Volunteers are being recruited in Ireland, the Netherlands and the UK to participate in a two-year trial of a single 'polypill' designed to prevent heart attack and stroke. The trials are financed in part by the UMPIRE (Use of a multidrug pill in reducing cardiovascular events) project, which has received EUR 3 million under the Health Theme of the Seventh Framework Programme (FP7).

Cardiovascular disease is the leading cause of death worldwide. The UMPIRE project partners are focusing on people who are at risk of cardiovascular disease or who have already had a heart attack or stroke. They hope to establish whether these patients prefer to take a single pill to prevent cardiovascular events, or to stick to their usual routine of taking several pills.

Originally developed in India, the new, low-cost, one-a-day 'polypill' (also known as the 'Red Heart Pill') contains low-dose aspirin, a statin (a drug that is used to lower blood cholesterol levels) and two blood-pressure-lowering medicines. These drugs are currently prescribed separately to individuals; taken together they can halve the risk of a person having a heart attack or stroke. However, these benefits cannot be realised if patients only take the medication for a short time. At present, many people do not manage to continue taking the pills over the long term.

"The polypill idea is really simple: make it easier for people to get the medication they need by giving them just one polypill to take each day, rather than lots of different pills that may need to be taken at different times," explained Professor Simon Thom of the National Heart and Lung Institute at Imperial College London in the UK.

UMPIRE researchers will also explore whether the single-pill strategy actually reduces blood pressure and lowers cholesterol, and whether it diminishes the likelihood of patients experiencing further cardiovascular events. The results of the European trials will be combined with parallel trials being carried out in Australia and New Zealand as well as further trials awaiting approval in Brazil, Canada, China, India and South Africa. The final data will represent 7,000 patients in 10 countries.

"It's likely that combining medications in one polypill could enable people in low-income countries to have easy access to cheap preventive medication," Professor Thom stated.

The Red Heart Pill's very low cost makes it an ideal candidate for at-risk patients living in countries where individuals have limited access to healthcare, or lack the means to pay for it. If the trials are successful, the project partners plan to find ways to make the polypill available to people with low incomes in developing countries. The researchers believe that the polypill could represent a cost-effective approach to improving the quality of life of millions of people the world over.

"Polypills are being used successfully to treat other diseases like tuberculosis and HIV (human immunodeficiency virus), but we don't yet know whether they could be effective in those with cardiovascular problems," said Professor Thom. "The UMPIRE trial aims to test whether the polypill does help people take their cardiovascular medicines in the long term and whether there are any unintended problems with this approach."

Approximately 2,000 volunteers are being recruited through clinics at Imperial College Healthcare NHS (National Health Service) Trust; the Royal College of Surgeons in Ireland; University Medical Centre Utrecht, the Netherlands; the George Institute, India; the Centre for Chronic Disease Control in New Delhi, the Public Health Foundation of India; the George Institute for International Health, Sydney, Australia; and Dr Reddy's Laboratories, India.

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