New global ‘polypill’ trials start
pharmafile | May 17, 2010 | News story | Research and Development | Dr Reddy, hypertension, polypill, statin
New trials of a daily polypill – combining aspirin, a statin and two blood pressure lowering medicines – are underway worldwide.
The hope is that this quartet of generics in the so-called “red heart pill” could save the lives of people who have had a heart attack or stroke, or are at risk.
Currently the difficulty is that such patients need multiple drugs to fulfill the same function – so a low-cost, once-daily combination could mean people are better at keeping up with their doses.
The UMPIRE (use of a multidrug pill in reducing cardiovascular events) trial will involve 1,000 patients in European at sites in London, Dublin and Utrecht, and – pending regulatory approval – another 1,000 subjects in India at approximately 30 sites.
The trial is based on two similar trials running concurrently. The Kanyini-GAP study in Australia and IMPACT (improving adherence using combination therapy) study in New Zealand, which will recruit both Maori and non-Maori people.
Like these studies, UMPIRE will evaluate whether the polypill – made by Dr Reddy’s Laboratories – improves clinical outcomes among high-risk patients compared with usual medications.
Sponsored by Imperial College, London and supported by the European Commission among others, UMPIRE will assess adherence to medication and self-reported current use of antiplatelet, statin and combination blood pressure lowering therapy.
The trial is planned to run until January 2013, with primary outcome data such as changes in blood pressure and cholesterol taken in June 2012.
Its secondary outcome measures include reasons for stopping cardiovascular medications, serious adverse events, new cardiovascular problems and “quality of life” assessments.
Treatment allocation is open label, with patients recruited from GP surgeries, hospital clinics and local advertisement.
There will be an average of 18 months follow-up, with subjects randomly allocated to the polypill or “usual care”.
Adam Hill
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