Lipid-AlteringEfficacyandSafetyofSimvastatin80mgday.pptVIP

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Lipid-AlteringEfficacyandSafetyofSimvastatin80mgday.ppt

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Lipid-AlteringEfficacyandSafetyofSimvastatin80mgday.ppt

Lipid-Altering Efficacy and Safety of Simvastatin 80 mg/day:Long-Term Experience in a Large Group of Patients with Hypercholesterolemia Leiv Ose, MD, PhD, Michael H. Davidson, MD, Evan A. Stein, MD, PhD, Johannes J.P. Kastelein, MD, Russell S. Scott, MD, Donald B. Hunninghake, MD, Santiago Campodonico, MD, William Insull, MD, Ivan D. Escobar, MD, Helmut G. Schrott, MD, Michael E. Stepanavage, MS, Mei Wu, MS, Ann C. Tate, MS, Michael R. Melino PhD, Michele Mercuri, MD, Yale B. Mitchel, MD for The World Wide Expanded Dose Simvastatin Study Group Simvastatin 80mg: Background The dose-response curve for the LDL-C lowering effect of statins is log-linear, with an additional 6% reduction in LDL-C occurring with each doubling of the dose. In light of these findings, and in view of the excellent safety profile of simvastatin 20 to 40 mg/day, the efficacy of simvastatin 80 mg/day was evaluated in two large, 48 week clinical studies of similar design. This report describes the combined results from the two studies for the entire 48 week period. Simvastatin 80 mg: Study Design Both studies were controlled, double-blind, randomized and parallel-group design. Men and women ages 21-70 with LDL-C 160 mg/dL were included. The US study was conducted at 20 centers and the multinational study in 29 centers in 19 countries located in Central, North, and South America, and in Europe and Asia. Eligible patients were randomized to receive simvastatin 40 or 80 mg once daily at a 2:3 ratio for the initial 24 week base study. In the 24 week extension, patients who had started on the 80 mg dose and who were eligible for entry in the extension continued on that dose. Patients who had initially received 40 mg and who were eligible for the extension were re-randomized at a 1:1 ratio to simvastatin 40 or 80 mg/day. Simvastatin 80 mg: Endpoints Primary endpoint: Average change from baseline in LDL-C at weeks 18 and 24 combined in the 24 week base study. Change from baseline in LDL-C at week 48