Researchers will be exploring whether a new, very low cost, one-a-day combined ‘polypill’ could reduce the risk of heart attacks, strokes and other cardiovascular problems across the world, in a major new international trial that launches today.

Cardiovascular disease is the world’s biggest killer and the leading cause of loss of healthy life years.

The new ‘Red Heart Pill’ contains low-dose aspirin, a statin and two blood pressure-lowering medicines in a single polypill. It is expected to be substantially cheaper than existing medications to combat cardiovascular problems.

Researchers are now recruiting 2,000 volunteers who are at high risk of heart attack or stroke, or who have already had such a cardiovascular event, for a two-year trial of the Red Heart Pill.

The trial – called UMPIRE (Use of a Multidrug Pill In Reducing cardiovascular Events) – launches today in Ireland, England and the Netherlands and (pending regulatory approval) in India.

Related trials began earlier in the year in New Zealand and Australia and plans for further trials are also underway in Brazil, Canada, China and South Africa. Collectively these parallel trials will include around 7,000 participants in ten countries and can thereby evaluate the potential of the polypill treatment strategy to prevent cardiovascular events.

The researchers behind the trial will be investigating whether patients are more likely to stick with a preventive treatment regime using a single, one-a-day polypill, rather than multiple tablets. The researchers will also be exploring whether the Red Heart Pill is effective at reducing blood pressure and lowering cholesterol.

It is expected that the Red Heart Pill could be made available in both low and high income countries at a substantially lower cost than separate medications, providing a cost-effective approach that could potentially save millions of lives across the world.

If the treatment strategy is effective, the researchers plan to establish how the polypill could be made available to people on low incomes in countries like India, where 80% of health care is paid out of pocket and the majority of people do not currently have access to cardiovascular drugs.

In countries like Ireland, where heart medications are readily available, the researchers want to explore whether the Red Heart Pill could provide a more convenient alternative to existing medications. In European countries, the medications contained in the polypill are currently prescribed individually. Such preventive treatments are recommended by doctors, because they can more than halve the risk of cardiovascular events, but evidence shows that at present many people who start on these medicines do not continue to take them in the long term.

Professor Alice Stanton, the lead Irish Investigator on the study from RCSI and Beaumont Hospital, said: “The polypill idea is really simple: make it easier and cheaper 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. Polypills are being used successfully to treat other diseases like tuberculosis and HIV, but we don’t yet know whether they could be effective in those with cardiovascular problems. 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.”

The partners in UMPIRE are RCSI, with patients being recruited through clinics at Beaumont and Connolly Hospitals, Dublin; Imperial College, London; University Medical Centre Utrecht, The Netherlands; The George Institute, India; the Centre for Chronic Disease Control in New Delhi, part of the Public Health Foundation of India; The George Institute for International Health, Sydney; and Dr Reddy’s Laboratories, India.

Dr Brendan McAdam, Prof. David Williams (Beaumont Hospital) and Dr Eamon Dolan (Connolly Hospital) are the other Irish Co-Investigators for the UMPIRE trial.  

The UMPIRE project has received funding from the European Community's Seventh Framework Programme (FP7/2007-2013) under Grant Agreement #241849.