{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T14:04:23Z","timestamp":1794319463427,"version":"4.9.0"},"reference-count":44,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T00:00:00Z","timestamp":1726790400000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"VIDI Fellowship from the Dutch Organisation for Health Research and Development","award":["09150172010050"],"award-info":[{"award-number":["09150172010050"]}]},{"name":"NIH\/NHLBI","award":["K99HL157687"],"award-info":[{"award-number":["K99HL157687"]}]},{"name":"NIH\/NHLBI","award":["2020144"],"award-info":[{"award-number":["2020144"]}]},{"DOI":"10.13039\/100000862","name":"Doris Duke Charitable Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000862","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>The polypill is an emerging strategy for the prevention and management of cardiovascular disease (CVD). We assessed the participation of females in randomized controlled trials evaluating polypills for prevention of CVD and subsequent sex-specific analyses and reporting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>Cardiovascular polypill trials were identified through a systematic review. Data were extracted on the use of sex-specific eligibility criteria, female participation, and the conduct, findings, and interpretation of sex-specific analyses. Of 26 trials included, 12 (46%) excluded groups of females, mainly if pregnant or lactating or of childbearing potential. Female participation ranged from 10% to 73% across trials. Overall, 42% of included participants were female. Of 18 trials conducted in a mostly primary prevention population, females represented 49% of trial participants. In mixed or exclusively secondary prevention trials (n = 8), females represented 26% of trial participants. Females represented 46% of trial participants in trials that excluded groups of females (n = 12). In trials without explicit exclusion criteria (n = 13), females represented 32% of trial participants. Nine out of 26 trials reported sex-stratified analyses (35% of trials; 70% of all participants). Of these, two found some evidence for possible sex differences, both reporting larger blood pressure effects in females than males. Four trials provided sex considerations in the discussion section of the report.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The participation of females in cardiovascular polypill trials is substantially higher in primary prevention trials as compared with trials conducted in mixed or exclusively secondary prevention populations. The use of sex-specific eligibility criteria was not linked to lower female participation. Sex-specific reporting is sparsely conducted, although most frequent in larger trials.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/eurjpc\/zwae307","type":"journal-article","created":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T18:14:32Z","timestamp":1726856072000},"source":"Crossref","is-referenced-by-count":1,"title":["Female participation, and sex-specific reporting practices, in polypill randomized controlled trials in the prevention of atherosclerotic cardiovascular disease: a secondary analysis of a systematic review"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0346-5412","authenticated-orcid":false,"given":"Sanne A E","family":"Peters","sequence":"first","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University , PO Box 85500, 3508 GA, Utrecht ,","place":["The Netherlands"]},{"name":"School of Public Health, Imperial College London, The George Institute for Global Health , London ,","place":["UK"]},{"name":"The George Institute for Global Health, University of New South Wales , Sydney, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Rodgers","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health, University of New South Wales , Sydney, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3825-4092","authenticated-orcid":false,"given":"Anushka","family":"Patel","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health, University of New South Wales , Sydney, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3988-315X","authenticated-orcid":false,"given":"Robyn","family":"Norton","sequence":"additional","affiliation":[{"name":"School of Public Health, Imperial College London, The George Institute for Global Health , London ,","place":["UK"]},{"name":"The George Institute for Global Health, University of New South Wales , Sydney, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark D","family":"Huffman","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health, University of New South Wales , Sydney, New South Wales ,","place":["Australia"]},{"name":"Division of Cardiology and Global Health