281
Catherine Pollak, Andrew Parambath, Samantha Coratti, Laurie Norton, Anthony Girard, Catherine Reitz, Christopher K. Snider, Lin Xu, Zakiya Walker, Aileen John, Mary E. Putt, Kevin G. Volpp, Shivan J. Mehta
{"title":"Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening","authors":"Catherine Pollak, Andrew Parambath, Samantha Coratti, Laurie Norton, Anthony Girard, Catherine Reitz, Christopher K. Snider, Lin Xu, Zakiya Walker, Aileen John, Mary E. Putt, Kevin G. Volpp, Shivan J. Mehta","doi":"10.1001/jamacardio.2024.5281","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5281","url":null,"abstract":"ImportanceA comprehensive lipid panel is recommended by guidelines to evaluate atherosclerotic cardiovascular disease risk, but uptake is low.ObjectiveTo evaluate whether direct outreach including bulk orders with and without text messaging increases lipid screening rates.Design, Setting, and ParticipantsPragmatic randomized clinical trial conducted from June 6, 2023, to September 6, 2023, at 2 primary care practices at an academic health system among patients aged 20 to 75 years with at least 1 primary care visit in the past 3 years who were overdue for lipid screening. Data analysis was performed from September 2023 to May 2024.InterventionsEligible patients were randomized in a 1:2:2 ratio to usual care (group 1), direct outreach and bulk orders (group 2), and bulk order outreach with additional text message reminders for scheduling assistance (group 3). In group 3, participants received an initial, follow-up, and reminder text message. Patients with electronic portal accounts were encouraged to schedule through them, while others received laboratory contact information. Any participant inquiries were answered either with automated responses for common questions or with study team support.Main Outcomes and MeasuresProportion of patients who completed a lipid panel within 3 months.ResultsAmong the 1000 participants, the median (IQR) age was 38 (28-55) years; 470 (47.0%) were female; and 22 (2.3%) were Asian, 38 (3.9%) were Black, 32 (3.2%) were Hispanic or Latino, and 862 (88.6%) were White (race and ethnicity were based on self-reported data). At 3 months, a lipid panel was completed by 12 of 202 patients (5.9%; 95% CI, 3.4% to 10.1%) receiving usual care (group 1) vs 62 of 394 patients (15.7%; 95% CI, 12.5% to 19.7%) receiving direct outreach and bulk order (group 2), a difference of 9.8 percentage points (95% CI, 4.6 to 15.0; <jats:italic>P</jats:italic> = .001). The panel was completed by 73 of 404 patients (18.1%; 95% CI, 14.6% to 22.1%) receiving outreach, bulk order, and text message reminders (group 3), for a difference of 2.4 percentage points (95% CI, −3.1 to 7.8; <jats:italic>P</jats:italic> = .43) vs outreach with bulk order alone (group 2). At 6 months, there were no significant differences in lipid screening between either group 1 vs group 2 or group 2 vs group 3.Conclusions and RelevanceLipid screening among participants receiving bulk orders and outreach letters increased significantly compared with usual care at 3 months. However, there was no difference at 6 months. More than 80% of patients did not follow through with lipid screening despite the intervention, and there was no additional increase in lipid testing at 3 months among participants receiving bulk ordering and supplemental text messaging.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT05724615\">NCT05724615</jats:ext-link>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"22 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056293","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}
JAMA cardiologyPub Date : 2025-01-29DOI: 10.1001/jamacardio.2024.5124
Herry Mapesi, Martin Rohacek, Fiona Vanobberghen, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Jacqueline Nkouabi, Geofrey Mbunda, Jamali Siru, Ayesha Tarr, Elsie Ramapepe, Madavida Mphunyane, Johanna Oehri, Valeriya Nemtsova, Xiaohan Yan, Moniek Bresser, Tracy Renée Glass, Daniel Henry Paris, Günther Fink, Winfrid Gingo, Niklaus Daniel Labhardt, Thilo Burkard, Maja Weisser
