4S

Scandinavian Simvastatin Survival Study

Patient / Population Intervention / Exposure Comparison Outcome

In 4,444 patients with CAD and total cholesterol 5.5–8.0 mmol/L, simvastatin reduced all-cause mortality compared with placebo.

4,444

Design

Double-blind RCT, median 5.4 yr

Endpoint

All-cause mortality

Relevance

Result8.2 % vs 11.5 % (RR 0.70). Major coronary events down 34 %.

Scandinavian Simvastatin Survival Study Group. Lancet. 1994;344(8934):1383-1389. 10.1016/S0140-6736(94)90566-5

Discussion & critique

First trial to show statin mortality reduction — ended the cholesterol-controversy era. Population enriched for high baseline cholesterol; lower-LDL questions answered later.