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Once-a-day heart combo pill shows promise in study

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“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>”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. “President Obama is trying to offer the greatest care to

the greatest number. This very much fits in with

that.”

“font-family: Verdana”>The polypill also has big psychological

advantages, said Dr. James Stein of the University of

Wisconsin-Madison.

“font-family: Verdana”>”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.

“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>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).

“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>The Polycap is the furthest along, and this

is the largest study of one so far.

“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>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.

“font-family: Verdana”>These drops were modest, probably because

doses were low and most participants had only moderately high blood

pressure to start with, Yusuf said.

“font-family: Verdana”>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.

“font-family: Verdana”>Anti-clotting effects seemed the same with

the polypill as with aspirin alone.

“font-family: Verdana”>Side effect rates were the same for the

polypill as for the five medicines

individually.

“font-family: Verdana”>”That was a big surprise. I would have

expected five times the number of people to have side effects,”

because of the possibility the drugs would interact and magnify any

problems, said Dr. Christopher Cannon, a cardiologist at

Harvard-affiliated Brigham and Women’s Hospital in Boston who had

no role in the study.

“font-family: Verdana”>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.

“font-family: Verdana”>Polycap’s maker sponsored the study, and

Yusuf has been a paid speaker for several makers of heart

drugs.

“font-family: Verdana”>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.

“font-family: Verdana”>”It’s a first step. I would caution against

jumping to the conclusion this is the magic solution to our

prevention problems,” said Dr. Raymond Gibbons of the Mayo Clinic,

a former American Heart Association president.

“font-family: Verdana”>Studies show that healthy diets and exercise

give better protection than pills, and too many people already

think “that because they’re on a statin, they can go to

McDonald’s,” Gibbons said.

“font-family: Verdana”>A big issue is who should get the polypill.

The study tested it in people with risk factors that would already

qualify them for treatment.

“font-family: Verdana”>”Should high-risk people who do not yet have

heart disease take it? My guess is, that’s where the field will go

to rapidly,” Yusuf said.

“font-family: Verdana”>Conversely, people with established heart

disease may need more medicines than the modest amounts in this

all-in-one pill.

“font-family: Verdana”>”It won’t be for everybody,” Cannon said.

Some people would be overtreated by getting medicines for

conditions they don’t yet have, such as high cholesterol. Others

may be undertreated by too-low doses in the combo pill. Several

polypills of different strengths may be needed, he

said.

“font-family: Verdana”>”We have to be cautious about assuming that

one size fits all,” Stein said. “Treating risk factors is a lot

like cooking — the ingredients count.”

“font-family: Verdana”>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.

“font-family: Verdana”>___

“font-family: Verdana”>On the Net:

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