Programme to Improve Life and Longevity (PILL) Pilot Study
A polypill - containing several medications in one, fixed dose tablet - may help reduce the cost and complexity of reducing the risk of cardiovascular events such as heart attacks and strokes in people at risk of having them.
To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill. Secondary aims are to measure adherence, the change in diastolic blood pressure, total cholesterol, HDL cholesterol, total cholesterol: HDL cholesterol ratio, non HDL cholesterol and triglycerides, frequency of switching to open-label treatment, change in estimated CVD risk, serious adverse events and all adverse events.
PILL Pilot a randomised, multicentre, placebo-controlled, parallel group trial of a fixed dose combination medication (Polypill, containing aspirin, lisinopril, simvastatin and hydrochlorothiazide) in 400 individuals at raised risk of cardiovascular disease. Participants will include those who have an absolute risk of a major cardiovascular event in the next five years of 7.5% or more (based on the Framingham risk function and presence of other major cardiovascular risk factors) but who do not meet current guidelines for treatment with aspirin, blood pressure lowering or cholesterol lowering medications.
The trial was conducted in Australia, Brazil, India, the Netherlands, New Zealand, the UK and the US. Participants were followed up for 12 weeks during the treatment period with adverse event data collected four weeks after the completion of the treatment period. Trial results are currently being analysed and the final results will be available towards the middle of 2010.