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Less small-bowel injury with lumiracoxib compared with naproxen plus omeprazole

Hawkey, Christopher J; Ell, Christian; Simon, Bernd; Albert, Joerg; Keuchel, Martin; Mcalindon, Mark; Fortun, Paul; Schumann, Stefan; Bolten, Wolfgang and Shonde, Anthony, et al. (2008) In Clinical Gastroenterology and Hepatology 6(5). p.536-544
Abstract
Background & Aims: The selective cyclooxygenase-2 inhibitor lumiracoxib has been shown to reduce endoscopically detected ulcers and ulcer complications in the upper gastrointestinal tract compared with nonselective nonsteroidal anti-inflammatory drugs. We investigated whether lumiracoxib would reduce small-bowel injury compared with naproxen plus omeprazole. Methods: Healthy volunteers were randomized to receive lumiracoxib, 100 mg once daily, naproxen 500 mg twice daily plus omeprazole 20 mg once daily, or placebo in a 16-day double-blind, parallel-group study. Small-bowel mucosal injury and inflammation were assessed by video capsule endoscopy, the lactulose:L-rhamnose permeability assessment, and the fecal calprotectin test.... (More)
Background & Aims: The selective cyclooxygenase-2 inhibitor lumiracoxib has been shown to reduce endoscopically detected ulcers and ulcer complications in the upper gastrointestinal tract compared with nonselective nonsteroidal anti-inflammatory drugs. We investigated whether lumiracoxib would reduce small-bowel injury compared with naproxen plus omeprazole. Methods: Healthy volunteers were randomized to receive lumiracoxib, 100 mg once daily, naproxen 500 mg twice daily plus omeprazole 20 mg once daily, or placebo in a 16-day double-blind, parallel-group study. Small-bowel mucosal injury and inflammation were assessed by video capsule endoscopy, the lactulose:L-rhamnose permeability assessment, and the fecal calprotectin test. Results: Of 152 randomized subjects, 139 completed the study with valid video capsule endoscopies (lumiracoxib, n = 47; naproxen plus omeprazole, n = 45; placebo, n = 47). Compared with placebo, an increased number of subjects on naproxen plus omeprazole had small-bowel mucosal breaks (77.8% vs 40.4%, P < .001), with increased permeability (P = .023) and increased fecal calprotectin (increase, 96.8 vs 14.5 mg/kg for placebo; P < .001). With lumiracoxib, 27.7% of subjects had small-bowel mucosal breaks (P = .196 vs placebo; P < .001 vs naproxen), there was no increase in permeability (P = .157 vs placebo; P = .364 vs naproxen), and no increase in fecal calprotectin (-5.7 mg/kg; P = .377 vs placebo; P < .001 vs naproxen). Conclusions: As assessed by 3 different measures, acute small-bowel injury on lumiracoxib treatment is less frequent than with naproxen plus omeprazole and similar to placebo. (Less)
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publishing date
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publication status
published
subject
in
Clinical Gastroenterology and Hepatology
volume
6
issue
5
pages
536 - 544
publisher
Elsevier
external identifiers
  • wos:000255806200014
  • scopus:42749086787
ISSN
1542-7714
DOI
10.1016/j.cgh.2007.12.023
language
English
LU publication?
yes
id
72212034-f1aa-4c6e-ac6c-b72b95c4b606 (old id 1204264)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/18242145
http://www.sciencedirect.com/science/article/pii/S1542356507012013
date added to LUP
2008-09-17 12:47:55
date last changed
2017-08-06 03:50:12
@article{72212034-f1aa-4c6e-ac6c-b72b95c4b606,
  abstract     = {Background &amp; Aims: The selective cyclooxygenase-2 inhibitor lumiracoxib has been shown to reduce endoscopically detected ulcers and ulcer complications in the upper gastrointestinal tract compared with nonselective nonsteroidal anti-inflammatory drugs. We investigated whether lumiracoxib would reduce small-bowel injury compared with naproxen plus omeprazole. Methods: Healthy volunteers were randomized to receive lumiracoxib, 100 mg once daily, naproxen 500 mg twice daily plus omeprazole 20 mg once daily, or placebo in a 16-day double-blind, parallel-group study. Small-bowel mucosal injury and inflammation were assessed by video capsule endoscopy, the lactulose:L-rhamnose permeability assessment, and the fecal calprotectin test. Results: Of 152 randomized subjects, 139 completed the study with valid video capsule endoscopies (lumiracoxib, n = 47; naproxen plus omeprazole, n = 45; placebo, n = 47). Compared with placebo, an increased number of subjects on naproxen plus omeprazole had small-bowel mucosal breaks (77.8% vs 40.4%, P &lt; .001), with increased permeability (P = .023) and increased fecal calprotectin (increase, 96.8 vs 14.5 mg/kg for placebo; P &lt; .001). With lumiracoxib, 27.7% of subjects had small-bowel mucosal breaks (P = .196 vs placebo; P &lt; .001 vs naproxen), there was no increase in permeability (P = .157 vs placebo; P = .364 vs naproxen), and no increase in fecal calprotectin (-5.7 mg/kg; P = .377 vs placebo; P &lt; .001 vs naproxen). Conclusions: As assessed by 3 different measures, acute small-bowel injury on lumiracoxib treatment is less frequent than with naproxen plus omeprazole and similar to placebo.},
  author       = {Hawkey, Christopher J and Ell, Christian and Simon, Bernd and Albert, Joerg and Keuchel, Martin and Mcalindon, Mark and Fortun, Paul and Schumann, Stefan and Bolten, Wolfgang and Shonde, Anthony and Hugot, Jean-Louis and Yu, Vincent and Arulmani, Udayasankar and Krammer, Gerhard and Rebuli, Rosemary and Toth, Ervin},
  issn         = {1542-7714},
  language     = {eng},
  number       = {5},
  pages        = {536--544},
  publisher    = {Elsevier},
  series       = {Clinical Gastroenterology and Hepatology},
  title        = {Less small-bowel injury with lumiracoxib compared with naproxen plus omeprazole},
  url          = {http://dx.doi.org/10.1016/j.cgh.2007.12.023},
  volume       = {6},
  year         = {2008},
}