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CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy

CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy . Joy Mele FDA Statistical Reviewer Division of Biometrics 2. Center for Drug Evaluation and Research. Comments on Efficacy. Rosuvastatin Effect on LDL Studies 8, 33 and 65 Comparison of Rosuvastatin and Atorvastatin

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CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy

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  1. CRESTOR®(ZD4522, rosuvastatin calcium)TABLETSComments on Efficacy Joy Mele FDA Statistical Reviewer Division of Biometrics 2 Center for Drug Evaluation and Research

  2. Comments on Efficacy • Rosuvastatin Effect on LDL • Studies 8, 33 and 65 • Comparison of Rosuvastatin and Atorvastatin • Studies 33 and 65 • Rosuvastatin Effect on HDL

  3. Three Dose Response StudiesType IIa/IIb Patients Study Doses Sample Size Baseline LDL per arm 8 ROSU 1-40 14-18 ~190 33 ROSU 5-80 38-45 ~191 ATOR 10-80 65 ROSU 10-80 158-163 ~189 ATOR 10-80

  4. LDL Mean % Change from Baseline for the Dose Range of Rosuvastatin

  5. Comparability of Rosuvastatin and Atorvastatin • Rosuvastatin is significantly more potent on mg per mg basis • What doses are comparable? • 2x? 4x? • Treatment difference and 95% CI

  6. Rosuvastatin vs. 2x AtorvastatinStudies 33 + 65 - LDL % change from baselineTreatment Differences and 95% CI

  7. Rosuvastatin 40 vs. Atorvastatin 80Study 65 - LDL % Change from Baseline LOCF

  8. Rosuvastatin vs. 4x AtorvastatinStudies 33 + 65 - LDL % change from baseline Mean Treatment Differences and 95% CI

  9. HDL % Change from Baseline Rosuvastatin Compared to Placebo Study BSL 0 5 10 20 40 80 8 ~50 +3% +13%+14% +8% +9% 23 ~55 +3% +11% +15% 24 ~49 +4% +12%+12% 35 ~35 -2% +4% +6%+18%+15%+10% Treatment group n<30 in Studies 8, 23 and 35; ~128 in Study 24

  10. HDL % Change from Baseline for Atorvastatin and Rosuvastatin Study 65 Type IIa/IIb

  11. Summary • Rosuvastatin achieves about 4% more mean LDL-lowering than 2 times the dose of atorvastatin • The HDL effects are variable • No dose response relationship • Small increase for 20 mg over 10 mg • Consistent with the statin class

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