The APC and PreSAP trials: A post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo

Nadir Arber, David Lieberman, Timothy C. Wang, Richard Zhang, George H. Sands, Monica M. Bertagnolli, Ernest T. Hawk, Craig Eagle, Javier Coindreau, Ann Zauber, Angel Lanas, Bernard Levin

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: Previous gastrointestinal (GI) outcomes of nonsteroidal anti-inflammatory drug (NSAID) trials have focused on upper GI events, although recent evidence suggests NSAID-related lower GI effects are important and clinically relevant. Objective: We assessed the long-term GI adverse event (AE) profile of celecoxib in a nonarthritis population. The aim of this post hoc analysis was to determine the incidence of serious GI AEs, using a new Clinically Significant Upper and/or Lower GI Events end point. Methods: Patients from 2 colorectal adenoma recurrence studies were included. Patients received celecoxib 200 mg/400 mg BID, 400 mg once daily, or placebo over 3 years. The analysis measured noninferiority, using a prespecified definition of noninferiority. Celecoxib was predefined to be noninferior to placebo if the upper limit of the 95% CI for the hazard ratio (HR) with celecoxib was

Original languageEnglish (US)
Pages (from-to)569-579
Number of pages11
JournalClinical Therapeutics
Volume34
Issue number3
DOIs
StatePublished - Mar 2012

Fingerprint

Celecoxib
Double-Blind Method
Gastrointestinal Tract
Placebos
Wounds and Injuries
Anti-Inflammatory Agents
Pharmaceutical Preparations
Adenoma
Recurrence
Incidence
Population

Keywords

  • Adjudication
  • Celecoxib
  • Upper and lower serious adverse events

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

The APC and PreSAP trials : A post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. / Arber, Nadir; Lieberman, David; Wang, Timothy C.; Zhang, Richard; Sands, George H.; Bertagnolli, Monica M.; Hawk, Ernest T.; Eagle, Craig; Coindreau, Javier; Zauber, Ann; Lanas, Angel; Levin, Bernard.

In: Clinical Therapeutics, Vol. 34, No. 3, 03.2012, p. 569-579.

Research output: Contribution to journalArticle

Arber, Nadir ; Lieberman, David ; Wang, Timothy C. ; Zhang, Richard ; Sands, George H. ; Bertagnolli, Monica M. ; Hawk, Ernest T. ; Eagle, Craig ; Coindreau, Javier ; Zauber, Ann ; Lanas, Angel ; Levin, Bernard. / The APC and PreSAP trials : A post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. In: Clinical Therapeutics. 2012 ; Vol. 34, No. 3. pp. 569-579.
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