Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole

Christopher J. Hawkey, Christian Ell, Bernd Simon, Jörg Albert, Martin Keuchel, Mark McAlindon, Paul Fortun, Stefan Schumann, Wolfgang Bolten, Anthony Shonde, Jean Louis Hugot, Vincent Yu, Udayasankar Arulmani, Gerhard Krammer, Rosemary Rebuli, E. Tóth

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)536-544
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume6
Issue number5
DOIs
Publication statusPublished - May 2008

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Naproxen
Omeprazole
Placebos
Wounds and Injuries
Leukocyte L1 Antigen Complex
Capsule Endoscopy
Permeability
Ulcer
Lactulose
Rhamnose
Upper Gastrointestinal Tract
lumiracoxib
Cyclooxygenase 2 Inhibitors
Healthy Volunteers
Anti-Inflammatory Agents
Inflammation

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole. / Hawkey, Christopher J.; Ell, Christian; Simon, Bernd; Albert, Jörg; Keuchel, Martin; McAlindon, Mark; Fortun, Paul; Schumann, Stefan; Bolten, Wolfgang; Shonde, Anthony; Hugot, Jean Louis; Yu, Vincent; Arulmani, Udayasankar; Krammer, Gerhard; Rebuli, Rosemary; Tóth, E.

In: Clinical Gastroenterology and Hepatology, Vol. 6, No. 5, 05.2008, p. 536-544.

Research output: Contribution to journalArticle

Hawkey, CJ, Ell, C, Simon, B, Albert, J, Keuchel, M, McAlindon, M, Fortun, P, Schumann, S, Bolten, W, Shonde, A, Hugot, JL, Yu, V, Arulmani, U, Krammer, G, Rebuli, R & Tóth, E 2008, 'Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole', Clinical Gastroenterology and Hepatology, vol. 6, no. 5, pp. 536-544. https://doi.org/10.1016/j.cgh.2007.12.023
Hawkey, Christopher J. ; Ell, Christian ; Simon, Bernd ; Albert, Jörg ; Keuchel, Martin ; McAlindon, Mark ; Fortun, Paul ; Schumann, Stefan ; Bolten, Wolfgang ; Shonde, Anthony ; Hugot, Jean Louis ; Yu, Vincent ; Arulmani, Udayasankar ; Krammer, Gerhard ; Rebuli, Rosemary ; Tóth, E. / Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole. In: Clinical Gastroenterology and Hepatology. 2008 ; Vol. 6, No. 5. pp. 536-544.
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AU - Hawkey, Christopher J.

AU - Ell, Christian

AU - Simon, Bernd

AU - Albert, Jörg

AU - Keuchel, Martin

AU - McAlindon, Mark

AU - Fortun, Paul

AU - Schumann, Stefan

AU - Bolten, Wolfgang

AU - Shonde, Anthony

AU - Hugot, Jean Louis

AU - Yu, Vincent

AU - Arulmani, Udayasankar

AU - Krammer, Gerhard

AU - Rebuli, Rosemary

AU - Tóth, E.

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N2 - 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.

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