Scandinavian Simvastatin Survival Study
| Scandinavian Simvastatin Survival Study | |
|---|---|
| Type of project | Multicenter clinical trial |
| Country | Scandinavian countries |
| Established | 1990s |
| Disestablished | 1990s |
| Funding | Merck |
| Status | Completed |
The Scandinavian Simvastatin Survival Study (also known under the abbreviation 4S) is a multicenter clinical trial that was performed in the 1990s in Scandinavia and sponsored by Merck.[1]
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.[2] A host of other large multicenter clinical trials followed that paved the way to widespread use of this class of pharmaceuticals.[3]
References
- ^ Lancet 1994, p. 1388.
- ^ Pedersen TR, Tobert JA (December 2004). "Simvastatin: a review". Expert Opin Pharmacother. 5 (12): 2583–96. doi:10.1517/14656566.5.12.2583. PMID 15571475.
- ^ Cholesterol Treatment Trialists' (CTT) Collaboration (2010). "Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials". Lancet. 376: 1670-1681.
- 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. PMID 7968073.
- The Scandinavian Simvastatin Survival Study Group. Design and baseline results of the Scandinavian Simvastatin Survival Study of patients with stable angina and/or previous myocardial infarction. Am J Cardiol 1993;71:393-400 PMID 8430625
- Pedersen, T.R., L.Wilhelmsen, O.Faergeman, et al.: Follow-up study of patients randomized in the Scandinavian Simvastatin Survival Study (4S) of cholesterol lowering. Am J Cardiol 2000;86:257-262 PMID 10922429