“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:
“font-family: Verdana”>Cardiology meeting:
“http://www.acc.org/”>
“font-family: Verdana”>http://www.acc.org
“font-family: Verdana”>Medical journal:
“http://www.lancet.com/”>
“font-size: small”>http://www.lancet.com
