6/30/23, 12:52 AM 4S Pathway Feedback Search Clinical Topics Home Studies 4S 4S Disease Disease Coronary artery disease Dyslipidemia Trial question What is the role of simvastatin in patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L? Study design Multi-center Double blinded RCT Population Characteristics of study participants 19.0% female N = 4444 81.0% male 4444 patients (827 female, 3617 male) Inclusion criteria: patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L Key exclusion criteria: secondary hypercholesterolemia, planned coronary artery surgery or angioplasty, antiarrhythmic therapy, persistent AF, cardiomegaly, impaired hepatic function, history of drug or alcohol abuse, or poor mental function Interventions N=2221 simvastatin (20 mg before evening meal) N=2223 placebo (matching placebo before evening meal) Primary outcome Death 12.0 % 12 https://web.pathway.md/studies/recZpItH5fjHW5UyR 1/2 6/30/23, 12:52 AM 4S Pathway 9.0 % 8 6.0 % Significant decrease 3.0 % NNT = 25 0.0 % Simvastatin Placebo Significant decrease in death (8% vs. 12%; RR 0.7, 95% CI 0.58 to 0.85) Secondary outcomes Significant decrease in major coronary events 1 (19% vs. 28%; RR 0.66, 95% CI 0.59 to 0.75) Significant decrease in 1 major coronary events (19% vs. 28%; RR 0.66, 95% CI 0.59 to 0.75) Safety outcomes No significant difference in adverse events. Conclusion In patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L, simvastatin was superior to placebo with respect to death. Reference Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994 Nov 19;344(8934):1383-9. Open reference URL https://web.pathway.md/studies/recZpItH5fjHW5UyR 2/2