Polypill Strategy in Secondary Cardiovascular Prevention

Fecha de publicación: Fecha Ahead of Print:

Autores de ISABIAL

Participantes ajenos a ISABIAL

  • Castellano, JM
  • Pocock, SJ
  • Bhatt, DL
  • Quesada, AJ
  • Owen, R
  • Fernandez-Ortiz, A
  • Sanchez, PL
  • Ortuno, FM
  • Rodriguez, JMV
  • Domingo-Fernandez, A
  • Lozano, I
  • Roncaglioni, MC
  • Baviera, M
  • Foresta, A
  • Ojeda-Fernandez, L
  • Colivicchi, F
  • Di Fusco, SA
  • Doehner, W
  • Meyer, A
  • Schiele, F
  • Ecarnot, F
  • Linhart, A
  • Lubanda, JC
  • Barczi, G
  • Merkely, B
  • Ponikowski, P
  • Kasprzak, M
  • Alvira, JMF
  • Andres, V
  • Bueno, H
  • Collier, T
  • Van de Werf, F
  • Perel, P
  • Rodriguez-Manero, M
  • Garcia, AA
  • Proietti, M
  • Schoos, MM
  • Simon, T
  • Ferro, JF
  • Beghi, E
  • Bejot, Y
  • Vivas, D
  • Ibanez, B
  • Fuster, V
  • SECURE Investigators

Grupos de Investigación

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.

Copyright © 2022 Massachusetts Medical Society.

Datos de la publicación

ISSN/ISSNe:
0028-4793, 1533-4406

NEW ENGLAND JOURNAL OF MEDICINE  MASSACHUSETTS MEDICAL SOC

Tipo:
Article
Páginas:
967-977
PubMed:
36018037

Citas Recibidas en Web of Science: 138

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Financiación

Proyectos y Estudios Clínicos

Prevención Secundaria de la Enfermedad Cardiovascular en Ancianos (SECURE)

Investigador Principal: VICENTE IGNACIO ARRARTE ESTEBAN

633765 . 2018

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