TY - JOUR

T1 - Polypill Strategy in Secondary Cardiovascular Prevention

AU - Castellano, Jose M.

AU - Pocock, Stuart J.

AU - Bhatt, Deepak L.

AU - Quesada, Antonio J.

AU - Owen, Ruth

AU - Fernandez-Ortiz, Antonio

AU - Sanchez, Pedro L.

AU - Ortuño, Francisco Marin

AU - Vazquez Rodriguez, Jose M.

AU - Domingo-Fernández, Alexandra

AU - Lozano, Iñigo

AU - Roncaglioni, Maria C.

AU - Baviera, Marta

AU - Foresta, Andreana

AU - Ojeda-Fernandez, Luisa

AU - Colivicchi, Furio

AU - Di Fusco, Stefania A.

AU - Doehner, Wolfram

AU - Meyer, Antje

AU - Schiele, François

AU - Ecarnot, Fiona

AU - Linhart, Aleš

AU - Lubanda, Jean Claude

AU - Barczi, Gyorgy

AU - Merkely, Bela

AU - Ponikowski, Piotr

AU - Kasprzak, Marta

AU - Fernandez Alvira, Juan M.

AU - Andres, Vicente

AU - Bueno, Hector

AU - Collier, Timothy

AU - Van de Werf, Frans

AU - Perel, Pablo

AU - Rodriguez-Manero, Moises

AU - Garcia, Angeles Alonso

AU - Proietti, Marco

AU - Schoos, Mikkel M.

AU - Simon, Tabassome

AU - Ferro, Jose Fernandez

AU - Lopez, Nicolas

AU - Beghi, Ettore

AU - Bejot, Yannick

AU - Vivas, David

AU - Cordero, Alberto

AU - Ibañez, Borja

AU - Fuster, Valentin

N1 - Publisher Copyright: Copyright © 2022 Massachusetts Medical Society.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

U2 - 10.1056/NEJMoa2208275

DO - 10.1056/NEJMoa2208275

M3 - Journal article

C2 - 36018037

AN - SCOPUS:85138446556

VL - 387

SP - 967

EP - 977

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 11

ER -