{"title":"Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho","authors":"Herry Mapesi, Martin Rohacek, Fiona Vanobberghen, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Jacqueline Nkouabi, Geofrey Mbunda, Jamali Siru, Ayesha Tarr, Elsie Ramapepe, Madavida Mphunyane, Johanna Oehri, Valeriya Nemtsova, Xiaohan Yan, Moniek Bresser, Tracy Renée Glass, Daniel Henry Paris, Günther Fink, Winfrid Gingo, Niklaus Daniel Labhardt, Thilo Burkard, Maja Weisser","doi":"10.1001/jamacardio.2024.5124","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5124","url":null,"abstract":"ImportanceHypertension is the primary cardiovascular risk factor in Africa. Recently revised World Health Organization guidelines recommend starting antihypertensive dual therapy; clinical efficacy and tolerability of low-dose triple combination remain unclear.ObjectivesTo compare the effect of 3 treatment strategies on blood pressure control among persons with untreated hypertension in Africa.Design, Setting, and ParticipantsThis was an open-label, parallel, 3-arm randomized clinical trial to evaluate noninferiority of a strategy starting 2 pills vs full-dose monotherapy with stepped escalation (noninferiority margin 10%) and superiority of starting low-dose 3 pills vs monotherapy allowing for monthly up titration. Recruitment lasted from March 5, 2020, to March 30, 2022. The setting was 2 hospitals in rural Lesotho and Tanzania. Participants included nonpregnant Black African individuals 18 years and older with uncomplicated, untreated hypertension (standardized office blood pressure ≥140 mm Hg systolic or ≥90 mm Hg diastolic).InterventionsParticipants were randomized 2:2:1 to stepped monotherapy (amlodipine, 10 mg, with escalation to add hydrochlorothiazide if needed), 2-pill strategy (amlodipine, 5 mg; losartan, 25 mg), or 3-pill strategy (amlodipine, 2.5 mg; losartan, 12.5 mg; hydrochlorothiazide, 6.25 mg). Drugs were up titrated monthly until reaching the target blood pressure (≤ 130/80 mm Hg for participants aged &amp;lt;65 years; ≤140/90 mm Hg for those aged ≥65 years).Main Outcomes and MeasuresProportion of participants reaching target blood pressure at 12 weeks.ResultsOf 1761 participants screened, 1268 were enrolled (median [IQR] age, 54 [45-65] years; 914 female [72%]), with 505 in the monotherapy cohort, 510 in the 2-pill cohort, and 253 in the 3-pill cohort. In noninferiority analyses, 207 of 370 participants (56%) receiving the 2-pill strategy and 173 of 338 participants (51%) receiving the stepped monotherapy strategy achieved the blood pressure target (adjusted odds ratio [aOR], 1.18; 95% CI, 0.87-1.61), fulfilling noninferiority. In superiority analyses after multiple imputation for missing outcome data, 57% of participants receiving the 3-pill strategy, 55% receiving the 2-pill strategy, and 49% receiving the stepped monotherapy strategy reached the target blood pressure (aOR, 1.24; 95% CI, 0.94-1.63; <jats:italic>P</jats:italic> = .12 and aOR, 1.28; 95% CI, 0.91-1.79; <jats:italic>P</jats:italic> = .16 for the 2-pill and 3-pill vs stepped monotherapy strategies, respectively).Conclusions and RelevanceResults of this randomized clinical trial show that in 2 African settings, for adults with uncomplicated untreated hypertension, a strategy starting a 2-pill low-dose treatment was noninferior to starting stepped monotherapy. Two-pill and 3-pill low-dose strategies were not superior to stepped monotherapy. Wide CIs preclude the ability to rule out potentially clinically important effects of the additional pill strategies for h","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"1 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056250","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}
JAMA cardiologyPub Date : 2025-01-29DOI: 10.1001/jamacardio.2024.5278
Erica S Spatz,Jeremy I Schwartz,Thomas R Frieden
{"title":"Blood Pressure Control-Many Paths, 1 Goal.","authors":"Erica S Spatz,Jeremy I Schwartz,Thomas R Frieden","doi":"10.1001/jamacardio.2024.5278","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5278","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"82 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056836","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}
JAMA cardiologyPub Date : 2025-01-22DOI: 10.1001/jamacardio.2024.5221
Aldostefano Porcari, Yousuf Razvi, Francesco Cappelli, Christian Nitsche, Matteo Serenelli, Simone Longhi, Giulio Sinigiani, Alberto Cipriani, Alberto Aimo, Daniela Tomasoni, Mattia Zampieri, Anna Cantone, Valentina Allegro, Giuseppe Vergaro, Ahmad Masri, Marcus Urey, Adam Ioannou, Aviva Petrie, Navid Noory, Finn Gustafsson, Michael Poledniczek, Michele Emdin, Marco Metra, Gianfranco Sinagra, Ana Martinez-Naharro, Ashutosh D Wechalekar, Helen Lachman, Carol Whelan, Philip N Hawkins, Scott D Solomon, Julian D Gillmore, Marianna Fontana
