Scandinavian Simvastatin Survival Study
|Scandinavian Simvastatin Survival Study|
|Type of project||Multicenter clinical trial|
The objective of the study was to assess effect of a cholesterol-lowering drug called simvastatin on mortality and morbidity in a group of 4444 patients with coronary heart disease, ages between 35 and 70 years. The patients exhibited moderate hypercholesterolemia, between 5.5 and 8.0 mmol/l. The trial showed that treatment of patients suffering from coronary heart disease with simvastatin had a lowering effect on mortality and morbidity.
2223 patients were assigned placebo and 2221 were assigned simvastatin treatment for a median period of 5.4 years. There was a 30% relative reduction in the risk of death with simvastatin treatment. The absolute coronary-heart-disease mortality was reduced from 8.5% to 5.0%, making the number needed to treat around 30 (30 patients would need to be treated to prevent one death). Additionally there was no excess morbidity of non-cardiac deaths from causes like cancer or suicide, a concern that has occasionally arisen in respect to statins.
The treatment of 100 patients for six years would prevent four deaths of the disease and seven non-fatal myocardial infarcts.
The 4S study turned out to be a milestone in cardiology and evidence-based medicine — it was clearly proven that treatment with statins changed the occurrence of events of patients with coronary heart disease. A host of other large multicenter clinical trials followed that paved the way to widespread use of this class of pharmaceuticals.
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- The Scandinavian Simvastatin Survival Study Group (November 19, 1994). "Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)". Lancet. 344: 1383–9. doi:10.1016/s0140-6736(94)90566-5. PMID 7968073.
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- Pedersen T.R.; Wilhelmsen L.; Faergeman O.; et al. (2000). "Follow-up study of patients randomized in the Scandinavian Simvastatin Survival Study (4S) of cholesterol lowering". Am J Cardiol. 86: 257–262. doi:10.1016/s0002-9149(00)00910-3. PMID 10922429.