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.
OBJECTIVE
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).


CONCLUSIONS
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.
Goldstein
Jay L
JL
College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA. jlgoldst@uic.edu
Aisenberg
James
J
Zakko
Salam F
SF
Berger
Manuela F
MF
Dodge
William E
WE
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects*; D000068579:Celecoxib; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000139:chemically induced*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects; D011897:Random Allocation; D013276:Stomach Ulcer / Q000139:chemically induced*; D013449:Sulfonamides / Q000009:adverse effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D009288:Naproxen; D000068579:Celecoxib; D001241:Aspirin