A randomized, placebo-controlled study of the effects of naproxen, aspirin, celecoxib or clopidogrel on gastroduodenal mucosal healing.
BACKGROUND
Many individuals with gastroduodenal ulcers require on-going, non-steroidal anti-inflammatory drug (NSAID) or anti-platelet therapy.


OBJECTIVE
To evaluate the effects of these agents on gastroduodenal mucosal healing.


METHODS
Helicobacter pylori-negative volunteers were randomized to receive naproxen, celecoxib, aspirin, clopidogrel or placebo. Antral and duodenal lesions were created endoscopically with a biopsy forceps. After 7 days of medication dosing, each lesion was scored [from 0 (low) to 8 (high)] using a validated methodology. The primary endpoint was the mean injury score. The secondary endpoint was the percentage of subjects with > or = 1 unhealed lesion.


RESULTS
In all, 108 subjects completed the study. Naproxen impaired antral lesion healing more than placebo, clopidogrel, aspirin or celecoxib (mean injury score of 4.3 vs. 3.0, 2.7, 3.2, and 3.2, respectively, P < 0.05). Naproxen impaired duodenal lesion healing more than placebo, clopidogrel or aspirin (mean injury score of 4.0 vs. 2.4, 2.6, and 2.2, respectively, P < 0.05). More subjects taking naproxen than placebo or clopidogrel had > or =1 unhealed antral lesions (72.2% vs. 36.0% and 32.0%, respectively, P < 0.05) and unhealed duodenal lesions (61.1% vs. 16.0% and 28.0%, respectively, P < 0.05).


CONCLUSIONS
Naproxen may impair gastroduodenal healing more than aspirin or celecoxib in H. pylori negative subjects. Clopidogrel did not impair mucosal healing.
Dikman
A
A
Department of Medicine (Division of Gastroenterology) and Department of Anesthesiology, The Mount Sinai Medical Center, New York, NY, USA.
Sanyal
S
S
VON Althann
C
C
Whitson
M
M
Desai
J
J
Bodian
C
C
Brooks
A
A
Bamji
N
N
Cohen
L
L
Miller
K
K
Aisenberg
J
J
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000494:pharmacology*; D001241:Aspirin / Q000008:administration & dosage / Q000494:pharmacology; D000068579:Celecoxib; D000077144:Clopidogrel; D004334:Drug Administration Schedule; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage / Q000494:pharmacology; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D011720:Pyrazoles / Q000008:administration & dosage / Q000494:pharmacology; D013449:Sulfonamides / Q000008:administration & dosage / Q000494:pharmacology; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000494:pharmacology; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D009288:Naproxen; D000077144:Clopidogrel; D000068579:Celecoxib; D013988:Ticlopidine; D001241:Aspirin