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, SECURE Investigators
Аннотация
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.).