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.

Digestive diseases and sciences

PubMedID: 17676393

Goldstein JL, Aisenberg J, Zakko SF, Berger MF, Dodge WE. 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. Dig Dis Sci. 2008;53(3):647-56.
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 >or=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.