Polypill plus aspirin and polypill alone reduced cardiovascular disease risk

A single, daily pill combining blood pressure and cholesterol medications, along with the addition of a daily dose of aspirin, reduced cardiovascular disease events in people at risk for heart disease, according to late-breaking research presented today in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2020. The virtual conference, held Friday, November 13 - Tuesday, November 17, 2020, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide. The manuscript of this study is simultaneously published today in The New England Journal of Medicine.

The medicine tested in this study is a fixed-dose combination therapy (or a "polypill") combining blood pressure and cholesterol lowering medications. Researchers assessed the polypill's effects on cardiovascular disease events - such as heart attack, stroke and cardiovascular death - when given alone or with aspirin, in patients considered at intermediate risk of cardiovascular disease. They also examined the effects of aspirin alone.

The International Polycap Study (TIPS)-3 is a large, randomized, placebo-controlled trial conducted in nine countries. The study included 5,700 people considered at intermediate risk of developing heart disease. The average age of the participants was 64 years, and 47% were male.

Participants were randomly assigned to different interventions: 1) 75 mg daily of aspirin; 2) a polypill combining blood pressure and cholesterol medication daily; 3) polypill and 75 mg aspirin daily; or 4) vitamin D 5,000 IU daily. Each intervention included a control group who received a matching placebo. The medications in the polypill were atenolol 100mg, ramipril 10mg, hydrochlorothiazide 25 mg, and simvastatin 40 mg.

Over the follow-up period of nearly five years, participants were monitored for the first occurrence of a major cardiovascular event, such as non-fatal heart attack, non-fatal stroke, heart failure, resuscitated cardiac arrest or cardiovascular death.

The analysis of all patient groups found:

• the polypill alone reduced cardiovascular disease by 21%;
• aspirin alone reduced cardiovascular death, heart attack or stroke by 14%;
• and the polypill plus aspirin reduced cardiovascular disease by 31%.

Aspirin should be prescribed with a polypill in primary prevention for patients at intermediate risk of heart disease. Our study results provide important data regarding the role of the polypill in preventing the development of heart disease."

Salim Yusuf, M.D., B.S., D. Phil., co-author of the study and professor of medicine at McMaster University School of Medicine in Toronto, Canada

Co-author Prem Pais, M.B.B.S., M.D., a professor in the division of clinical research and training at St. John's Research Institute in Bangalore, India, added, "We were also interested in evaluating if combining blood pressure and cholesterol reduction medications in a single pill would be effective for this population. This is a cost-effective strategy that could help meet global targets of reducing CVD by 30% by 2030."

"Use of a polypill plus aspirin can avert 3 - 5 million cardiovascular deaths globally," said Yusuf. "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%."