Once-a-day Heart Combo Pill Shows Guarantee In Study
The experimental combo pill was as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a persons risk of heart disease and stroke roughly in half, the study concludes.
The approach needs far more testing – as well as approval from the Food and Drug Administration, something that could take years – but it could make heart disease prevention much more common and more effective, doctors say.
“Widely applied, this could have profound implications,” said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke Universitys heart research institute. “President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that.”
The polypill also 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, he said.
No price for the polypill has been disclosed, but its generic components cost only a total of $17 a month now and doctors expect the combo would sell for far less.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. Johns Medical College in Bangalore, India. The findings were presented Monday at the cardiology colleges conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated 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).
Doctors have talked about such a possibility for years. As the patents on many heart medicines expired and the drugs became available as cheap generics, a few companies started trying to develop all-in-one pills.
Formulating a single pill of five drugs that work in five different ways is a complex task – more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended.
The Polycap is the furthest along, and this is the largest study of one so far.
The study involved 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.
Compared to groups given no blood pressure medicines, those who got the polypill lowered their systolic blood pressure (the top number) by more than 7 units and their diastolic (the bottom number) by about 6 – comparable to levels for people who were given the three drugs without aspirin and the cholesterol drug.
These drops were modest, probably because doses were low and most participants had only moderately high blood pressure to start with, Yusuf said.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent 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 with the polypill as with aspirin alone.
Side effect rates were the same for the polypill as for the five medicines individually.