Gastrointestinal tolerability of meloxicam and piroxicam: a double-blind placebo-controlled study.

Author(s): Lipscomb GR, Wallis N, Armstrong G, Rees WD

Affiliation(s): Department of Medicine, North Manchester General Hospital.

Publication date & source: 1998-08, Br J Clin Pharmacol., 46(2):133-7.

Publication type: Clinical Trial; Controlled Clinical Trial; Randomized Controlled Trial

AIMS: The aim of the study was to compare the effects of meloxicam and piroxicam on the gastroduodenal mucosa in healthy adults. METHODS: Forty-four healthy volunteers were given a 28 day course of either meloxicam 15 mg, piroxicam 20 mg or placebo. Damage to the oesophageal, gastric and duodenal mucosa was assessed, mucosal blood flow (MBF) measured at endoscopy and biopsies taken for prostaglandin content and microscopic assessment of damage before NSAID administration and during days 1, 7 and 28 of continued intake. RESULTS: Maximal macroscopic gastric mucosal damage (median grade+IQR) occurred within 24 h of piroxicam administration, the damage score increasing from 0 to 2.5 (0-3) (P=0.02) at day 1 before falling to 2.0 (0-2) at day 7 and 0 (0-1) at day 28 with resolution of damage observed in six out of the seven subjects who sustained acute injury. No significant macroscopic gastric damage occurred in either of the two other groups although some minor damage was observed in seven subjects taking placebo and five taking meloxicam. There was a trend towards piroxicam causing more acute gastric damage than meloxicam (P=0.06). Baseline antral, body and duodenal MBF were similar in all three groups. No significant changes occurred in any of the groups on any of the visits. There were also no changes in gastric mucosal prostaglandin content in any group. CONCLUSIONS: These observations suggest that meloxicam causes little acute damage to the upper gastrointestinal tract and piroxicam causes some acute gastric injury but such damage resolves in most subjects by 28 days.