Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2009-3.1-4 | Award Amount: 4.15M | Year: 2010
Cardiovascular disease is the focus of this proposal as it is the leading cause of mortality worldwide. People with established vascular disease represent a target for secondary prevention using combination therapy that addresses multiple risk factors. Barriers to effective delivery of proven secondary preventative treatments create important gaps in the uptake. These gaps vary in different countries. Complexity and cost of treatment confer particularly difficult barriers; typically an individual recovering from a stroke or heart attack might be advised to take multiple medications to address cholesterol, blood pressure and platelet function. A combination once daily polypill may address these issues. Such a pill, the Red Heart Pill, has been formulated by Dr Reddys Laboratories in India. It is remarkably inexpensive with a projected annual cost in India of about 15. Evidence of safety and efficacy of this low-cost fixed-dose, once-daily polypill derived from a carefully conducted clinical trial will support its use in resource-poor countries and internationally. This project aims to evaluate whether provision of a cardiovascular polypill compared with usual medications improves adherence to therapies and clinical outcomes among high-risk patients. Further aims are to measure prescription of combination therapy, barriers to adherence, quality of life, safety, cardiovascular events, and healthcare resource consumption. The results will be used to develop recommendations for equitable access relevant to both Europe and India. India has been chosen as an ICPC partner as it is the home of a large global generic pharmaceutical company Dr Reddys and about 1 in 4 heart attacks globally occur in India. Parallel polypill projects running in Australia and New Zealand will afford the opportunity of pooling data to assess effects on cardiovascular outcomes. This synergy will enhance the generalisable impact of the UMPIRE trial.