Use of a multidrug pill in reducing cardiovascular events (UMPIRE)
People who have experienced a previous heart attack, stroke or other vascular disease are among those at highest risk of having a future cardiovascular event. Despite the availability of a number of simple, safe and effective drugs that reduce this risk, a substantial number of patients do not receive ‘indicated’ treatments, and particularly, appropriate combinations of these drugs that would maximise their beneficial effects.
This may be due to the complexity, inconvenience and costs associated with doctors prescribing, and patients then taking, multiple drugs. A ‘polypill’ may help improve this scenario by offering patients a simpler drug regime in the form of a single pill containing fixed-dose combinations of treatments.
As part of the SPACE collaboration, which is using a single 'Polypill' containing a combination of aspirin and blood pressure and cholesterol lowering drugs to prevent heart attacks and strokes, the UMPIRE study also tests how well patients are able to stick with this medication and maintain better health.
UMPIRE is looking at more than just the pill itself. The study will also look at the barriers for patients in adhering to their medication, how their quality of life is impacted by a cardiovascular event like a heart attack or stroke, the safety of the medication itself, how acceptable it is to doctors in prescribing the Polypill to their patients, and the impact it will have on the healthcare system. UMPIRE will provide a full picture of the impact that a single pill to avoid cardiovascular diseases can have on patients, physicians, and the healthcare system.
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. 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.
Aims
The UMPIRE Study aims to assess whether patients prescribed a polypill-based drug regime have improved adherence and clinical outcomes compared with those given usual cardiovascular medications. The polypill used in the trial contains low dose aspirin, a cholesterol lowering drug and two blood pressure lowering drugs.
The study also aims to measure the prescription of combination therapy, barriers to adherence, quality of life, safety, cardiovascular events, prescriber acceptability and healthcare resource consumption to help build a complete picture with which to evaluate the polypill.
Methods
The study is a prospective, open, randomised controlled clinical trial of a polypill-based strategy compared to usual care among approximately 2000 individuals at high risk of cardiovascular events, followed up for an average of 18 months. The study will be conducted in 3 European countries (Ireland, Netherlands, UK – total of 1000 patients) and India (total 1000 patients). The Data Management Centre for the trial will be located at The George Institute Australia.
Status
Project completed. Analyses are underway.
