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

Research output: Contribution to journalArticle


title = "Less small-bowel injury with lumiracoxib compared with naproxen plus omeprazole",
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 Christian Ell and Bernd Simon and Joerg Albert and Martin Keuchel and Mark Mcalindon and Paul Fortun and Stefan Schumann and Wolfgang Bolten and Anthony Shonde and Jean-Louis Hugot and Vincent Yu and Udayasankar Arulmani and Gerhard Krammer and Rosemary Rebuli and Ervin Toth",
note = "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)",
year = "2008",
doi = "10.1016/j.cgh.2007.12.023",
language = "English",
volume = "6",
pages = "536--544",
journal = "Clinical Perspectives in Gastroenterology",
issn = "1542-7714",
publisher = "Elsevier",
number = "5",