CHOLESTEROL-LOWERING THERAPY IN WOMEN AND ELDERLY PATIENTS WITH MYOCARDIAL-INFARCTION OR ANGINA-PECTORIS - FINDINGS FROM THE SCANDINAVIAN SIMVASTATIN SURVIVAL STUDY (4S)

Background The Scandinavian Simvastatin Survival Study (4S) demonstrat ed pronounced reductions in mortality and major coronary events in a c ohort of patients with established coronary heart disease (CHD). The p resent study provides a detailed, post hoc assessment of the efficacy and safety of simvastatin therapy in the following subgroups of 4S pat ients: those greater than or equal to 65 years of age, those <65 years of age, women, and men. Methods and Results The 4S cohort of 4444 CHD patients included 827 women and 1021 patients greater than or equal t o 65 years of age. Total cholesterol at baseline was 5.5 to 8.0 mmol/L with triglycerides less than or equal to 2.5 mmol/L. Patients were ra ndomized to therapy with simvastatin 20 to 40 mg daily or placebo for a median follow-up period of 5.4 years. End points consisted of all-ca use and CHD mortality, major coronary events (primarily CHD death and nonfatal myocardial infarction), other acute CHD and atherosclerotic e vents, hospitalizations for CHD and cardiovascular events, and coronar y revascularization procedures. Mean changes in serum lipids were simi lar in the different subgroups. In patients greater than or equal to 6 5 years of age in the simvastatin group, relative risks (95% confidenc e intervals) for clinical events were as follows: all-cause mortality, 0.66 (0.48 to 0.90); CHD mortality, 0.57 (0.39 to 0.83); major corona ry events, 0.66 (0.52 to 0.84); any atherosclerosis-related event, 0.6 7 (0.56 to 0.81); and revascularization procedures, 0.59 (0.41 to 0.84 ). In women, the corresponding figures were 1.16 (0.68 to 1.99); 0.86 (0.42 to 1.74), 0.66 (0.48 to 0.91), 0.71 (0.56 to 0.91), and 0.51 (0. 30 to 0.86), respectively. Conclusions Cholesterol lowering with simva statin produced similar reductions in relative risk for major coronary events in women compared with men and in elderly (greater than or equ al to 65 years of age) compared with younger patients. There were too few female deaths to assess the effects on mortality in women. Because mortality rates increased substantially with age, the absolute risk r eduction for both all-cause and CHD mortality in simvastatin-treated s ubjects was approximately twice as great in the older patients.