Once-a-day heart combo pill shows promise

From msnbc.com:

It’s been a dream for a decade: a single daily pill combining aspirin, cholesterol medicine and blood pressure drugs — everything people need to prevent heart attacks and strokes in a cheap, generic form.

Skeptics said five medicines rolled into a single pill would mean five times more side effects. Some people would get drugs they don’t need, while others would get too little. One-size-fits-all would turn out to fit very few, they warned.

Now the first big test of the “polypill” has proved them wrong.

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 person’s 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.

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. John’s Medical College in Bangalore, India. The findings 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 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).

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.

Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.

Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.

A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.

A polypill also would need FDA approval, even though all of its components have long been sold separately. And establishing the proper doses could become a regulatory nightmare, Cannon warned.

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