Polypill Cuts Cardiovascular Risk in Half with No
Additional Side Affects
Magic pill contains three blood pressure lowering
drugs, a statin and aspirin
March 30, 2009 – Senior citizens and other healthy
individuals may be able to cut their risk of cardiovascular disease by
50 to 60 percent by taking a single pill, called the “polypill,” that
combines three blood pressure (BP) lowering drugs at low doses, a
statin, and aspirin, according to research presented today at the
American College of Cardiology’s 58th annual scientific session.
The Indian Polycap Study (TIPS) - the first to
evaluate the tolerability of the polypill and test whether it leads to
meaningful changes in cardiovascular risk factors - enrolled 2,053
participants. During the three-month study, researchers compared the
impact of the polypill and eight other pharmacologic therapies on BP,
blood cholesterol levels and heart rate, among other measures.
The combination pill (PolycapTM), which includes
low doses of thiazide (12.5 mg/day), atenolol (50 mg/day), ramipril (5
mg/day), simvastatin (20 mg/day) and aspirin (100 mg/day), significantly
reduces LDL cholesterol, BP and platelet aggregability.
Simvastatin is also marketed as Zocor.
“The thought that people might be able to take a
single pill to reduce multiple cardiovascular risk factors has generated
a lot of excitement; it could revolutionize heart disease prevention as
we know it,” said Salim Yusuf, DPhil, FRCPC, of the Population Health
Research Institute at McMaster University and Hamilton Health Sciences,
Hamilton, ON, Canada, and co-chair and principal investigator of the
study.
“Before this study, there were no data about
whether it was even possible to put five active ingredients into a
single pill, in terms of feasibility, the bioavailability of different
agents and possible interactions, and we found that it works. And side
effects with the polypill were no different than when taking one or two
medications.”
Participants were randomized to the Polycap (400
people) group or to one of eight other study arms, each with about 200
individuals, which included aspirin alone, simvastatin alone,
hydrochlorthiazide alone, three combinations of the two BP lowering
drugs, three BP lowering drugs alone, and an arm with three BP lowering
drugs plus aspirin.
Patients were recruited from 50 centers in India
between March 5, 2007 and August 5, 2008. The mean age of the
participants was 54 years, one-third had diabetes, mean baseline BP was
134/85 mmHg, mean cholesterol was 180 mg/dl, HDL 44 mg/dl, and LDL 117
mg/dl.
There were several exclusion criteria. The polycap
was well tolerated and there was no evidence of problems with increasing
number of active components in the pill.
“The side effects of one drug may be counteracted
by beneficial effects of another, so the rate of stopping medications
was the same,” Yusuf said.
Compared to groups not receiving BP lowering
agents, the polycap reduced systolic BP by 7.4 mmHg and diastolic BP by
5.6 mmHg; this was similar to when 3 BP lowering drugs were used, with
or without aspirin.
BP reductions increased with the number of BP
lowering drugs used (2.2/1.3 mmHg with one drug, 4.7/3.6 with two drugs,
and 6.3/4.5 with three drugs).
While the effects of the polypill on BP were lower
than what was projected by previous investigators, who expected a 20/11
mmHg reduction, this is likely because most participants in the present
study were not hypertensive.
Still, BP reductions among this group could
theoretically lead to about a 24 percent risk reduction in CHD and 33
percent risk reduction in strokes in those with average BP levels,
according to Dr. Yusuf.
Polycap reduced LDL by 0.70 mmol/L, which was
slightly less than that with simvastatin used alone (0.83 mmol/L;
p<0.04); both of which were greater than groups without simvastatin
(p<0.001).
The reductions in heart rate with polycap (7.0
beats/min) and other arms using atenolol (7.0 beats/min) were similar;
and both were significantly greater than that in arms without atenolol
(p<0.001).
“This trial is a critical first step to inform the
design of larger, more definitive studies, as well as further
development of appropriate combinations of BP lowering drugs with
statins and aspirin,” said Yusuf, who led the study jointly with Prem
Pais, M.D. at St. John’s Medical College, Bangalore, India.
Complete study findings are being published
simultaneously in The Lancet.
Information sources:
The study was sponsored by Cadila
Pharmaceuticals, India, which played no role in data collection,
analysis or interpretation. Dr. Yusuf will present the study, “Impact of
Combinations of Three Blood Pressure Lowering Drugs, a Statin and
Aspirin on Cardiovascular Risk Factors in 2,000 Individuals Without
Cardiovascular Disease,” on Monday, March 30 at 2:00 p.m. ET in Hall A2.
The American College of Cardiology (www.acc.org)
works to influence health care policy and represents the majority of
board certified cardiovascular care specialists through education,
research, promotion, and the development and application of standards
and guidelines. ACC.09 is the largest cardiovascular meeting, bringing
together cardiologists and cardiovascular specialists to share the
newest discoveries in treatment and prevention, while helping the ACC
achieve its mission to address and improve issues in cardiovascular
medicine.
ACC.09 is the premier cardiovascular medical
meeting, connecting cardiologists and cardiovascular specialists to the
latest and most innovative findings in cardiovascular science.
Keep up with the latest news for senior citizens, baby
boomers
March 30, 2009 – Senior citizens and other healthy
individuals may be able to cut their risk of cardiovascular disease by
50 to 60 percent by taking a single pill, called the “polypill,” that
combines three blood pressure (BP) lowering drugs at low doses, a
statin, and aspirin, according to research presented today at the
American College of Cardiology’s 58th annual scientific session. 