Single capsule with five active ingredients may cut risk of heart disease by half
The medication, known as Polycap, combines five active pharmacological ingredients that are normally prescribed as individual therapies to patients with cardiovascular disease or at risk of cardiovascular disease.
The findings of the Phase-II clinical trial will be published today in The Lancet and presented simultaneously at the Annual Scientific Session of the American College of Cardiology by principal investigator Dr. Salim Yusuf.
Dr. Yusuf 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.
The Indian Polycap Study (TIPS) is the first double-blind, randomized trial to evaluate the tolerability of the Polycap as well as the impact of the medication on cardiovascular risk factors. The three-month study of more than 2,000 participants was conducted in India, where polypills such as the Polycap are currently available.
Researchers recruited healthy individuals between the ages of 45 and 80 with one risk factor of cardiovascular disease and compared the Polycap to eight individual pharmacological therapies. Specifically, they looked at the impact of the combination pill on blood pressure, cholesterol levels, heart rate and urinary thromboxane B2, an indicator of the stickiness of blood platelets.
"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," said Dr. Yusuf, a cardiologist and epidemiologist.
Researchers found that the Polycap was well tolerated by study participants and there was no evidence of additional side effects from the capsule. They also found that the rate of stopping the medication was the same for the Polycap as it was for individual medications.
"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. And, side effects were no different than when taking one or two medications."
The notion of a "combination pill" to combat heart disease was raised by Dr. Yusuf in a 2002 editorial published in The Lancet. A year later, two British scientists, Nicholas Wald and Malcolm Law, expanded on the idea in the British Medical Journal. The researchers hypothesized the combination pill could reduce cardiovascular disease by more than 80 per cent as well as largely prevent heart attacks and stroke if taken by everyone aged 55 and older and everyone with existing cardiovascular disease.
The findings of the TIPS study suggest that Polycap could potentially reduce heart disease by 62 per cent and stroke by 48 per cent. However, more research is needed to determine an optimal composition of the pill.
"This 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," Dr. Yusuf said.
The study was sponsored by Cadila Pharmaceuticals, India, which played no role in data collection, analysis or interpretation.