PMID- 23216412
OWN - NLM
STAT- MEDLINE
DCOM- 20130621
LR  - 20151119
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 37
IP  - 3
DP  - 2013 Feb
TI  - Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking 
      celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, 
      double-blind 2-week study.
PG  - 346-54
LID - 10.1111/apt.12174 [doi]
AB  - 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.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Sakamoto, C
AU  - Sakamoto C
AD  - Department of Gastroenterology, Nippon Medical School, Graduate School of 
      Medicine, Tokyo, Japan. choitsu@nms.ac.jp
FAU - Kawai, T
AU  - Kawai T
FAU - Nakamura, S
AU  - Nakamura S
FAU - Sugioka, T
AU  - Sugioka T
FAU - Tabira, J
AU  - Tabira J
LA  - eng
SI  - ClinicalTrials.gov/NCT00994461
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121210
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Cyclooxygenase 2 Inhibitors)
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Phenylpropionates)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - 3583H0GZAP (loxoprofen)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Celecoxib
MH  - Cyclooxygenase 2 Inhibitors/*therapeutic use
MH  - Cyclooxygenase Inhibitors/*therapeutic use
MH  - Double-Blind Method
MH  - Endoscopy, Gastrointestinal
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Peptic Ulcer/*drug therapy/epidemiology
MH  - Phenylpropionates/*therapeutic use
MH  - Pyrazoles/*therapeutic use
MH  - Sulfonamides/*therapeutic use
EDAT- 2012/12/12 06:00
MHDA- 2013/06/25 06:00
CRDT- 2012/12/11 06:00
PHST- 2012/08/10 00:00 [received]
PHST- 2012/09/06 00:00 [revised]
PHST- 2012/11/15 00:00 [revised]
PHST- 2012/11/15 00:00 [accepted]
PHST- 2012/12/11 06:00 [entrez]
PHST- 2012/12/12 06:00 [pubmed]
PHST- 2013/06/25 06:00 [medline]
AID - 10.1111/apt.12174 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 
      Dec 10.