5 In 1 Polypill May Significantly Cut Heart Risk In Healthy People

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Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Hypertension;  Cholesterol
Article Date: 31 Mar 2009 - 0:00 PDT

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A study conducted in India suggested taking a single capsule containing five drugs: a statin, aspirin and three blood pressure drugs, could significantly cut the risk of heart disease among healthy people without side effects.

The phase II clinical trial was the work of principal investigator Dr Salim Yusuf of McMaster University, Hamilton, Ontario, Canada, and colleagues, and the findings appear in the 30 March online issue of The Lancet. They were also presented at the Annual Scientific Session of the American College of Cardiology.

Yusuf, an epidemiologist and cardiologist, is a professor of medicine for the Michael G. DeGroote School of Medicine, vice-president of research and chief scientific officer at Hamilton Health Sciences and director of the Population Health Research Institute. He and colleagues did the trial in India because polypills are already available there.

The drug they tested is called Polycap, and is made by Cadila Pharmaceuticals of India. Polycap contains a beta-blocker, a diuretic, an ACE inhibitor, a statin, and aspirin. These ingredients are usually prescribed as individual drugs for treating people with cardiovascular disease or at risk of cardiovascular disease.

In the trial, known as The Indian Polycap Study (TIPS), Yusuf and colleagues tested the polypill against its component drugs and selected combinations of the components.

TIPS is the first double-blind, randomized trial to evaluate the tolerability of the Polycap as well as its impact on cardiovascular risk factors.

The findings suggested that the polypill could reduce heart disease by 62 per cent and stroke by 48 per cent but more studies are needed to decide the optimum combination of drugs that should go into the pill.

There has been a lot of debate about using polypills to protect against cardiovascular diseases.

The idea was first raised by Yusuf in an editorial in The Lancet in 2002. Two scientists, Nicholas Wald and Malcolm Law, took the idea further in an article that appeared 12 months later in the British Medical Journal. They suggested if everyone over the age of 55 and everyone with cardiovascular disease took such a pill, it would reduce the incidence of cardiovascular disease by over 80 per cent, and largely prevent heart attacks and stroke.

Yusuf told the press that:

"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 would certainly revolutionize heart disease prevention as we know it."

The polypill showed significant reductions in blood pressure and lipids and had a good safety profile, according to an editorial comment that accompanies the article.

For the trial, which lasted 3 months, researchers recruited over 2,000 healthy participants aged 45 to 80 with one cardiovascular risk factor and compared the effect of the polypill versus 8 individual drugs on blood pressure, cholesterol, heart rate, and blood plate stickiness (as measured by urinary thromboxane B2).

They found that the Polycap was well tolerated and there was no evidence of side effects. They also found that the rate of stopping the polypill was the same as for individual drugs.

"Before our study, there was 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 but we found that it works," said the researchers.

"And, side effects were no different than when taking one or two medications," they added.

Yusuf said the trial was "a critical first step to inform the design of larger, more definitive studies, as well as further development of appropriate combinations of blood-pressure-lowering drugs with statins and aspirin."

Cadila Pharmaceuticals sponsored the trial and "played no role in data collection, analysis or interpretation", according to a press statement.

"Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial."
The Lancet, Early Online Publication, 30 March 2009.
doi:10.1016/S0140-6736(09)60611-5

Sources: Journal article, McMaster Daily News.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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