Hamilton, Ontario—Simply combining common preventive medications into a polypill can reduce cardiovascular incidents by as much as 40%, according to a new international study.

In a report in the New England Journal of Medicine, use of the polypill, which combines three blood-pressure medications and a lipid-lowering medication taken alone or with aspirin, lowered the risk of heart attack, stroke, revascularization procedures or other cardiovascular incidents by about 20%. Canadian researchers from McMaster University and colleagues suggest that adding aspirin could increase the protective effect to 40%.

“This is the start of a transformational approach to preventing heart disease. We could save millions of people from experiencing serious heart disease or stroke each year with effective use of the polypill and aspirin,” explained Salim Yusuf, MD, DPhil, coprincipal investigator for the study and a professor of medicine at McMaster University in Canada.

Over a mean follow-up of 4.6 years, 5,713 participants without cardiovascular disease who had an elevated INTERHEART Risk Score underwent randomization 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.

Defined as the primary outcomes for the polypill-alone and polypill-plus-aspirin comparisons were 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, according to the researchers, who add that safety was also assessed.

Results indicate that 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 compared with placebo.

The study team advises that 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% CI, 0.63-1.00). In addition, 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, 0.67-1.10).

Meanwhile, 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 double-placebo group (hazard ratio, 0.69; CI, 0.50-0.97).

Groups receiving the polypill reported higher incidence of hypotension or dizziness compared with placebo, the study notes.

“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,” the authors conclude.

“A polypill is not only effective, it is likely to be cost effective since it is based on using commonly used generic drugs,” said Prem Pais, MBBS, MD, of St. John's Medical College and Research Institute in Bangalore, India, coprincipal investigator of the study. “A polypill is convenient for patients to use as it combines several effective drugs in a single pill and is taken once a day, which would be expected to improve adherence.”

The study was conducted in 89 centers from nine countries and coordinated globally by the Population Health Research Institute (PHRI), a joint institute of McMaster University and Hamilton Health Sciences.

“The use of the polypill widely will benefit people in both the rich and poor countries as there are major gaps in treatments in populations all over the world,” pointed out coauthor Philip Joseph, MD associate professor of medicine at McMaster and cardiologist with Hamilton Health Sciences.

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