UMPIRE : Use of a Multidrug Pill In Reducing cardiovascular Events A randomised controlled trial of fixed-dose combination medication and usual care in those at high risk of cardiovascular disease
06 / 2010 - 06 / 2014
Background and rationale. Cardiovascular disease is the world?s biggest killer and leading cause of loss of healthy life years. 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 Reddy?s Laboratories in India. It would be relatively inexpensive. 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. 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 Trial design. Open label, randomised, controlled trial (n=2000, including 1000 in [UK + Ireland + the Netherlands] and 1000 in India) of the Red Heart Pill compared to usual care in individuals at high risk of cardiovascular disease. Aims. To assess whether provision of the Red Heart polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated medicines and clinical outcomes in high-risk patients at end of trial follow-up. Secondary aims include assessing barriers to adherence, quality of life, safety (reporting of serious adverse events), cardiovascular events, and to assess whether results are similar in Europe and India. Outcomes will also be assessed at the end of the trial, 12 months after the last participant has been randomised. Outcomes. Primary outcomes: Adherence to indicated medications (defined as self-reported current use of antiplatelet, statin and combination (? 2) blood pressure lowering therapy), change in blood pressure, change in total-cholesterol, at end of trial. Secondary outcomes: Dispensing of statin and ? 2 blood pressure lowering agents, self-reported barriers to adherence, serious adverse events, cardiovascular events, reasons for stopping cardiovascular medications, quality of life, change in other lipid fractions (HDL-cholesterol, total cholesterol, triglycerides), and comparison of results in Europe and India.