• Salim Yusuf, Philip Joseph, Antonio Dans, Peggy Gao, Koon Teo, Denis Xavier, Patricio López-Jaramillo, Khalid Yusoff, Anwar Santoso, Habib Gamra, Shamim Talukder, Courtney Christou, Preeti Girish, Karen Yeates, Freeda Xavier, Gilles Dagenais, Catalina Rocha, Tara McCready, Jessica Tyrwhitt, Jackie Bosch, Prem Pais, and International Polycap Study 3 Investigators.
• From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.Y., P.J., P. Gao, K.T., C.C., T.M., J.T., J.B.), Queen's University, Kingston, ON (K. Yeates), and Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.D.) - all in Canada; the University of the Philippines, Manila (A.D.); St. John's Medical College, Bangalore, India (D.X., P. Girish, F.X., P.P.); Fundación Oftalmológica de Santander, Universidad de Santander, Bucaramanga, Colombia (P.L.-J., C.R.); Universiti Teknologi MARA Selayang, Selangor, and UCSI University, Cheras, Kuala Lumpur - both in Malaysia (K. Yusoff); Universitas Indonesia, National Cardiovascular Center, Jakarta (A.S.); Fattouma Bourguiba Hospital and University of Monastir, Monastir, Tunisia (H.G.); and Eminence, Dhaka, Bangladesh (S.T.).
• N. Engl. J. Med. 2021 Jan 21; 384 (3): 216-228.

BackgroundA polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease.MethodsUsing a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed.ResultsA total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.ConclusionsCombined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).Copyright © 2020 Massachusetts Medical Society.

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