{"title":"Clinical Phenotype and Prognosis of Asymptomatic Patients With Transthyretin Cardiac Amyloid Infiltration.","authors":"Aldostefano Porcari, Yousuf Razvi, Francesco Cappelli, Christian Nitsche, Matteo Serenelli, Simone Longhi, Giulio Sinigiani, Alberto Cipriani, Alberto Aimo, Daniela Tomasoni, Mattia Zampieri, Anna Cantone, Valentina Allegro, Giuseppe Vergaro, Ahmad Masri, Marcus Urey, Adam Ioannou, Aviva Petrie, Navid Noory, Finn Gustafsson, Michael Poledniczek, Michele Emdin, Marco Metra, Gianfranco Sinagra, Ana Martinez-Naharro, Ashutosh D Wechalekar, Helen Lachman, Carol Whelan, Philip N Hawkins, Scott D Solomon, Julian D Gillmore, Marianna Fontana","doi":"10.1001/jamacardio.2024.5221","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5221","url":null,"abstract":"<p><strong>Importance: </strong>Patients with transthyretin (ATTR) cardiac amyloid infiltration are increasingly diagnosed at earlier disease stages with no heart failure (HF) symptoms and a wide range of cardiac amyloid infiltration.</p><p><strong>Objective: </strong>To characterize the clinical phenotype and natural history of asymptomatic patients with ATTR cardiac amyloid infiltration.</p><p><strong>Design, setting, and participants: </strong>This cohort study analyzed data of all patients at 12 international centers for amyloidosis from January 1, 2008, through December 31, 2023. Inclusion criteria were asymptomatic ATTR cardiac amyloid infiltration, defined as an absence of HF history, HF signs and symptoms, diuretic therapy, and plasma cell dyscrasia with evidence of myocardial uptake on bone scintigraphy. If plasma cell dyscrasia was present, histologic confirmation of ATTR amyloid was required.</p><p><strong>Exposure: </strong>Asymptomatic ATTR cardiac amyloid infiltration.</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were all-cause and cardiovascular (CV) mortality. The secondary outcomes were unplanned HF hospitalization, unplanned CV-related hospitalization, and a composite outcome of CV mortality and HF hospitalization.</p><p><strong>Results: </strong>The study comprised 485 patients with asymptomatic ATTR cardiac amyloid infiltration (mean [SD] age, 74.9 [9.9] years, 85.8% male, 112 [23.1%] with hereditary ATTR amyloidosis), with 369 (76.1%) having grade 2 or 3 and 116 (23.9%) having grade 1 cardiac uptake at baseline. Patients with grade 2 or 3 uptake exhibited significantly more cardiac functional and structural abnormalities vs patients with grade 1 uptake. At 3 years, compared with grade 1 uptake, patients with grade 2 or 3 uptake had greater development of HF (54.3% [95% CI, 47.7%-61.3%] vs 23.1% [95% CI, 14.8%-35.1%]), greater outpatient diuretic initiation and N-terminal pro-B-type natriuretic peptide progression (35.0% [95% CI, 28.0%-43.2%] vs 12.4% [95% CI, 6.3%-23.7%]), and greater HF hospitalization (8.7% [95% CI, 5.9%-12.9%] vs 0%) and unplanned CV hospitalization (20.0% [95% CI, 15.7%-25.3%] vs 4.3% [95% CI, 1.6%-11.3%]). Over a median follow-up of 37 months (IQR, 20-64 months), the all-cause death rate was similar between patients with grade 1 vs 2 and 3 uptake; however, those with grade 2 or 3 compared with grade 1 uptake had a significantly higher risk of CV mortality (unadjusted hazard ratio, 5.30; 95% CI, 1.92-14.65).</p><p><strong>Conclusions and relevance: </strong>This study shows that asymptomatic ATTR cardiac amyloid infiltration encompasses a wide spectrum of disease severity, with patients with grade 2 or 3 cardiac uptake experiencing an increased rate of CV events and CV mortality and patients with grade 1 uptake experiencing a lower CV event rate and predominantly non-CV mortality. These findings support the use of disease-modifying treatments in asymptomatic patients with grade ","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005551","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}
JAMA cardiologyPub Date : 2025-01-08DOI: 10.1001/jamacardio.2024.4812
Ciaran N. Kohli-Lynch, Andrew E. Moran, Dhruv S. Kazi, Kirsten Bibbins-Domingo, Neil Jordan, Dustin French, Yiyi Zhang, Thomas J. Wang, Brandon K. Bellows
{"title":"Cost-Effectiveness of a Polypill for Cardiovascular Disease Prevention in an Underserved Population","authors":"Ciaran N. Kohli-Lynch, Andrew E. Moran, Dhruv S. Kazi, Kirsten Bibbins-Domingo, Neil Jordan, Dustin French, Yiyi Zhang, Thomas J. Wang, Brandon K. Bellows","doi":"10.1001/jamacardio.2024.4812","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.4812","url":null,"abstract":"ImportanceThe Southern Community Cohort Study (SCCS) Polypill Trial showed that a cardiovascular polypill (a single pill containing a statin and 3 half-standard dose antihypertensive medications) effectively controls cardiovascular disease (CVD) risk factors in a majority Black race and low-income population. The cost-effectiveness of polypill treatment in this population has not been previously studied.ObjectiveTo determine the cost-effectiveness of the cardiovascular polypill.Design, Setting, and ParticipantsA discrete-event simulation version of the well-established CVD policy model simulated clinical and economic outcomes of the SCCS Polypill Trial from a health care sector perspective. A time horizon of 10 years was adopted. Polypill treatment was priced at $463 per year in the base-case analysis. Model input data were derived from the National