Modification of pepsinogen I levels and their correlation with gastrointestinal injury after administration of dexibuprofen, ibuprofen or diclofenac: a randomized, open-label, controlled clinical trial
Gómez, B.J.; Caunedo, A.; Redondo, L.; Esteban, J.; Sáenz-Dana, M.; Blasco, M.; Hergueta, P.; Rodríguez-Téllez, M.; Romero, R.; Pellicer, F.J.; Herrerías, J.M.
International Journal of Clinical Pharmacology and Therapeutics 44(4): 154-162
2006
ISSN/ISBN: 0946-1965 PMID: 16625984 Document Number: 2373
Objective: To assess the effect of a 2-week treatment with dexibuprofen, in comparison with ibuprofen and diclofenac, on pepsinogen plasma concentrations and gastrointestinal mucosa, as well as the correlation of these changes with gastrointestinal mucosal injury. Methods: 60 patients with rheumatologic disease in chronic therapy with NSAID, were included. After a 7-day run-in period patients were randomly assigned to receive a 14-day treatment with dexibuprofen (Group A; Day 1 - 3=400 mg t.i.d; Day 4 - 14=400 mg b.i.d.), ibuprofen (Group B; Day 1 - 3=800 mg t.i.d; Day 4 - 14=800 mg b.i.d.) or diclofenac (Group C; Day 1 - 3=50 mg t.i.d; Day 4 - 14=50 mg b.i.d.). Upper gastrointestinal endoscopy (Day 15), capsule-endoscopy (Day 16, 7 patients of each group) and determination of pepsinogen plasma concentrations were performed (basal and Day 15). A semiquantitative scale was designed for the assessment of the gastrointestinal mucosa. Results: No differences in plasma pepsinogen were found between treatment groups or gastrointestinal injury grades or between basal and post-therapy determinations. Dexibuprofen showed gastroduodenal mucosal injury in fewer patients (42.1%) than was the case with ibuprofen (5%; p=0.003) and diclofenac (30%; p=N.S.). Dexibuprofen administration was also associated with more patients having no intestinal mucosal damage (42.86% vs. 28.7% in the diclofenac group and 14.29% in the ibuprofen group; p=0.0175). The rate of clinical adverse events was similar in Groups A, B and C (28%, 38% and 34%). Conclusions: Dexibuprofen showed a lower rate of gastroduodenal and intestinal mucosal injury. This effect was not mediated by modifications of plasma pepsinogen levels.
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