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

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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.

Detaljer

Författare
  • Christopher J Hawkey
  • Christian Ell
  • Bernd Simon
  • Joerg Albert
  • Martin Keuchel
  • Mark Mcalindon
  • Paul Fortun
  • Stefan Schumann
  • Wolfgang Bolten
  • Anthony Shonde
  • Jean-Louis Hugot
  • Vincent Yu
  • Udayasankar Arulmani
  • Gerhard Krammer
  • Rosemary Rebuli
  • Ervin Toth
Enheter & grupper
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Gastroenterologi
Originalspråkengelska
Sidor (från-till)536-544
TidskriftClinical Gastroenterology and Hepatology
Volym6
Utgåva nummer5
StatusPublished - 2008
PublikationskategoriForskning
Peer review utfördJa