COX-2 & 2x: Improved Safety?

3/6/01


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Table of Contents

COX-2 & 2x: Improved Safety?

100 years of NSAIDs

NSAIDs/COX-2 and FDA (Arthritis Advisory Committee meetings)

GI paragraph

“Clinically Relevant Events”

NSAIDs: Safety

NSAID template

NSAID template: liver

NSAID template: kidney

NSAID template: skin

NSAIDs: Efficacy

COX-2: Early hopes

AAC: March 24, 1998 (Safety/Toxicity Issues: COX-2)

GI warning: COX-2 changes?

Importance of Words

COX-2: Safety Advantage? (mechanism-based?)

COX-2 agents: Different?

COX-2 agents: Future?

PPT Slide

Celebrex-NDA: OA

Celebrex-NDA: RA

Celebrex-NDA: Pain

Celecoxib versus COX-2: (Efficacy Characteristics?)

Vioxx-NDA: OA

Vioxx-NDA: RA

Vioxx-NDA: Pain

COX-2 Efficacy

Long-Term Safety

COX-2: 2001+

CLASS

CLASS: basics-1

CLASS: basics-2

CLASS-Baseline demographics

Concurrent Medications

Aspirin use: CLASS

CLASS-Statistical Issues

Patient disposition-CLASS

Efficacy in OA/RA: CLASS

CLASS GI outcomes-1

CLASS GI outcomes-2

CLASS GI outcomes-3

GI Adverse Events

Adverse Events (%): CLASS

Deaths (%)

Deaths (pt-yrs)

Renal Adverse Events(%)

CV (combined) AEs (%)

Serious CV Events (%)

Hepatic Adverse Events (%)

Skin Adverse Events (%)

ASA and GI: CLASS (some observations)

ASA and CV: CLASS (some observations)

Overall Safety-GI

Overall Safety-Renal

Overall Safety-Cardiovascular

Overall Safety-Hepatobiliary

Overall Safety-Skin

Overall Safety-Deaths

Overall Safety: Celecoxib

COX-2 versus NSAID: Safety

Author: CDER USER