A Polypill for Primary Prevention of Cardiovascular Disease in Intermediate Risk People: Results of the International Polycap Study (TIPS)-3
Author Block: Prem Pais, St. John's Res Inst, Bangalore, India; Salim Yusuf, Population Health Res Inst, Hamilton, ON, Canada; TIPS-3 Investigators
Disclosure Block: P. Pais: Other; Modest; Cadila Phrmaceuticals Ltd. S. Yusuf: Research Grant; Significant; Bayer Pharmaceuticals. Honoraria; Modest; Bayer Pharmaceuticals. Research Grant; Significant; AstraZeneca. Honoraria; Modest; AstraZeneca. Research Grant; Significant; Boehringer-Ingelheim. Honoraria; Modest; Boehringer-Ingelheim. Research Grant; Significant; Cadila Pharmaceuticals, Sanofi. Honoraria; Modest; Sanofi. Research Grant; Significant; Bristol Myers Squibb. Honoraria; Modest; Bristol Myers Squibb.
Background: It has been suggested that fixed dose combination therapy (or a polypill) combining blood pressure lowering medications with a statin, and with or with aspirin, could provide substantial reductions in cardiovascular events in primary prevention. We evaluated a polypill in a large, placebo-controlled randomized controlled trial.
Hypothesis: Combined blood pressure and cholesterol reduction with a polypill will reduce adverse cardiovascular events in a primary prevention population at intermediate risk for developing cardiovascular disease (CVD)
Methods: The International Polycap Study (TIPS)-3 is a 2x2x2 factorial randomized controlled trial conducted in 9 countries in an intermediate CVD risk primary prevention population. Participants were randomly assigned to 1) Polycap (comprised of atenolol 100 mg/daily, ramipril 10 mg/daily, hydrochlorothiazide 25 mg/daily, and simvastatin 40 mg/daily in a single pill) versus matching placebo, 2) aspirin 75 mg daily versus placebo, and 3) Vitamin D 60,000 IU monthly versus placebo. This analysis will report the results of Polycap versus matching placebo. The primary outcome was first occurrence of the composite of CV death, non-fatal myocardial infarction, non-fatal stroke, heart failure, resuscitated cardiac arrest or arterial revascularization.
Results: 5713 participants were randomized, and mean follow up was 4.6 years. Mean age of the population at baseline was 63.9 years, and 47% were male. Mean INTERHEART risk score (16.8) was consistent with an intermediate risk, primary CVD prevention population. Results on changes in risk factors, clinical outcomes and safety will be presented.
Conclusions: This study will provide important data regarding the role of the polypill in primary CVD prevention.