Combo pill alone and with aspirin lowers heart disease risk

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," said Salim Yusuf, M.D., B.S., D. Phil., a co-author of the study and professor of medicine at McMaster University School of Medicine in Toronto, Canada. "Our study results provide important data regarding the role of the polypill in preventing the development of heart disease."

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%."