Polypill with or without aspirin in persons without cardiovascular disease

Yusof, Salim and Joseph, Philip and Dans, Antonio and Gao, Peggy and Koon, Teo and Xavier, Denis and López-Jaramillo, Patricio and Yusoff, Khalid and Santoso, Anwar and Gamra, Habib and Talukder, Shamim and Christou, Courtney and Girish, Preeti and Yeates, Karen and Xavier, Freeda and Dagenais, Gilles and Rocha, Catalina and McCready, Tara and Tyrwhitt, Jessica and Bosch, Jackie and Pais, Prem and Abdullah, Fa’iza and Halim, Noor Azlina and Sulong, Robiatu Adawiah and Latfi, Nur Farhana and Jamani, Nurjasmine Aida and Md Aris, Mohd Aznan and Draman, Samsul (2020) Polypill with or without aspirin in persons without cardiovascular disease. The New England Journal of Medicine. pp. 1-5. ISSN 0028-4793

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Abstract

BACKGROUND A polypill comprising statins, multiple blood-pressure–lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease. METHODS Using 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. RESULTS A 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 doubleplacebo group (hazard ratio, 0.69; 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. CONCLUSIONS Combined 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.)

Item Type:	Article (Case Report)
Additional Information:	5838/84897
Uncontrolled Keywords:	Polypill, aspirin in persons, cardiovascular disease
Subjects:	R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine R Medicine > RM Therapeutics. Pharmacology R Medicine > RS Pharmacy and materia medica R Medicine > RV Botanic, Thomsonian, and eclectic medicine
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Medicine > Department of Family Medicine (Effective: 1st January 2011)
Depositing User:	SR NUR FARHANA LATFI
Date Deposited:	26 Nov 2020 13:47
Last Modified:	16 Mar 2022 16:04
URI:	http://irep.iium.edu.my/id/eprint/84897

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