Four in one polypill: the use of a multidrug pill in reducing cardiovascular events – (UMPIRE)
Cardiovascular diseases are a leading cause of deaths globally and in India. Effective preventative treatments are available for patients at high-risk of heart attack and stroke, but optimal therapy is often not prescribed and many patients find it difficult to adhere to complex drug regimens, particularly when they have no symptoms. The UMPIRE project is a European Commission funded, randomised controlled trial to ascertain if a strategy based on using a fixed-dose combination medication (containing low-dose aspirin, a cholesterol lowering drug - statin - and two blood pressure lowering drugs) improves adherence compared to usual care in patients at high-risk of cardiovascular events.
Aims
To assess whether provision of a fixed-dose polypill, compared to usual care, leads to better adherence and thus lower blood pressure and cholesterol levels. Secondary aims will assess barriers to adherence, quality of life, safety and cardiovascular outcomes.
Method
A total of 2000 patients (1000 patients from India in addition to 1000 patients from the UK, Netherlands, and Ireland) will be randomised to receive either the polypill or usual care, and adherence to treatment will be monitored over an average of 18 months follow-up. In India, 30 clinical centres will participate, jointly managed by The George Institute India and the Centre for Chronic Disease Control (CCDC), New Delhi.
Collaboration
This is a collaborative multi-country project involving representatives from India (The George Institute India and CCDC), UK (Imperial College London), Netherlands (Universitair Medisch Centrum Utrecht), and Ireland (Royal College of Surgeons Ireland), with overall coordination provided by Imperial College London. Other collaborators include the Public Health Foundation of India and Dr Reddy’s Laboratories, with data management provided by The George Institute in Australia. UMPIRE is a member of the SPACE (Single Pill to Avert Cardiovascular Events) Collaboration, along with another George Institute study, Kanyini-GAP – a study investigating the impact of the polypill among non-Indigenous and Indigenous Australians.
Funding Agencies
- This study is funded by the European Commission and a National Health and Medical Research Council(NHMRC) Grant .
