The SPACE group includes collaborators conducting or planning a series of clinical trials of a polypill strategy for cardiovascular disease prevention. The polypill being evaluated in these trials is the Red Heart Pill made by Dr Reddy’s Laboratories (Hyderabad, India).
The polypill is a single capsule containing four different medicines: a cholesterol lowering medication, two blood pressure lowering medications and aspirin. These medicines are recommended as preventive treatment for people who have survived a heart attack or stroke and for people who are at high risk of such a problem. Currently many people do not benefit from appropriate preventive medicines. This is particularly true in developing countries where access and cost present difficult barriers.
Three trials have either completed or are close to completion (for more information click on the links):
- The IMPACT trial in New Zealand (funded by the New Zealand Health Research Council) has completed recruitment of 513 participants from both Maori and non-Maori populations and will complete in July 2013 with results expected by the end of 2013.
- The UMPIRE (funded by the European Commission's Seventh Framework Programme – 1004 participants in Europe (UK, Ireland and The Netherlands), 1000 patients in India) is complete and awaiting publication of results. Preliminary results were reported at the American Heart Association meeting, November, 2012 (see link for details).
- The Kanyini-GAP trial in Australia (funded by the National Health and Medical Research Council, 623 patients from both indigenous and non-indigenous populations) has completed and is awaiting publication of results.
- Funding from the Brazilian government's Ministry of Health has been secured by the Hospital do Coracao Sao Paulo to recruit 2000 patients. This trial is currently on hold awaiting trial supply.
Further trials are also planned in South Africa and China.
Each trial aims to evaluate the impact of the polypill treatment strategy on adherence to preventive medication in the varying settings of several different healthcare systems. A key question about the polypill is whether patients and prescribers will adopt it with enthusiasm. Collectively the data will be sufficient to evaluate the impact of the polypill on cardiovascular morbidity and mortality.