Unveiling the key findings today (Tuesday 13 November) at the American Heart Associations Scientific Sessions 2001, lead researcher Professor Rory Collins said: This is a stunning result, with massive public health implications. Weve found that cholesterol-lowering treatment can protect a far wider range of people than was previously thought, and that it can prevent strokes as well as heart attacks.
The MRC/BHF Heart Protection Study (HPS) involved 20,000 volunteers aged 40-80 years who were at high risk of coronary heart disease, but for whom there was substantial uncertainty about the balance of benefits and safety of cholesterol-lowering therapy. It specifically targeted groups of patients in which there was little direct evidence of benefit including women, the over 70s, people with diabetes, those with non-coronary vascular disease, and those with average or below-average cholesterol levels. Volunteers were allocated either 40mg daily simvastatin as cholesterol-lowering therapy, or matching dummy tablets. Study treatment and follow-up continued for an average of five and a half years in 69 UK hospitals.
The funding of 21 million (US $32 million) was provided by the UKs Medical Research Council (MRC), the British Heart Foundation (BHF), and the pharmaceutical companies Merck & Co. Inc. and Roche Vitamins Ltd. The study was, however, designed, conducted and analysed entirely independently of all funding sources by the Clinical Trial Service Unit of Oxford University. It started in 1994 and ended only last month.