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. Goldstein
  • James Aisenberg
  • Salam F. Zakko
  • Manuela F. Berger
  • William E. Dodge
Original Paper

DOI: 10.1007/s10620-007-9903-4

Cite this article as:
Goldstein, J.L., Aisenberg, J., Zakko, S.F. et al. Dig Dis Sci (2008) 53: 647. doi:10.1007/s10620-007-9903-4

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

NSAIDsGastric ulcerDuodenal ulcerEndoscopyAspirinCelecoxibNaproxen

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Jay L. Goldstein
    • 1
  • James Aisenberg
    • 2
  • Salam F. Zakko
    • 3
  • Manuela F. Berger
    • 4
  • William E. Dodge
    • 4
  1. 1.College of MedicineUniversity of Illinois at ChicagoChicagoUSA
  2. 2.The Mount Sinai Medical CenterNew YorkUSA
  3. 3.The Connecticut Gastroenterology Institute at Bristol HospitalBristolUSA
  4. 4.Pfizer IncNew YorkUSA