Original Paper

Digestive Diseases and Sciences

, Volume 53, Issue 3, pp 647-656

Endoscopic Ulcer Rates in Healthy Subjects Associated with Use of Aspirin (81 mg q.d.) Alone or Coadministered with Celecoxib or Naproxen: A randomized, 1-Week Trial

  • Jay L. GoldsteinAffiliated withCollege of Medicine, University of Illinois at Chicago Email author 
  • , James AisenbergAffiliated withThe Mount Sinai Medical Center
  • , Salam F. ZakkoAffiliated withThe Connecticut Gastroenterology Institute at Bristol Hospital
  • , Manuela F. BergerAffiliated withPfizer Inc
  • , William E. DodgeAffiliated withPfizer Inc

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Abstract

Aim: To determine the rate of endoscopic gastric/duodenal ulcers (GDUs) associated with use of aspirin (81 mg q.d.) alone or coadministered with celecoxib or naproxen. Methods: In this multicenter, double-blind study, healthy subjects were randomized to receive daily aspirin (81 mg q.d.) plus celecoxib 200 mg q.d., naproxen 500 mg b.i.d., or placebo. Upper endoscopy was performed at baseline and day 7. The primary end point was incidence of GDUs ≥3 mm diameter. Results: Incidence of GDUs was significantly lower in subjects receiving celecoxib plus aspirin (7%) compared with naproxen plus aspirin (25.3%; relative risk [RR], 0.28 [95% confidence interval (CI), 0.17–0.45]; P < 0.001), but significantly higher than placebo plus aspirin (1.6%; RR, 4.78 [95% CI, 1.12–20.32]; P = 0.016). Conclusion: In a healthy population taking aspirin (81 mg q.d.), coadministration of celecoxib resulted in fewer GDUs than naproxen, but significantly more mucosal damage than aspirin alone.

Keywords

NSAIDs Gastric ulcer Duodenal ulcer Endoscopy Aspirin Celecoxib Naproxen