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Polypill with or without Aspirin in Persons without Cardiovascular Disease


The background

A polypil containing statins, several blood pressure-lowering drugs, and aspirin have been proposed to reduce the risk of heart disease.


Using a 2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART risk score to receive a polypill (including 40 mg simvastatin, 100 mg atenolitol, 25 mg hydrochlorothiazide and 25 mg were included) 10 mg ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the results for polypil alone compared with the matching location, compared to the matched placebo for aspirin alone, and double placebo for polypil plus aspirin. For polypil-alone and polypil-plus-aspirin comparisons, the primary outcome was cardiac causes, death from myocardial infarction, stroke, resuscitation cardiac arrest, heart failure, or resurgence. For the aspirin comparison, the primary outcome was death from cardiac causes, myocardial infarction, or stroke. Security was also assessed.


A total of 5713 participants randomized, and the average follow-up was 4.6 years. Low-density lipoprotein cholesterol levels were approximately 19 mg per dl and lower systolic blood pressure, which was approximately 5.8 mm Hg with polypil and lower than combination therapy with placebo. The primary outcome for polypil comparisons occurred in 126 participants (4.4%) in the polypil 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 aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypil-plus-aspirin comparison occurred in the combined-treatment group in 59 participants (4.1%) and in the double-placebo group in 83 (5.8%) (hazard ratio, 0.69; CI; 0.50 to 0.97). . The incidence of hypotension or dizziness was higher in the groups that received polypill compared to their respective placebo groups.

The conclusion

Combined treatment with a polypil plus aspirin resulted in a lower incidence of cardiac events than placebo among participants without heart disease who were at intermediate heart risk. (Funded by the Wellcome Trust and others; TIPS-3 clinicaltrails.gio number) NCT01646437.)

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