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Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole  Christopher J. Hawkey, Christian Ell, Bernd Simon, Jörg Albert, Martin.

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Presentation on theme: "Less Small-Bowel Injury With Lumiracoxib Compared With Naproxen Plus Omeprazole  Christopher J. Hawkey, Christian Ell, Bernd Simon, Jörg Albert, Martin."— Presentation transcript:

1 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, Ervin Toth  Clinical Gastroenterology and Hepatology  Volume 6, Issue 5, Pages (May 2008) DOI: /j.cgh Copyright © 2008 AGA Institute Terms and Conditions

2 Figure 1 (A and B) Examples of subtle mucosal breaks, (C and D) more severe mucosal breaks and other small-bowel lesions such as (E) petechia, (F) focal erythema, (G) focal lymphangiectasia, and (H) diffuse lymphangiectasia. Images A, B, C, and D were adjudicated as category 2, image E was adjudicated as category 1, and images F, G, and H were adjudicated as category 9. Clinical Gastroenterology and Hepatology 2008 6, DOI: ( /j.cgh ) Copyright © 2008 AGA Institute Terms and Conditions

3 Figure 2 Subject disposition during the 16-day trial of lumiracoxib vs naproxen plus omeprazole. qd, once a day; bid, twice a day. Clinical Gastroenterology and Hepatology 2008 6, DOI: ( /j.cgh ) Copyright © 2008 AGA Institute Terms and Conditions

4 Figure 3 The proportion of subjects with at least 1 small-bowel mucosal break. ***P < .001 versus naproxen plus omeprazole (5% two-sided level using a Cochran–Mantel–Haenszel test, stratified by country). ORs (95% CI): lumiracoxib versus naproxen plus omeprazole, 0.11 (0.04–0.28); lumiracoxib versus placebo, 0.56 (0.24–1.34); naproxen plus omeprazole versus placebo, 5.19 (2.08–12.98). qb, once a day; bid, twice a day. Clinical Gastroenterology and Hepatology 2008 6, DOI: ( /j.cgh ) Copyright © 2008 AGA Institute Terms and Conditions

5 Figure 4 (A) Number and median of small-bowel breaks per treatment. ***P < .001 vs naproxen plus omeprazole (Wilcoxon rank sum test, stratified by country). The median (95% CI) for the Hodges Lehman estimate of the differences (first group minus the second group): lumiracoxib vs naproxen plus omeprazole, –7.0 (–18.0 to –2.0); lumiracoxib vs placebo, 0 (0–0); and naproxen plus omeprazole vs placebo, 7.0 (2.0–19.0). (B) Number and median of small-bowel lesions per treatment. ***P < .001 vs naproxen + omeprazole (Wilcoxon rank sum test, stratified by country). The median (95% CI) for the Hodges Lehman estimate of the differences (first group minus the second group): lumiracoxib vs naproxen plus omeprazole, –11.0 (–27.0 to –4.0); lumiracoxib vs placebo, 0 (–1.0 to 1.0); and naproxen plus omeprazole vs placebo, 12.0 (4.0–27.0). Clinical Gastroenterology and Hepatology 2008 6, DOI: ( /j.cgh ) Copyright © 2008 AGA Institute Terms and Conditions


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