Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking
celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled,
double-blind 2-week study.
Author(s): Sakamoto C(1), Kawai T, Nakamura S, Sugioka T, Tabira J.
Affiliation(s): Author information:
(1)Department of Gastroenterology, Nippon Medical School, Graduate School of
Medicine, Tokyo, Japan. choitsu@nms.ac.jp
Publication date & source: 2013, Aliment Pharmacol Ther. , 37(3):346-54
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.
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