Slides-ClinicalTrialResults.ppt

* * * * * * * * * Am J Cardiol 2007; 100:1695-1664 * * * * NEJM 2008;359:2195-2207 * * * NEJM 2008;359:2195-2207 * NEJM 2008;359:2195-2207 * NEJM 2008;359:2195-2207 * NEJM 2008;359:2195-2207 * * Figure derived from Figure 11.2.1.18.3 of the Jupiter CSR in Module 5, Section 5.3.5.1. * NEJM 2009;360:1851-1861 * * * * JUPITER:Statistical Analysis Plan Primary efficacy analyses counted all events diagnosed by March 30, 2008 according to the intention to treat principle. Safety analyses included events through the closeout visit, with the last closeout visit on August 20, 2008 Statistical significance determined by a likelihood ratio test of a proportional hazards model including only the treatment assignment. Validity of the proportional hazards assumption was evaluated graphically and by a likelihood ratio test of interaction between treatment effect and study time Possible heterogeneity in the relative treatment effect across subgroups evaluated through likelihood ratio tests of interaction terms in a proportional hazards model Estimates of net clinical benefits were based on the number needed to treat (NNT) over 4 years and projected to 5 years by the method of Altman and Andersen JUPITER:Baseline Blood Levels (Median, Interquartile Range) Rosuvastatin(N=8901) Placebo(n=8901) hsCRP mg/L 4.2 (2.8 – 7.1) 4.3 (2.8 – 7.2) LDL mg/dL mmol/L 108 (94 – 119) 2.8 (2.43 – 3.08) 108 (94 – 119) 2.8 (2.43 – 3.08) HDL mg/dL mmol/L 49 (40 – 60) 1.27 (1.03 – 1.55) 49 (40 – 60) 1.27 (1.03 – 1.55) Triglycerides mg/dL mmol/L 118 (85 – 169) 1.33 (0.96 –1.91) 118 (86 – 169) 1.33 (0.97 – 1.91) Total Cholesterol mg/dL mmol/L 186 (168 – 200) 4.82 (4.35 – 5.18) 185 (169 – 199) 4.79 (4.38 – 5.15) Glucose mg/dL mmol/L 94 (87 – 102) 5.22 (4.83 – 5.66) 94 (88 – 102) 5.22 (4.88 – 5.66) HbA1c % 5.7 (5.4 – 5.9) 5.7 (5.5 – 5.9) All values are median (interquartile range) [Mean LDL = 104 mg/dL (2.69 mmol/L)] JUPITER Trial Study Group, Am J Cardiol 2007; 100: 1659-1664. Compariso