4S
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
Population
- 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
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 mol/L, simvastatin was superior to placebo with respect to death.