The Scandinavian Simvastatin Survival Study (also known as the 4S study), was a multicentre, randomized, double-blind, placebo-controlled clinical trial, which provided the initial data that supported the use of the cholesterol-lowering drug, simvastatin, in people with a moderately raised cholesterol and coronary heart disease (CHD); that is people who had previously had a heart attack or angina. The study was sponsored by the pharmaceutical company Merck and enrolled 4,444 people from 94 centres in Scandinavia.
Before the 4S study, it was not proven that lowering cholesterol could prolong life in people who had CHD. The study concluded that secondary prevention with simvastatin in a high risk group with CHD reduced overall mortality by 30%.
Objective
The 4S multicentre, randomized, double-blind, placebo-controlled clinical trial enrolled 4,444 people chosen from 7,027 people who had been followed up for two months after being given dietary advice.
A second objective was to investigate whether the incidence of major coronary artery disease events (fatal and nonfatal myocardial infarction and sudden death) could be reduced with simvastatin. Of the 4,444 people enrolled in the study, 3,617 were men and 827 women,]]
After 5.4 years, compared to the group that were given placebo, the simvastatin group demonstrated a 35% reduction in LDL-C and 30% reduction in overall mortality. The overall mortality also reduced by 15% at the 10 year mark. and is considered a "landmark paper". Several other large multicenter clinical trials followed, leading to widespread use of simvastatin.
See also
- Heart Protection Study
- HDL-Atherosclerosis Treatment Study
- West of Scotland Coronary Prevention Study
- Pravastatin or atorvastatin evaluation and infection therapy - thrombolysis in myocardial infarction 22