A single daily pill that combines aspirin and four blood pressure and cholesterol medicines has passed its first big test, potentially offering a cheap, simple way to prevent both heart disease and stroke.
The experimental “polypill” proved as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person's risk of heart disease and stroke in half, the study concludes.
“Widely applied, this could have profound implications,” said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke University's heart research institute.
The polypill has big psychological advantages, said Dr.James Stein of the University of Wisconsin-Madison. “If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden,” and respond by skipping doses.
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The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College, Bangalore, India. Results were presented Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the “water pill” thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Participants were about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease – high blood pressure, high cholesterol, obesity, diabetes or smoking. Four hundred got the polypill. The rest were put in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.
Compared with groups given no blood pressure medicines, the polypill lowered systolic blood pressure (the top number) by more than seven units and diastolic (bottom number) by about six – comparable to levels for people given the three drugs without aspirin and the cholesterol drug.
LDL, or bad cholesterol, dropped 23 percent on the poly pill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same as with aspirin alone.
Side effect rates also were the same for the polypill as for the five separate medicines.
Polycap's maker sponsored the study, and Yusuf has been a paid speaker for several makers of heart drugs. No price for the poly pill is available, but its generic components cost $17 a month, Cannon said.
A bigger study is needed to see whether the polypill actually cuts heart attacks and strokes, he wrote in a commentary in Lancet.
A polypill also would need Food and Drug Administration approval.