Center, Washington University in St. Louis , St. Louis, MO ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anubha","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Division of Cardiology and Global Health Center, Washington University in St. Louis , St. Louis, MO 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Is there any interaction among the monocomponents?","volume":"74","author":"Gonz\u00e1lez-Juanatey","year":"2021","journal-title":"Rev Esp Cardiol (Engl Ed)"},{"key":"2024101705155904300_zwae307-B33","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1056\/NEJMoa2028220","article-title":"Polypill with or without Aspirin in persons without cardiovascular disease","volume":"384","author":"Yusuf","year":"2021","journal-title":"N Engl J Med"},{"key":"2024101705155904300_zwae307-B34","doi-asserted-by":"crossref","first-page":"2023","DOI":"10.1093\/eurheartj\/ehab919","article-title":"Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-liver trial","volume":"43","author":"Merat","year":"2022","journal-title":"Eur Heart J"},{"key":"2024101705155904300_zwae307-B35","doi-asserted-by":"crossref","first-page":"967","DOI":"10.1056\/NEJMoa2208275","article-title":"Polypill strategy in secondary cardiovascular prevention","volume":"387","author":"Castellano","year":"2022","journal-title":"N Engl J Med"},{"key":"2024101705155904300_zwae307-B36","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1016\/S0140-6736(19)31791-X","article-title":"Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial","volume":"394","author":"Roshandel","year":"2019","journal-title":"Lancet"},{"key":"2024101705155904300_zwae307-B37","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1161\/CIRCOUTCOMES.110.868307","article-title":"Representation of women in randomized clinical trials of cardiovascular disease prevention","volume":"3","author":"Melloni","year":"2010","journal-title":"Circ Cardiovasc Qual Outcomes"},{"key":"2024101705155904300_zwae307-B38","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1093\/eurjcn\/zvad048","article-title":"Factors affecting women's participation in cardiovascular research: a scoping review","volume":"23","author":"Matthews","year":"2024","journal-title":"Eur J Cardiovasc Nurs"},{"key":"2024101705155904300_zwae307-B39","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1161\/CIRCULATIONAHA.119.042909","article-title":"Women representation among cardiology journal editorial boards","volume":"141","author":"Balasubramanian","year":"2020","journal-title":"Circulation"},{"key":"2024101705155904300_zwae307-B40","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1001\/jamainternmed.2020.2485","article-title":"Representation of women in cardiovascular clinical trial leadership","volume":"180","author":"Denby","year":"2020","journal-title":"JAMA Intern Med"},{"key":"2024101705155904300_zwae307-B41","doi-asserted-by":"crossref","first-page":"931","DOI":"10.1177\/1747493019851292","article-title":"Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke","volume":"14","author":"Carcel","year":"2019","journal-title":"Int J Stroke"},{"key":"2024101705155904300_zwae307-B42","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1038\/d41586-020-03459-y","article-title":"Accounting for sex and gender makes for better science","volume":"588","year":"2020","journal-title":"Nature"},{"key":"2024101705155904300_zwae307-B43","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1186\/s12916-023-03060-w","article-title":"A roadmap for sex- and gender-disaggregated health research","volume":"21","author":"Peters","year":"2023","journal-title":"BMC Med"},{"key":"2024101705155904300_zwae307-B44","doi-asserted-by":"crossref","first-page":"1863","DOI":"10.1001\/jama.2016.16405","article-title":"Reporting sex, gender, or both in clinical research?","volume":"316","author":"Clayton","year":"2016","journal-title":"JAMA"}],"container-title":["European Journal of Preventive Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/eurjpc\/advance-article-pdf\/doi\/10.1093\/eurjpc\/zwae307\/59814446\/zwae307.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/eurjpc\/advance-article-pdf\/doi\/10.1093\/eurjpc\/zwae307\/59814446\/zwae307.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T05:17:01Z","timestamp":1729142221000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eurjpc\/advance-article\/doi\/10.1093\/eurjpc\/zwae307\/7762847"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,20]]},"references-count":44,"URL":"https:\/\/doi.org\/10.1093\/eurjpc\/zwae307","relation":{},"ISSN":["2047-4873","2047-4881"],"issn-type":[{"value":"2047-4873","type":"print"},{"value":"2047-4881","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,20]]},"article-number":"zwae307"}}