Key result
Celecoxib 100 mg twice daily was superior to loxoprofen 60 mg three times daily regarding the incidence of gastroduodenal endoscopic ulcers over 2 weeks (1.4% vs 27.6%; P<0.0001).
Why the study?
Does celecoxib reduce the incidence of gastroduodenal endoscopic ulcers compared to loxoprofen or placebo in healthy Japanese volunteers?
RCT (n=190)
Double-blind
2:2:1
Yes
Does celecoxib reduce the incidence of gastroduodenal endoscopic ulcers compared to loxoprofen or placebo in healthy Japanese volunteers?
Absolute Event Rate: 1.4% vs 27.6%
p-value: p=<0.0001
Celecoxib significantly reduced the incidence of gastroduodenal endoscopic ulcers compared to loxoprofen over 2 weeks in healthy Japanese volunteers.
Celecoxib may be preferred over loxoprofen for short-term use to lower ulcer risk; confirms RCT superiority in healthy Japanese volunteers.
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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Sakamoto et al. (2012) conducted an RCT in Healthy volunteers (n=190). Celecoxib vs. Loxoprofen 60 mg t.d.s. or placebo was evaluated on Incidence of any gastroduodenal endoscopic ulcers after 2 weeks of treatment (p=<0.0001). Celecoxib 100 mg twice daily was superior to loxoprofen 60 mg three times daily regarding the incidence of gastroduodenal endoscopic ulcers over 2 weeks (1.4% vs 27.6%; P<0.0001).
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