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

被引：51

作者：

Hawkey, Christopher J. ^{[1
]}

Ell, Christian ^{[2
]}

Simon, Bernd ^{[3
]}

Albert, Joerg ^{[4
]}

Keuchel, Martin ^{[5
]}

Mcalindon, Mark ^{[7
]}

Fortun, Paul ^{[1
]}

Schumann, Stefan ^{[2
]}

Bolten, Wolfgang ^{[6
]}

Shonde, Anthony ^{[1
]}

Hugot, Jean-Louis ^{[8
]}

Yu, Vincent ^{[9
]}

Arulmani, Udayasankar ^{[8
]}

Krammer, Gerhard ^{[8
]}

Rebuli, Rosemary ^{[8
]}

Toth, Ervin ^{[10
]}

机构：

[1] Univ Nottingham Hosp, Wolfson Digest Dis Ctr, Nottingham NG7 2UH, England

[2] HSK Wiesbaden, Dept Internal Med 2, Wiesbaden, Germany

[3] Kreiskrankenhaus Schwetzingen, Dept Internal Med, Schwetzingen, Switzerland

[4] Univ Halle Wittenberg, Dept Med 1, Halle, Germany

[5] Asklepios Klin Altona, Dept Med 1, Hamburg, Germany

[6] Klaus Miehlke Klin, Wiesbaden, Germany

[7] Royal Hallamshire Hosp, Sheffield S10 2JF, S Yorkshire, England

[8] Novartis Pharma AG, Basel, Switzerland

[9] Nova Pharmaceut Corp, E Hanover, NJ USA

[10] Malmo Univ Hosp, Dept Med, Malmo, Sweden

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2008年 / 6卷 / 05期

关键词：

D O I：

10.1016/j.cgh.2007.12.023

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：536 / 544

页数：9

共 51 条

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