Wellcome Trust supports clinical trial of four-in-one polypill to fight cardiovascular diseases
2 December 2010
Cardiovascular diseases (CVD), predominantly heart disease and stroke, account for approximately 30 per cent of all deaths around the world. The Polycap (TM) offers a primary prevention strategy to individuals who are at high risk for these illnesses.
Polycap comprises a mixture of three agents that reduce blood pressure - including a diuretic and a beta blocker - and a statin. All of the agents were chosen based on the evidence of their ability to reduce cardiovascular risk and their generic drug status.
The combination pill has already been tested in more than 2000 volunteers across 50 centres in India as part of the Indian Polycap Study (TIPS) published in the ‘Lancet’ in 2009. Results from that phase II trial found that use of the drug reduces the risk of coronary heart disease by 62 per cent and stroke by 48 per cent.
Speaking of the award, Mr Indravadan Modi, Chairman of Cadila Pharmaceuticals, said: "We are delighted that our innovative product has gained recognition by the UK's leading biomedical foundation, the Wellcome Trust. This award endorses our efforts in providing research-based revolutionary products in the cardio care segment."
The new funding will support the study of at least 5000 individuals with no previous history of heart attack or stroke. The placebo-controlled trial will recruit men over the age of 55 and women over 60 that have been identified as being at increased risk of CVD through a questionnaire based on family history and lifestyle factors. The investigators will assess whether taking Polycap for a period of five years can cut the risk of CVD, by monitoring the incidence of death due to heart attack, non-fatal heart attack and non-fatal stroke.
Dr Nick Dunster, Senior Business Analyst at the Wellcome Trust, commented: "Cadila have already reported positive results from previous clinical trials, and we look forward to seeing how Polycap performs in this larger phase III trial. CVD is a global problem, so a drug that can cut the risk for susceptible individuals has the potential to make a huge impact on human health the world over, not just in India."
