Scandinavian Simvastatin Survival Study

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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[edit]

  1. ^ Lancet 1994, p. 1388.
  2. ^ 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. 
  3. ^ 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