Five-drug polypill may slash heart disease risk

A polypill -- combining low doses of five drugs used to protect the heart -- is one step closer to reality.

"The thought that people might be able to take a single pill to reduce multiple cardiovascular risk factors has generated a lot of excitement," said Dr. Salim Yusuf, principal investigator and director of Population Health Research Institute at McMaster University and Hamilton Health Sciences in Ontario, Canada. "It could revolutionize heart disease prevention as we know it."

Marketed as Polycap, the new drug has 12.5 mg of thiazide, 50 mg of atenolol, 5 mg of ramipril, 20 mg of simvastatin and 100 mg of aspirin. According to a study presented March 30 by Dr. Yusuf at the American College of Cardiology meeting, patients age 45 to 80 with at least one cardiovascular risk factor saw reductions in blood pressure, LDL cholesterol and heart rate after taking the polypill for three months. The statin worked slightly better when taken singly, but the other drugs worked just as well in combination. The authors project this translates into a 27% relative risk reduction in cardiovascular disease and an 8% decrease in the chance of a stroke.

The full details of this large phase II randomized trial, which was funded by the drug manufacturer, Cadila Pharmaceuticals, were published in The Lancet the same day the findings were presented at the ACC meeting.

But questions remain. For instance, critics expressed concern about how to determine which drug is the trigger if a patient develops side effects. They also point out that the combination product cannot be titrated to individual patients. But an accompanying Lancet editorial stated what the polypill's proponents view as its ultimate upside -- that these results moved the world a notch closer to having a simpler way of reducing cardiovascular risk.

"This trial is a critical first step to inform the design of larger, more definitive studies, as well as further development of appropriate combinations of BP-lowering drugs with statins and aspirin," Dr. Yusuf said.