dc.contributor.author | Castellano, Jose Maria | |
dc.contributor.author | Pocock, Stuart J | |
dc.contributor.author | Bhatt, Deepak L | |
dc.contributor.author | Quesada, Antonio J | |
dc.contributor.author | Owen, Ruth | |
dc.contributor.author | Fernandez-Ortiz, Antonio | |
dc.contributor.author | Molina-Sanchez, Pedro | |
dc.contributor.author | Marin Ortuño, Francisco | |
dc.contributor.author | Vazquez Rodriguez, Jose M | |
dc.contributor.author | Domingo-Fernández, Alexandra | |
dc.contributor.author | Lozano, Iñigo | |
dc.contributor.author | Roncaglioni, Maria C | |
dc.contributor.author | Baviera, Marta | |
dc.contributor.author | Foresta, Andreana | |
dc.contributor.author | Ojeda-Fernandez, Luisa | |
dc.contributor.author | Colivicchi, Furio | |
dc.contributor.author | Di Fusco, Stefania A | |
dc.contributor.author | Doehner, Wolfram | |
dc.contributor.author | Meyer, Antje | |
dc.contributor.author | Schiele, François | |
dc.contributor.author | Ecarnot, Fiona | |
dc.contributor.author | Linhart, Aleš | |
dc.contributor.author | Lubanda, Jean-Claude | |
dc.contributor.author | Barczi, Gyorgy | |
dc.contributor.author | Merkely, Bela | |
dc.contributor.author | Ponikowski, Piotr | |
dc.contributor.author | Kasprzak, Marta | |
dc.contributor.author | Fernandez-Alvira, Juan Miguel | |
dc.contributor.author | Andres, Vicente | |
dc.contributor.author | Bueno, Hector | |
dc.contributor.author | Collier, Timothy | |
dc.contributor.author | Van de Werf, Frans | |
dc.contributor.author | Perel, Pablo | |
dc.contributor.author | Rodriguez-Manero, Moises | |
dc.contributor.author | Alonso Garcia, Angeles | |
dc.contributor.author | Proietti, Marco | |
dc.contributor.author | Schoos, Mikkel M | |
dc.contributor.author | Simon, Tabassome | |
dc.contributor.author | Fernandez Ferro, Jose | |
dc.contributor.author | Lopez, Nicolas | |
dc.contributor.author | Beghi, Ettore | |
dc.contributor.author | Bejot, Yannick | |
dc.contributor.author | Vivas, David | |
dc.contributor.author | Cordero, Alberto | |
dc.contributor.author | Ibáñez, Borja | |
dc.contributor.author | Fuster, Valentin | |
dc.date.accessioned | 2023-09-15T10:18:32Z | |
dc.date.available | 2023-09-15T10:18:32Z | |
dc.date.issued | 2022-09-15 | |
dc.identifier.citation | N Engl J Med. 2022 Sep 15;387(11):967-977. | es_ES |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/16468 | |
dc.description.abstract | BACKGROUND
A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction.
METHODS
In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke.
RESULTS
A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups.
CONCLUSIONS
Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.). | es_ES |
dc.description.sponsorship | Supported by a grant (633765) from the European Union Horizon 2020 research and innovation program. Centro Nacional
de Investigaciones Cardiovasculares (CNIC), a nonprofit public
institution, is supported by Instituto de Salud Carlos III, the
Ministerio de Ciencia e Innovación, and the Pro CNIC Foundation and is a Severo Ochoa Center of Excellence (grant CEX2020-
001041-S funded by MICIN/AEI/10.13039/501100011033). CNIC
receives royalties for the sales of the polypill from Ferrer International. In Spain, project management and monitoring
was performed the Spanish Clinical Research Network, a public
network funded by Instituto de Salud Carlos III (grant numbers
PTC20/00018 and PT17/0017); the State Plan for Research,
Development, and Innovation 2013–16; the State Plan for Scientific and Technical Research and Innovation 2017–20; and
the Subdirectorate General for Evaluation and Promotion of
Research, with cofunding from the European Regional Development Fund.
Disclosure forms provided by the authors are available with
the full text of this article at NEJM.org.
A data sharing statement provided by the authors is available
with the full text of this article at NEJM.org. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Massachusetts Medical Society | es_ES |
dc.type.hasVersion | VoR | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject.mesh | Angiotensin-Converting Enzyme Inhibitors | es_ES |
dc.subject.mesh | Cardiovascular Diseases | es_ES |
dc.subject.mesh | Hydroxymethylglutaryl-CoA Reductase Inhibitors | es_ES |
dc.subject.mesh | Platelet Aggregation Inhibitors | es_ES |
dc.subject.mesh | Aspirin | es_ES |
dc.subject.mesh | Atorvastatin | es_ES |
dc.subject.mesh | Humans | es_ES |
dc.subject.mesh | Ischemic Stroke | es_ES |
dc.subject.mesh | Myocardial Infarction | es_ES |
dc.subject.mesh | Ramipril | es_ES |
dc.subject.mesh | Secondary Prevention | es_ES |
dc.title | Polypill Strategy in Secondary Cardiovascular Prevention. | es_ES |
dc.type | journal article | es_ES |
dc.rights.license | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.identifier.pubmedID | 36018037 | es_ES |
dc.format.volume | 387 | es_ES |
dc.format.number | 11 | es_ES |
dc.format.page | 967 | es_ES |
dc.identifier.doi | 10.1056/NEJMoa2208275 | es_ES |
dc.contributor.funder | Unión Europea. Comisión Europea. H2020 | es_ES |
dc.contributor.funder | Centro Nacional de Investigaciones Cardiovasculares Carlos III (España) | es_ES |
dc.contributor.funder | Instituto de Salud Carlos III | es_ES |
dc.contributor.funder | Ministerio de Ciencia e Innovación (España) | es_ES |
dc.contributor.funder | Fundación ProCNIC | es_ES |
dc.contributor.funder | Ministerio de Ciencia e Innovación. Centro de Excelencia Severo Ochoa (España) | es_ES |
dc.contributor.funder | Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF) | es_ES |
dc.contributor.funder | Ferrer | es_ES |
dc.description.peerreviewed | Sí | es_ES |
dc.identifier.e-issn | 1533-4406 | es_ES |
dc.identifier.journal | The New England journal of medicine | es_ES |
dc.repisalud.institucion | CNIC | es_ES |
dc.relation.projectID | info:eu-repo/grantAgreement/EC/H2020/633765 | es_ES |
dc.rights.accessRights | open access | es_ES |
dc.relation.projectFECYT | info:eu-repo/grantAgreement/ES/MICIN/AEI/10.13039/501100011033/CEX2020-001041-S | es_ES |
dc.relation.projectFECYT | info:eu-repo/grantAgreement/ES/PTC20/00018 | es_ES |
dc.relation.projectFECYT | info:eu-repo/grantAgreement/ES/PT17/0017 | es_ES |