The Polypill in Clinical Development – in India

The concept of a single pill that would contain different drugs to prevent cardiovascular disease - called the polypill – was first seriously mooted in 2003 by two UK physicians. They suggested that up to six different drugs of proven effectiveness and safety would be used. There was some enthusiasm for the idea, but it remained for a country with a less-developed health system to actually begin clinical development - India. The Reddy Laboratories have initiated clinical trials with a polypill containing aspirin, an ACE inhibitor, a statin, and a beta-blocking drug in 250 Indian patients who have already suffered a serious cardiac event – a heart attack or severe angina. This study explores the potential secondary preventive effect of a polypill that has been made available at three dosage strengths.

The manufacturers hope to begin a trial in primary prevention – i.e. a study in people who have never had a serious cardiovascular event, but hope to avoid one. This will use a polypill with the beta-blocker replaced by a diuretic (water pill), and will likely run in Australia, Brazil, India, South Africa, the USA, and UK, assuming the necessary permissions can be obtained. A separate trial along similar lines will be done in Maori people in New Zealand who may be at high risk of heart attack or stroke.

At present, I’m taking aspirin, an ACE inhibitor, a statin, and a diuretic, daily. You can imagine I would welcome a cheap polypill that could replace them, but I doubt that US manufacturers and the FDA will move fast enough for me to experience this in my lifetime. But, it’s the future!