Abstract
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.
Highlights
Introduction and rationale of theTIPS-3With 80% of cardiovascular disease (CVD) cases occurring in low- and middle-income countries (LICs and MICs), there is a growing need to implement CVDStudies comparing the effects of a fixed dose combination (FDC) pill on risk factor levels have shown that significant reductions in blood pressure and cholesterol levels can be achieved, with better adherence compared to usual care.[1]
Studies comparing the effects of a FDC pill on risk factor levels have shown that significant reductions in blood pressure and cholesterol levels can be achieved, with better adherence compared to usual care.[1]
This study aims to determine whether the Polycap reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk
Summary
Introduction and rationale of theTIPS-3With 80% of cardiovascular disease (CVD) cases occurring in low- and middle-income countries (LICs and MICs), there is a growing need to implement CVDStudies comparing the effects of a FDC pill (usually containing two or three blood pressure agents and a statin) on risk factor levels have shown that significant reductions in blood pressure and cholesterol levels can be achieved, with better adherence compared to usual care.[1]. Studies that directly examine clinical outcomes with a FDC pill are lacking, and even a meta-analysis of existing trials had too few events to provide a reliable estimate of the benefits of a polypill on CVD.[2] The Heart Outcomes Prevention Evaluation (HOPE)-3 placebo-controlled randomized controlled trial (RCT) tested a “strategy” of FDC blood pressure and cholesterol lowering therapy with. Joseph et al 73 candesartan plus hydrochlorothiazide (16/12.5 mg/day) in addition to rosuvastatin (10 mg/day) (as separate agents), and observed that their combination reduced major cardiovascular events by 29% in persons at intermediate risk for developing CVD, with a 40% relative risk reduction (RRR) in those with elevated blood pressure.[3,4] Even larger reductions in CVD risk may be achievable with more intensive regimens, but data are needed that directly examine the clinical benefits and tolerance of such a strategy using a single FDC pill, which is the focus of this study. The impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial
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