"Polypill" Shows Promise for Heart Patients

A combination pill containing 4 different drugs may benefit patients who are at high risk for cardiovascular disease.

At the heart of every cardiovascular patient’s treatment regimen is a daily cocktail of medications designed to keep blood pressure and cholesterol in check. Combining them into a single, affordable, fixed-dose combination pill is a concept experts have debated for years—and a new, placebo-controlled international trial suggests that a “polypill” could significantly cut patients’ risk of heart disease and stroke.

Researchers in the Pill Collaborative Group found that patients with raised heart risk who took a pill containing 75 mg of aspirin, 10 mg of lisinopril, 12.5 mg of hydrochlorothiazide, and 20 mg of simvastatin for 12 weeks showed substantial reductions in systolic blood pressure and low-density lipoprotein, or “bad” cholesterol. These benefits amount to an estimated 50% reduction in cardiovascular risk—slightly lower than the 80% predicted by previous research.

The polypill did have its drawbacks, however. Of the study’s 378 participants, about 1 in 6 patients experienced side effects with the pill. Approximately 1 in 20 patients stopped taking the combination drug as a result of these side effects, which included many of the well-known effects of aspirin, such as bleeding and gastric irritation, and blood pressure lowering angiotensin-converting enzyme inhibitors, such as cough and dizziness.

“The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher,” study authors reported in the May 26, 2011, online issue of the open access journal PLoS One. Lead investigator Anushka Patel, MD, MS, PhD, said the results were enlightening because “previous studies could not measure polypill side effects reliably, which is really important.”

Dr. Patel, an associate professor with the Sydney Medical School at the University of Sydney, said that although it did show that previous studies had “considerably underestimated” the polypill’s side effects, the trial was “reassuring in that we did not see unexpected problems." Because of the additional side effects, she and colleagues say the pill should be reserved for those with a high risk of cardiovascular disease.

The polypill used in the study was provided by Dr. Reddy’s Laboratories and lauded for its cost-effectiveness. According to a news release on the trial, the pill would cost only a few dollars a month in developing countries. Study coauthor Otavio Berwanger, MD, PhD, of the Hospital do Coração in Sao Paolo, Brazil, said this research “heralds a more balanced, measured approach than the initial hype around the polypill.”

He added this caveat: “It is not a panacea. It is a really promising part of an overall package that should include measures to tackle the major causes of heart disease and cancer, such as smoking, poor diet, and physical inactivity.”

For other articles in this issue, see:

• Errors Lurk in Switch to e-Prescribing
• 3 Steps to Better Medication Management