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Polypill with or without aspirin in persons without cardiovascular disease

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dc.contributor.authorYusuf, Salim
dc.contributor.authorJoseph, Philip
dc.contributor.authorDans, Antonio
dc.contributor.authorGao, Peggy
dc.contributor.authorTeo, Koon
dc.contributor.authorXavier, Denis
dc.contributor.authorLopez-Jaramillo, Patricio
dc.contributor.authorYusoff, Khalid
dc.contributor.authorSantoso, Anwar
dc.contributor.authorGamra, Habib
dc.contributor.authorTalukder, Shamim
dc.contributor.authorChristou, Courtney
dc.contributor.authorGirish, Preeti
dc.contributor.authorYeates, Karen
dc.contributor.authorXavier, Freeda
dc.contributor.authorDagenais, Gilles
dc.contributor.authorRocha, Catalina
dc.contributor.authorMcCready, Tara
dc.contributor.authorTyrwhitt, Jessica
dc.contributor.authorBosch, Jackie
dc.contributor.authorPais, Prem
dc.contributor.authorThe International Polycap Study 3 Investigators
dc.contributor.researchgroupMasiraspa
dc.date.accessioned2022-02-23T22:25:36Z
dc.date.available2022-02-23T22:25:36Z
dc.date.issued2021-01-21
dc.descriptionDigitalspa
dc.description.abstractBACKGROUND A polypill comprising statins, multiple blood-pressure–lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease. METHODS Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed. RESULTS A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups. CONCLUSIONS Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437. opens in new tab.)spa
dc.description.researchareaCiencias Médicas y de la Saludspa
dc.format.extent13 pspa
dc.format.mimetypeapplication/pdfspa
dc.identifier.doi10.1056/NEJMoa2028220
dc.identifier.urihttps://repositorio.udes.edu.co/handle/001/6139
dc.language.isoengspa
dc.publisherThe New England Journal of Medicinespa
dc.publisher.placeUSAspa
dc.relation.citationendpage228spa
dc.relation.citationissue3spa
dc.relation.citationstartpage216spa
dc.relation.citationvolume384spa
dc.relation.indexedScopusspa
dc.relation.ispartofjournalThe New England Journal of Medicinespa
dc.rightsCopyright © 2020 The Authors, Massachusetts Medical Society.spa
dc.rights.accessrightsinfo:eu-repo/semantics/openAccessspa
dc.rights.creativecommonsAtribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)spa
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/spa
dc.sourcehttps://www.nejm.org/doi/10.1056/NEJMoa2028220spa
dc.titlePolypill with or without aspirin in persons without cardiovascular diseasespa
dc.typeArtículo de revistaspa
dc.type.coarhttp://purl.org/coar/resource_type/c_6501spa
dc.type.contentTextspa
dc.type.driverinfo:eu-repo/semantics/articlespa
dc.type.redcolhttp://purl.org/redcol/resource_type/ARTspa
dc.type.versioninfo:eu-repo/semantics/publishedVersionspa
dcterms.audienceTodas las Audienciasspa
dspace.entity.typePublication
oaire.accessrightshttp://purl.org/coar/access_right/c_abf2spa
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85spa
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