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Less small-bowel injury with lumiracoxib compared with naproxen plus omeprazole
- Hawkey, Christopher J (author)
- Ell, Christian (author)
- Simon, Bernd (author)
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- Albert, Joerg (author)
- Keuchel, Martin (author)
- Mcalindon, Mark (author)
- Fortun, Paul (author)
- Schumann, Stefan (author)
- Bolten, Wolfgang (author)
- Shonde, Anthony (author)
- Hugot, Jean-Louis (author)
- Yu, Vincent (author)
- Arulmani, Udayasankar (author)
- Krammer, Gerhard (author)
- Rebuli, Rosemary (author)
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- (creator_code:org_t)
- Elsevier BV, 2008
- 2008
- English.
- In: Clinical Gastroenterology and Hepatology. - : Elsevier BV. - 1542-7714 .- 1542-3565. ; 6:5, s. 536-544
- Journal article (peer-reviewed)
Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
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- Hawkey, Christop ...
- Ell, Christian
- Simon, Bernd
- Albert, Joerg
- Keuchel, Martin
- Mcalindon, Mark
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- Fortun, Paul
- Schumann, Stefan
- Bolten, Wolfgang
- Shonde, Anthony
- Hugot, Jean-Loui ...
- Yu, Vincent
- Arulmani, Udayas ...
- Krammer, Gerhard
- Rebuli, Rosemary
- Toth, Ervin
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