Table of Contents
TROGLITAZONE: PRESENTATION TO ADVISORY COMMITTEE
Background
Background
CDER Definition of Liver Failure
Troglitazone: Analysis of AERS Reports* March 2000
Rosiglitazone: Analysis of AERS Reports* March 2000
Pioglitazone: Analysis of AERS Reports* March 2000
Questions
Possible Comparisons:
PPT Slide
Data Limitations
Spontaneous Reports
COMPARISON #1: LAUNCH vs LAUNCH
PPT Slide
Launch vs Launch Total US Prescriptions
Troglitazone: First 5 Qtrs’ experience: LVR failure onset (cumulative)
Rosiglitazone: First 3 Qtrs’ experience: LVR failure onset (cumulative)
Troglitazone vs Rosiglitazone: Liver Failure Experience from Launch (Case onset by Quarter)
End of 3rd QTR comparison
Arguments AGAINST Launch/Launch Comparison
Comparison #2: Contemporaneous
PPT Slide
Troglitazone Case onset in those starting therapy since 6/99
Rosiglitazone Case onset in those starting therapy since 6/99
Arguments FOR Contemporaneous comparison
Arguments AGAINST Contemporaneous Comparison
Arguments AGAINST Contemporaneous Comparison (contd)
Comparison #3: Total Experience vs Total Experience
PPT Slide
Case Onset since 6/99 (troglitazone could have been started anytime)
OTHER DATA/PRIORS
Other Data/”Priors”: Clinical Trials Experience
Clinical Trials Database Troglitazone
ELEVATED ALT: NDAs
Other Data/”Priors”: Hepatitis/jaundice AERS reports
Other Data/”Priors”: Hepatitis/jaundice AERS reports
Other Data/”Priors”: UHC Epidemiology Study
Other Data/”Priors”: Other population-based studies
Other Data/”Priors” DPP Study at NIH
CONCLUSIONS March 2000
CONCLUSIONS March 2000
CONCLUSIONS March 2000
CONCLUSIONS March 2000
OUTMODED DRUGS
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