Early intensive simvastatin may reduce CVD morbidity and mortality
Early initiation of statin therapy with high-dose atorvastatin following an acute coronary syndrome event reduces major cardiovascular events. It is uncertain whether this benefit extends to other statin drugs. The investigators randomized 4497 patients with acute coronary syndrome in a double-blind fashion (concealed allocation assignment) to receive 40 mg simvastatin per day for 1 month followed by 80 mg/d thereafter, or placebo for 4 months followed by 20 mg/d of simvastatin. Eligible subjects were between the ages of 21 and 80 years, with either non-ST-elevation acute coronary syndrome or ST-elevation myocardial infarction and a total cholesterol level of 250 mg/dL or lower. Patients were excluded if they were receiving statin therapy at the time of randomization and if coronary artery bypass graft surgery or percutaneous coronary intervention was planned within 2 weeks. Outcomes were assessed by individuals blinded to treatment group assignment. Follow-up was complete for 99% of the subjects for up to 2 years. Using intention-to-treat analysis, there was no significant difference between the 2 treatment groups for the composite endpoint of cardiovascular death, recurrent acute coronary syndrome, and stroke during the first 4 months. However, from 4 months through the end of the study there was a significant reduction in the composite endpoint: 9.3% in the placebo-plus-simvastatin group compared with 6.8% in the high-dose simvastatin-only group (hazard ratio=0.75; 95% confidence interval, 0.60-0.95; number needed to treat=40). Since this outcome was a posthoc analysis (that is, after the investigators completed the study and found no difference in their primary outcomes, they re-analyzed looking for other outcomes for statistical significance), further studies are needed to verify the results. There was no significant difference between the 2 groups in all-cause mortality at any time during the 2-year follow-up period. Significant myopathy occurred in 9 patients (0.4%) receiving simvastatin 80 mg/d. Copyright© 1995-2004 InfoPOEM, Inc. All rights reserved.
De Lemos, JA; Blazing, MA; Wiviott, SD
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