ORLANDO -- A once-a-day polypill that combines aspirin, blood-pressure and cholesterol drugs sharply reduces the risk of heart attack and stroke, potentially offering an inexpensive way to save millions of lives, researchers reported Monday.
The experimental five-drug combination proved about as safe and effective as each drug given alone. It cut a patient's risk of heart attack by 62% and stroke by 48%.
"Sometimes the biggest scientific achievements are the simplest," says James Stein of the University of Wisconsin. "It's a pill for the masses."
The pill was the brainchild of study leader Salim Yusuf of McMaster University in Hamilton, Ont., and a few other experts intent on halting a heart-disease epidemic that claims 18 million lives each year, most of them in countries with little access to health care. It also may offer patients in the developed world a way to simplify care and assure that more people take their medicine, Stein says.
Robert Bonow of Northwestern University says the pill may have a downside by leading people to think it's a cure for unhealthy living: "It may not be the best thing for us."
The study, led by Yusuf and Prem Pais of St. John's Medical College in Bangalore, involved more than 2,000 people with one heart disease risk factor at 50 medical centers in India. Results were released at an American College of Cardiology meeting and online by the journal Lancet. The pill was made by India-based Cadila Pharmaceuticals, which funded the study.
Those in the trial were assigned to nine groups of about 200 people each. One group took the polypill, which contained the three blood pressure drugs atenolol, ramipril and thiazide; the generic cholesterol drug simvastatin and a baby aspirin. The rest of the groups were placed on individual medicines. The trial lasted 12 weeks.
Patients who took the polypill saw their systolic blood pressure (the top number) drop by about 7 millimeters of mercury and the diastolic pressure (the bottom number) drop by 6, on par with people given blood pressure drugs alone. Bad cholesterol dropped by 23%, vs. 28% in people who took simvastatin alone.
Yusuf says other studies are planned. One will use a stronger version of the pill in heart patients; another large-scale study will focus on people with moderate heart risk.
The study didn't show whether the drug would prevent heart attacks and strokes as well as treatments tailored to meet individual needs, says Robert Califf of Duke University. "This is exactly the opposite of personalized medicine," Califf says. "Both approaches need to play out. Let's see who wins."
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