crestor zd4522 rosuvastatin calcium tablets comments on efficacy n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy PowerPoint Presentation
Download Presentation
CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy

Loading in 2 Seconds...

play fullscreen
1 / 11

CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy - PowerPoint PPT Presentation


  • 175 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'CRESTOR ® (ZD4522, rosuvastatin calcium) TABLETS Comments on Efficacy' - meghana


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
crestor zd4522 rosuvastatin calcium tablets comments on efficacy

CRESTOR®(ZD4522, rosuvastatin calcium)TABLETSComments on Efficacy

Joy Mele

FDA Statistical Reviewer

Division of Biometrics 2

Center for Drug Evaluation and Research

comments on efficacy
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
three dose response studies type iia iib patients
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

comparability of rosuvastatin and atorvastatin
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
slide6
Rosuvastatin vs. 2x AtorvastatinStudies 33 + 65 - LDL % change from baselineTreatment Differences and 95% CI
slide8
Rosuvastatin vs. 4x AtorvastatinStudies 33 + 65 - LDL % change from baseline Mean Treatment Differences and 95% CI
hdl change from baseline rosuvastatin compared to placebo
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

summary
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