Health and Nutrition Examination Survey, Medical Expenditure Panel Survey, pooled longitudinal cohort studies, the SCCS Polypill Trial, and published literature. Two cohorts were analyzed: an SCCS Polypill Trial–representative cohort of 100 000 individuals and all trial-eligible non-Hispanic Black US adults. Study parameters and model inputs were varied extensively in 1-way and probabilistic sensitivity analysis.ExposuresPolypill treatment or usual care.Main Outcome and MeasuresPrimary outcomes were direct health care costs (US dollar 2023) and quality-adjusted life-years (QALYs), both discounted 3% annually, and the incremental cost per QALY gained.ResultsIn the trial-representative cohort of 100 000 individuals (mean [SD] age, 56.9 [5.9] years; 61 807 female [61.8%]), polypill treatment was projected to yield a mean of 1190 (95% uncertainty interval, 287-2159) additional QALYs compared with usual care, at a cost of approximately $10 152 000. Hence, polypill treatment was estimated to cost $8560 per QALY gained compared with usual care and was high value (&amp;lt;$50 000 per QALY gained) in 99% of simulations. Polypill treatment was estimated to be high value when priced at $559 or less per year and cost saving when priced at $443 or less per year. In almost all sensitivity analyses, polypill treatment remained high value. In a secondary analysis of 3 602 427 trial-eligible non-Hispanic Black US adults (mean [SD] age, 55.4 [7.6] years; 2 006 597 female [55.7%]), polypill treatment was high value, with an estimated cost of $13 400 per QALY gained.Conclusions and RelevanceResults of this economic evaluation suggest that polypill treatment could be a high value intervention for a low-income, majority Black population with limited access to health care services. It could additionally reduce health disparities.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"30 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142936291","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}
JAMA cardiologyPub Date : 2025-01-08DOI: 10.1001/jamacardio.2024.4823
Ushasi Saraswati, Jaideep Singh Bhalla, Allan L. Klein
{"title":"Recurrent Chest Pain in a Young Female Patient With Family History of Cancer","authors":"Ushasi Saraswati, Jaideep Singh Bhalla, Allan L. Klein","doi":"10.1001/jamacardio.2024.4823","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.4823","url":null,"abstract":"A female patient presents with chest pain, and echocardiography reveals moderate circumferential pericardial effusion, leading to a diagnosis of acute pericarditis. Initial cardiac magnetic resonance imaging phase-sensitive inversion recovery sequences in the sagittal section depict late gadolinium enhancement on the pericardium and pericardial thickening. What would you do next?","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"48 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142936292","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}
JAMA cardiologyPub Date : 2025-01-01DOI: 10.1001/jamacardio.2024.4613
Misato Chimura, Xiaowen Wang, Pardeep S Jhund, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S P Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray
{"title":"Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.","authors":"Misato Chimura, Xiaowen Wang, Pardeep S Jhund, Alasdair D Henderson, Brian L Claggett, Akshay S Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S P Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray","doi":"10.1001/jamacardio.2024.4613","DOIUrl":"10.1001/jamacardio.2024.4613","url":null,"abstract":"<p><strong>Importance: </strong>Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex.</p><p><strong>Objective: </strong>To estimate the efficacy and safety of finerenone compared with placebo in both women and men.</p><p><strong>Design, setting, and participants: </strong>Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF). The trial was conducted across 653 sites in 37 countries. Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023.</p><p><strong>Intervention: </strong>Finerenone (titrated to 20 mg or 40 mg) or placebo.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits).</p><p><strong>Results: </strong>A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P<.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]). The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men (P = .41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex (P = .73 for interaction). Finerenone had similar tolerability in women and men.</p><p><strong>Conclusions and relevance: </strong>In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04435626.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"59-70"},"PeriodicalIF":14.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}