4S trial

Last reviewed 02/2021

The Scandinavian Simvastatin Survival Study followed 4444 patients with moderate hypercholesterolaemia (5.5-8.0 mM) who also had symptomatic coronary heart disease for a median time of 5.4 years. Patients were aged between 35 and 70 years.

• the relative risk of death in the simvastatin group was 0.70 (p=0.0003)

• the relative risk of a major coronary event in the simvastatin group was 0.66 (p<0.00001)

• treatment reduced total cholesterol by 25% and lowered low density lipoprotein by 35%.

• even in patients whose initial LDL cholesterol levels was below 4.4 mmol/l, simvastatin reduced the risk of a major coronary event by 35%.

• 6 year survival was 91.3% in the simvastatin group against 87.6% in the placebo group

The treatment of 100 patients for six years would prevent four CHD deaths and seven non-fatal MIs.

Notes:

• the starting dose of simvastatin used in the 4S trial was simvastatin 20 mg per day. Thirty-seven per cent of patients had their dose increased to simvastatin 40mg per day after 6 months and 2 patients had their dose of simvastatin reduced to 10mg as per protocol

Reference:

1. Scandinavian Simvastatin Survival Study Group (1994). Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 344, 1383-1389.