Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study.

Abstract

BACKGROUND:

Although nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed globally, their chronic use increases the risk of upper gastrointestinal (GI) damage. Cyclooxygenase-2-selective NSAIDs are considered to reduce this risk. Current guidelines in Japan recommend loxoprofen sodium (loxoprofen), a pro-drug in the propionic acid class of nonselective NSAIDs, as first-line therapy in rheumatoid arthritis.

AIM:

To confirm the superiority of celecoxib, a cyclooxygenase-2-selective NSAID, to loxoprofen in the incidence of gastroduodenal (GD) endoscopic ulcers.

METHODS:

A randomised, multicentre, placebo-controlled, double-blind, phase IV clinical trial in healthy Japanese volunteers [mean age 57.5 (range: 40-74) years; >70% female], stratified by Helicobacter pylori status at screening (~40% positive) and randomised 2:2:1 to receive celecoxib 100 mg b.d., loxoprofen 60 mg t.d.s. or placebo. Primary end point was incidence of any GD endoscopic ulcers after 2 weeks of treatment.

RESULTS:

Of 190 randomised subjects, 189 received at least one dose of celecoxib (n = 76), loxoprofen (n = 76), or placebo (n = 37). Incidence of GD ulcers was 1.4%, 27.6% and 2.7% in the celecoxib, loxoprofen and placebo groups respectively (P < 0.0001 in favour of the celecoxib group); incidence of adverse events (AEs) was 34.2%, 51.3% and 21.6% in the celecoxib, loxoprofen and placebo groups respectively. No serious or severe AEs were reported.

CONCLUSIONS:

Celecoxib 100 mg b.d. was superior to loxoprofen 60 mg t.d.s. regarding the incidence of gastro-duodenal endoscopic ulcers over 2 weeks. Celecoxib was well tolerated and no major safety concerns were observed.

• Authors: C Sakamoto, T Kawai, S Nakamura, T Sugioka, J Tabira
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 37 Issue 3 Pg. 346-54 (Feb 2013) ISSN: 1365-2036 [Electronic] England
• PMID: 23216412 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 Blackwell Publishing Ltd.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase 2 Inhibitors
• Cyclooxygenase Inhibitors
• Phenylpropionates
• Pyrazoles
• Sulfonamides
• loxoprofen
• Celecoxib

Topics

• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Celecoxib
• Cyclooxygenase 2 Inhibitors (therapeutic use)
• Cyclooxygenase Inhibitors (therapeutic use)
• Double-Blind Method
• Endoscopy, Gastrointestinal
• Humans
• Incidence
• Male
• Middle Aged
• Peptic Ulcer (drug therapy, epidemiology)
• Phenylpropionates (therapeutic use)
• Pyrazoles (therapeutic use)
• Sulfonamides (therapeutic use)