4S: Scandinavian Simvastatin Survival Study

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Presentation transcript:

4S: Scandinavian Simvastatin Survival Study Purpose To determine whether simvastatin reduces morbidity and mortality in patients with high total cholesterol who have angina or previous myocardial infarction 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 1994:344:1383–9.

4S: Scandinavian Simvastatin Survival Study - TRIAL DESIGN - Multicenter, randomized, double-blind, placebo-controlled Patients 4444 patients (3617 men, 827 women), aged 35–70 years, with angina pectoris or previous MI, and high total cholesterol (210–310 mg/dL, 5.5–8.0 mmol/L); patients with MI in previous 6 months or unstable angina excluded Follow up and primary endpoint Primary endpoint: all-cause mortality. Median 5.4 years follow up Treatment Placebo or simvastatin 20 mg each evening, increased or decreased as necessary to 40 or 10 mg each evening to achieve aim of serum total cholesterol 115–200 mg/dL (3.0–5.2 mmol/L )

4S: Scandinavian Simvastatin Survival Study - RESULTS - In simvastatin group, compared with placebo, significant reduction in: All-cause mortality Fatal coronary events Combined endpoint of nonfatal or fatal coronary events Myocardial revascularization procedures (11.3 vs. 17.2%, relative risk 0.63, P<0.00001) No significant differences in noncardiovascular death, including death from cancer, trauma or suicide With simvastatin, total and LDL cholesterol and triglycerides reduced by 25%, 35% and 10%, respectively; HDL cholesterol increased by 8% Drug well tolerated (in both groups, 6% withdrawal rate due to adverse events)

4S: Scandinavian Simvastatin Survival Study - RESULTS continued - All-cause mortality Proportion 1.00 alive 0.95 0.90 0.85 Placebo Simvastatin (RR = 0.7, P=0.0003) 0.80 1 2 3 4 5 6 Years after randomization Scandinavian Simvastatin Survival Study Group. Lancet 1994;344:1383–89.

4S: Scandinavian Simvastatin Survival Study - RESULTS continued - Coronary events Placebo Simvastatin Relative risk n=2223 n=2221 P (95% CI) No. (%) No. (%) Fatal Definite acute MI 63 30 Probably MI 5 5 All 189 (8.5) 111 (5.0) 0.58 (0.46–0.73) Nonfatal* or fatal 622 (28) 431 (19) 0.66 (0.59–0.75) <0.00001 * One or more nonfatal major coronary events Scandinavian Simvastatin Survival Study Group. Lancet 1994;344:1383–89.

4S: Scandinavian Simvastatin Survival Study - RESULTS continued - Causes of noncardiovascular death Placebo Simvastatin (n=2223) (n=2221) Cancer Suicide Trauma Other Total 35 33 4 5 3 1 7 7 49 (2.2%) 46 (2.1%) Scandinavian Simvastatin Survival Study Group. Lancet 1994;344:1383–89.

4S: Scandinavian Simvastatin Survival Study - SUMMARY - In patients with angina or previous MI and high total cholesterol, simvastatin reduced: All-cause mortality Fatal and nonfatal coronary events Need for coronary artery bypass surgery or angioplasty