4S
Trial question
What is the role of simvastatin in patients with angina pectoris or previous MI and serum cholesterol 5.5-8.0 mmol/L?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 4444
4444 patients (827 female, 3617 male).
Inclusion criteria: patients with angina pectoris or previous MI 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
8%
12%
12.0 %
9.0 %
6.0 %
3.0 %
0.0 %
Simvastatin
Placebo
Significant
decrease ▼
NNT = 25
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 MI 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.
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