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Use of Serum Cholesterol as a Biomarker and Surrogate Endpoint

FIGURE 17.3 Relation of serum cholesterol to coronary heart disease death in a population of 361,662 men aged 35—57 years. The average duration of follow-up was 6 years. (Reproduced with permission from Gotto AM Jr, LaRosa JC, Hunninghake D, Grundy SM, Wilson PW, Clarkson TB, Hay JW, Goodman DS. Circulation 1990 81 1721-33.) [Pg.280]

Role of Serum Cholesterol in the Simvastatin Development Program [Pg.280]

FIGURE 17.4 Results of a study that established the dose-response relationship betwreen sinavastatin dose and percent reduction in serum cholesterol levels in patients wdth heterozygous familial hypercholesterolemia. [Pg.281]

20 mg that subsequently was adjusted as needed to lower serum cholesterol concentrations to the range of 117-200 mg/dL. The study demonstrated that simvastatin therapy reduced total cholesterol by a mean of 25% during the study (average low-density lipoprotein cholesterol reduction was 34%), and was associated with a 34% reduction in the incidence of major coronary events. Total mortality was 30% less for patients who were treated with simvastatin than for those who received placebo. [Pg.281]

The inclusion of clinical endpoints in this larger Phase III study provided the first definite evidence that lipid-lowering therapy could reduce total mortality in patients with coronary heart disease. Subgroup [Pg.281]


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Surrogate endpoints

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