Heart protection study

The Heart Protection Study is a large randomized controlled trial by the Medical Research Council (MRC) and the British Heart Foundation (BHF) in the United Kingdom. It studies the use of statin (simvastatin 40 mg) medication and vitamin supplementation (vitamin E, vitamin C and beta carotene) in patients that are at risk for cardiovascular disease.

Results
An outline of the study protocol was published in 1999. Initial results were published in 2002, which indicated that vitamins made little difference in modifying cardiovascular risk, but that simvastatin could significantly reduce the risk of cardiovascular events. Further results, from 2003 and 2004, focused on the role of simvastatin in diabetics and preventing stroke. A 2005 paper analyses the cost-effectiveness of a prescribing strategy similar to the one employed in the study.

Interpretation
The HPS is to date the largest study to investigate the use of statins in the prevention of cardiovascular disease. While there have been concerns about side-effects (myopathy and rhabdomyolysis), these were very rare in the study.

The number needed to treat in the study was 57 to prevent all deaths, and 19 to prevent all cardiovascular "events". Cancer risk was nonsignificantly lower in the treatment group (this has been the subject of other studies). No worsening of lung disease was found, an initial concern with statin drugs, but neither did simvastatin decrease osteoporosis (although it was expected to due to its pharmacological parallels with the antiosteoporotic bisphosphonates).