Scandinavian Simvastatin Survival Study Group - 4S
Simvastatin vs placebo for mortality in coronary heart disease
Will simvastatin result in improved survival of patients with coronary heart disease?
Patients Enrolled: 4444
Mean Follow Up: 4.9-6.3 years (median 5.4 years)
Mean Patient Age: 35-70
Patients 35–70 years of age with angina pectoris or previous MI (≥6 months earlier) and serum cholesterol 5.5–8.0 mmol/L (mean LDL 188 mg/dL).
Unstable angina, secondary hypercholesterolemia, premenopausal women, planned coronary artery bypass surgery, congestive heart failure or angioplasty.
serum lipid levels, major coronary events
Simvastatin 20–40 mg (dose increased from 20 to 40 mg/day if target range of 3.0-5.2 mmol/L not achieved) once daily or placebo.
Simvastatin patients had a significant 30% relative risk reduction in overall mortality (8.2% vs. 11.5%; p = 0.0003), as well as 39% fewer nonfatal MIs (7.4% vs. 12.1%), 41% fewer ischemic heart disease deaths (5.0% vs. 8.5%), and 34% fewer myocardial revascularization procedures (11.3% vs. 17.2%). There was no difference between the 2 groups in the incidence of noncardiovascular deaths. Simvastatin therapy was associated with 25% lower total cholesterol(TC), 35% lower LDL, and 8% higher HDL levels. Simvastatin reduced the risk of major coronary events in ALL quartiles of baseline lipid lipid levels, including a 35% risk reduction among patients in the lowest quartile of baseline LDL. The overall rates of adverse effects were similar in the two groups. A subsequent cost analysis showed that simvastatin-treated patients had 34% fewer cardiovascular-related hospital days and that there was $3,872 savings/patient, reducing the effective drug cost by 88% to 28 cents/day (see Circulation 1996;93:1796). Other analyses have shown that women, the elderly (>65 years old), and diabetics all had significant reductions in major events (see references below).
Long-term treatment with simvastatin is safe and results in a significant reduction in all-cause mortality and coronary events in patients with coronary heart disease and baseline elevated serum cholesterol levels.
Lancet 1994;344:1383–1389. Primary report. Circulation 1996;93:1796 and N Engl J Med 1997; 336: 332-6. Cost effectiveness analyses. Circulation 1997;96:4211-18.Women and elderly analysis. Ann Intern Med 1999;59:2661-67. Diabetes analysis.
Keywords: Cholesterol, Coronary Artery Disease, Risk Reduction Behavior, Myocardial Revascularization, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Simvastatin, Drug Costs, Diabetes Mellitus
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