The polypill reduced cardiovascular disease by approximately 20% compared with placebo in people considered at intermediate risk for heart disease, according to findings from the TIPS-3 study presented Nov. 13 during AHA 2020. Patients taking both a polypill plus aspirin saw even greater reductions.

Researchers, including Prem Pais, MD, MBBS, and Salim Yusuf, MD, BS, DPhil, FACC, randomized 5,713 patients (mean age 64 years; 47% male) from India, Colombia, Bangladesh, Canada, Malaysia, Indonesia, Tunisia, Tanzania and the Philippines to either: aspirin only (75 mg daily); polypill only; polypill plus aspirin (75 mg daily); or vitamin D (5,000 IU daily). Each intervention included a control group that received a matching placebo. The medications in the polypill were atenolol (100 mg), ramipril (10 mg), hydrochlorothiazide (25 mg), and simvastatin (40 mg).

Over a follow-up period of nearly five years, participants were monitored for the first occurrence of a major cardiovascular event, such as nonfatal heart attack, nonfatal stroke, heart failure, resuscitated cardiac arrest or cardiovascular death. Results found the polypill alone reduced cardiovascular disease by 21%; aspirin alone reduced cardiovascular death, heart attack and stroke by 14%; and the polypill plus aspirin reduce cardiovascular disease by 31%.

Based on these findings, “aspirin should be prescribed with a polypill in primary prevention for patients at intermediate risk of heart disease,” said Yusuf, who presented on the aspirin aspect of the study (TIPS + ASA), which was simultaneously published in the New England Journal of Medicine. “Our study results provide important data regarding the role of the polypill in preventing the development of heart disease.”

Pais, who presented on the broader aspects of the trial, said the findings add to the body of evidence suggesting the polypill is “a cost-effective strategy that could help meet global targets of reducing cardiovascular disease by 30% by 2030.” According to Yusuf, use of a polypill plus aspirin could prevent 3-5 million cardiovascular deaths globally and “future polypills, with newer statins, may reduce LDL cholesterol and blood pressure to a greater extent and could reduce cardiovascular disease risk greater than 50%.”

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention

Keywords: AHA Annual Scientific Sessions, AHA20, Primary Prevention, Secondary Prevention, Dyslipidemias, Aspirin

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