1 / 8

Celecoxib in Adenoma Prevention - The PreSAP Trial

FDA Advisory Committee on COX-2 Inhibitors & NSAIDs Gaithersburg, Maryland February 16-18, 2005 Bernard Levin, MD

pippa
Download Presentation

Celecoxib in Adenoma Prevention - The PreSAP Trial

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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. FDA Advisory Committee on COX-2 Inhibitors & NSAIDs Gaithersburg, Maryland February 16-18, 2005 Bernard Levin, MD Division of Cancer Prevention University of Texas - M.D. Anderson Cancer Center Celecoxib in Adenoma Prevention - The PreSAP Trial

  2. Pfizer’s PreSAP Trial 1,561 patients with prior sporadic adenomas Randomized 3:2 Stratified by aspirin use & clinical center Celecoxib 400 mg QD x 36 mos. Placebo x 36 mos. • Colonoscopy after 12 & 36 months evaluating recurrence; collection of all adenomas 106 clinical research sites in 32 countries

  3. PreSAP Trial - Cohort Characteristics at Baseline • Results are preliminary – results not available for all patients at time of analysis

  4. Incidence & Hazard Ratio for Hierarchical CV Composite Endpoints in the PreSAP Trial *Relative to placebo

  5. PreSAP - CV Events by Baseline Subgroups • Examined cardiovascular risk in various risk subgroups • Age, gender, baseline cv risk, etc. • No statistical evidence of a differential hazard ratio by baseline risk groups • Few events • Limited power

  6. Kaplan-Meier Estimates of the Risk of Serious CV Events in the PreSAP Trial by Treatment Arm*

  7. Kaplan-Meier Estimates of the Risk of Serious CV Events in the PreSAP Trial by Treatment Arm*

  8. Context Efficacy Risk:benefit assessments Relative GI and CV safety compared to other NSAIDs Toxicity Overall safety GI ulceration Accuracy & precision Cross-trials meta-analysis Mechanisms Dose Frequency Duration Pharmacokinetics Mitigation or risk management Risk segregation Baseline risks Metabolic polymorphisms Future Research Issues Arising from the CV Safety Data with Celecoxib in the APC and PreSAP Trials

More Related