Less small-bowel injury with lumiracoxib compared with naproxen plus omeprazole
(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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https://lup.lub.lu.se/record/1204264
- author
- organization
- publishing date
- 2008
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Clinical Gastroenterology and Hepatology
- volume
- 6
- issue
- 5
- pages
- 536 - 544
- publisher
- Elsevier
- external identifiers
-
- wos:000255806200014
- scopus:42749086787
- pmid:18242145
- ISSN
- 1542-7714
- DOI
- 10.1016/j.cgh.2007.12.023
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Emergency medicine/Medicine/Surgery (013240200)
- 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
- 2016-04-01 12:32:35
- date last changed
- 2025-04-04 15:05:33
@article{72212034-f1aa-4c6e-ac6c-b72b95c4b606,
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. 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.}},
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}},
doi = {{10.1016/j.cgh.2007.12.023}},
volume = {{6}},
year = {{2008}},
}