Assessing the impact of a four-in-one 'polypill' on adherence to essential medications in those at highest risk of cardiovascular disease

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An international collaboration of investigators has been established with the aim of assessing the benefits and risks of polypill-based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are planned, as the effectiveness and economic impact of a polypill-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. Primary outcomes for the individual patient data meta-analysis will include self-reported current use of antiplatelet, statin, and combination (>= 2) blood pressure lowering therapy at 12 months, and change in systolic blood pressure (SBP) and total cholesterol from baseline to 12 months. Non-inferiority margins of 3mmHg for SBP and 0.3 mmol/L for total cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of Life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events).

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