• Philip Joseph, Prem Pais, Antonio L Dans, Jackie Bosch, Denis Xavier, Patricio Lopez-Jaramillo, Khalid Yusoff, Anwar Santoso, Shamim Talukder, Habib Gamra, Karen Yeates, Paul Camacho Lopez, Jessica Tyrwhitt, Peggy Gao, Koon Teo, Salim Yusuf, and TIPS-3 Investigators.
• Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.
• Am. Heart J. 2018 Dec 1; 206: 72-79.

BackgroundIt is hypothesized that in individuals without clinical cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction in CVD risk could be achieved using fixed dose combination (FDC) therapy (usually comprised of multiple blood-pressure agents and a statin [with or without aspirin]) in a single "polypill". However, the impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial.MethodsTIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events.ResultsThe study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk.ConclusionResults of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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