Polypill Strategy in Secondary Cardiovascular Prevention

作者：Jose Maria Castellano, Stuart Pocock, Deepak L. Bhatt, Antonio J. Quesada, Ruth Owen, Antonio Fernández‐Ortíz, Pedro Luis Sanchez, Francisco R. Marín, José Manuel Vázquez‐Rodríguez, Alexandra Domingo-Fernández, Íñigo Lozano, Maria Carla Roncaglioni, Marta Baviera, Andreana Foresta, Maria Luisa Ojeda Fernandez, Furio Colivicchi, Stefania Angela Di Fusco, Wolfram Doehner, Antje Meyer, François Schiele, Fiona Ecarnot, Aleš Linhart, Jean-Claude Lubanda, György Bárczi, Béla Merkely, Piotr P. Ponikowski, Marta Kasprzak, Juan Miguel Fernández-Alvira, Vicente Andrés, Héctor Bueno, Timothy J. Collier, Frans Van de Werf, Pablo Perel, Moisés Rodríguez‐Mañero, Angeles Alonso Garcia, Marco Proietti, Mikkel Malby Schoos, Tabassome Simon, Jose Carlos Fernandez-Ferro, Nicolas Gabriel Lopez, Ettore Beghi, Yannick Béjot, David Vivas, Alberto Cordero, Borja Ibáñez, Valentı́n Fuster · 发表于：New England Journal of Medicine · 年份：2022 · DOI：10.1056/nejmoa2208275 · 被引用次数：327 · 研究领域：Medication Adherence and Compliance、Heart Failure Treatment and Management、Diabetes Treatment and Management

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 i...