March 30, 2009 (Orlando, Fla.) -- It's cheap. It's easy. And in its first big test, it worked.
A "polypill" combining five heart drugs -- three blood-pressure-lowering drugs, a cholesterol-lowering statin drug, and aspirin -- is safe and works as well as any of the medications alone, researchers report.
The single capsule, taken just once a day, has the potential to slash the average person's risk of heart disease and stroke by about half, says study researcher Salim Yusuf, MD, of McMaster University in Hamilton, Ontario.
"Since each component of the polypill can reduce the risk of heart attack and stroke by 25%, [it's reasonable to expect that] you can get at least twice that improvement with five components," he tells WebMD.
The real advantage of the single daily pill "is its simplicity," says James Stein, MD, a heart specialist at University of Wisconsin in Madison. Stein was not involved with the work.
Research has shown that the more pills a person has to take, the less likely to he is swallow all his medication, he tells WebMD. And the more doses a person skips, the less likely high blood pressure and elevated cholesterol will be brought under control.
"It should improve compliance," Stein says.
Also, the drug will be inexpensive, as all five of its components are available in generic form, Stein says.
Polypill Lowers Blood Pressure, Cholesterol
The pill contains low doses of three blood-pressure-lowering drugs from different classes -- the beta-blocker atenolol, the ACE inhibitor ramipril, and the diuretic hydrocholorothiazide -- plus the statin simvastatin and a 100-milligram dose of aspirin.
Participants were randomly assigned either to a group given the polypill or to one of eight groups given individual components of the pill or combinations of them. The participants took their assigned drugs for three months.
The study was funded by Cadila Pharmaceuticals of India, which makes Polycap. The findings were presented at the annual meeting of the American College of Cardiology and published online by The Lancet.
Compared to groups not receiving blood-pressure-lowering drugs, the polypill reduced systolic blood pressure by 7.4 points and diastolic blood pressure by 5.6 points. This was similar to results when three blood-pressure-lowering drugs were used, with or without aspirin.
LDL "bad" cholesterol dropped by 25% in the polypill group and by 28% in the group that took the statin drug separately. The reduction in heart rate and blood clotting in the polypill group was similar to that seen with the beta-blocker or aspirin alone.
The side effect rate "was identical for the polypill as for the five separate drugs. This was a pleasant surprise," Yusuf says.
The next step: a study of 5,000 people with one risk factor for heart disease to confirm the results.
Not everyone is as enthusiastic as Yusuf.
"We need a mass approach to heart disease prevention, but not necessarily with pills," says Daniel Jones, MD, past president of the American Heart Association (AHA) and dean of the University of Mississippi School of Medicine.
"[You might be able] to achieve the same results with a lifestyle approach that stresses diet and exercise," he tells WebMD.
Also, "a combination tablet may not be all things to all people," says AHA spokesman Clyde Yancy, MD, medical director of the Baylor Heart and Vascular Institute at Baylor University Medical Center in Dallas.
He says testing of different risk groups, different age groups, and different ethnic groups is needed.