Cited by 334Acute Myocardial Infarction ResearchAntiplatelet Therapy and Cardiovascular DiseasesLipoproteins and Cardiovascular Health

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Polypill Strategy in Secondary Cardiovascular Prevention

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Castellano, Jose M., Pocock, Stuart J., Bhatt, Deepak L., Quesada, Antonio J., Owen, Ruth, Fernandez-Ortiz, Antonio, Sanchez, Pedro L., Marin Ortuño, Francisco, Vazquez Rodriguez, Jose M., Domingo-Fernández, Alexandra, Lozano, Iñigo, Roncaglioni, Maria C., Baviera, Marta, Foresta, Andreana, Ojeda-Fernandez, Luisa, Colivicchi, Furio, Di Fusco, Stefania A., Doehner, Wolfram, Meyer, Antje, Schiele, François, Ecarnot, Fiona, Linhart, Aleš, Lubanda, Jean-Claude, Barczi, Gyorgy, Merkely, Bela, Ponikowski, Piotr, Kasprzak, Marta, Fernandez Alvira, Juan M., Andres, Vicente, Bueno, Hector, Collier, Timothy, Van de Werf, Frans, Perel, Pablo, Rodriguez-Manero, Moises, Alonso Garcia, Angeles, Proietti, Marco, Schoos, Mikkel M., Simon, Tabassome, Fernandez Ferro, Jose, Lopez, Nicolas, Beghi, Ettore, Bejot, Yannick, Vivas, David, Cordero, Alberto, Ibañez, Borja, Fuster, Valentin·2022·New England Journal of Medicine

DOI 10.1056/nejmoa2208275

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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.).

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Authors: Castellano, J. M., Pocock, S. J., Bhatt, D. L., Quesada, A. J., Owen, R., Fernandez-Ortiz, A., Sanchez, P. L., Marin Ortuño, F., Vazquez Rodriguez, J. M., Domingo-Fernández, A., Lozano, I., Roncaglioni, M. C., Baviera, M., Foresta, A., Ojeda-Fernandez, L., Colivicchi, F., Di Fusco, S. A., Doehner, W., Meyer, A., Schiele, F., Ecarnot, F., Linhart, A., Lubanda, J.-C., Barczi, G., Merkely, B., Ponikowski, P., Kasprzak, M., Fernandez Alvira, J. M., Andres, V., Bueno, H., Collier, T., Van de Werf, F., Perel, P., Rodriguez-Manero, M., Alonso Garcia, A., Proietti, M., Schoos, M. M., Simon, T., Fernandez Ferro, J., Lopez, N., Beghi, E., Bejot, Y., Vivas, D., Cordero, A., Ibañez, B., & Fuster, V.
Affiliations: Spanish National Centre for Cardiovascular Research (ES)
Brigham and Women's Hospital (US)
Hospital Clínico San Carlos (ES)
From Centro Nacional de Investigaciones Cardiovasculares (J.M.C., S.J.P., A.J.Q., A.F.-O., J.M.F.A., V.A., H.B., J.F.F., B.I., V.F.), Centro Integral de Enfermedades Cardiovasculares, Hospital Universitario Monteprincipe, Grupo HM Hospitales (J.M.C.), Hospital Clínico San Carlos, Universidad Complutense (A.F.-O., D.V.), Centro de Investigacion Biomedica en Red de Enfermedades Cardiovasculares (A.F.-O., P.L.S., F.M.O., J.M.V.R., V.A., H.B., A.C., B.I.), Unidad de Investigación Clínica y Ensayos Clínicos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (A.D.-F.), Health Research Institute, October 12 Hospital (H.B.), Fundación Jiménez Díaz University Hospital (J.F.F., B.I.), and Universidad Autonóma de Madrid (J.F.F.), Madrid, the Department of Cardiology, Hospital Universitario Salamanca, Salamanca (P.L.S.), Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (F.M.O.), Servicio de Cardiología, Hospital Universitario A Coruña, Instituto de Investigación ...
Charles University (CZ)
University of Wrocław (PL)
University of Liverpool (GB)
ORCID: Castellano, Jose M.
Pocock, Stuart J.
Bhatt, Deepak L.
Quesada, Antonio J.
Owen, Ruth
Sanchez, Pedro L.
Lozano, Iñigo
Roncaglioni, Maria C.
Baviera, Marta
Foresta, Andreana
Colivicchi, Furio
Doehner, Wolfram
Meyer, Antje
Schiele, François
Ecarnot, Fiona
Linhart, Aleš
Lubanda, Jean-Claude
Ponikowski, Piotr
Kasprzak, Marta
Collier, Timothy
Perel, Pablo
Proietti, Marco
Schoos, Mikkel M.
Simon, Tabassome
Beghi, Ettore
Vivas, David
Cordero, Alberto
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2022-09-15
Volume: 387
Issue: 11
Pages: 967-977
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2208275
OpenAlex: W4293176633
Cited by: 334
References: 28
Citations by year: 2026: 53 · 2025: 68 · 2024: 88 · 2023: 100 · 2022: 25
FWCI: 48.92
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Lirias (KU Leuven) (submittedVersion)
Funders: European Union Horizon (633765)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Keywords: polypill, secondary prevention of cardiovascular disease, myocardial infarction, aspirin, ramipril, atorvastatin, ACE inhibitors, statins, major adverse cardiovascular events, ischemic stroke, revascularization, medication adherence, combination therapy, secondary prevention after myocardial infarction, usual care comparison, cardiovascular mortality, urgent revascularization
MeSH terms: Atorvastatin, Ischemic Stroke, Angiotensin-Converting Enzyme Inhibitors, Aspirin, Cardiovascular Diseases, Humans, Myocardial Infarction, Platelet Aggregation Inhibitors, Ramipril, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Secondary Prevention

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