The gastrointestinal safety and effect on disease activity of etoricoxib, a selective cox-2 inhibitor in inflammatory bowel diseases

BACKGROUND: While traditional nonsteroidal antiinflammatory drugs (t-NSAIDs) are relatively contraindicated in patients with inflammatory bowel disease (IBD) for fear of disease aggravation, controlled clinical trials showed that cyclo-oxygenase-2 inhibitors have fewer gastrointestinal side effects than the t-NSAIDs. Etoricoxib is a new antiinflammatory inhibitor that has high Cox-2 selectivity. OBJECTIVES: To assess the safety of etoricoxib and effect on disease activity in patients with IBD in a multicenter, double-blind, placebo-control study. METHODS: Study group included 76 patients suffering from IBD (ulcerative colitis (UC) (38), and Crohn's disease (CD) (38)). The control group included 70 patients known to have UC (35) and Crohn's disease (CD) (35). Patients of both groups were referred to the rheumatology clinic for rheumatic manifestations that require antiinflammatory therapy and were intolerable to the t-NSAIDs. The level of the IBD activity at the baseline visit, when drug/placebo therapy was initiated, was scored for all subjects included in the study. In the study group the dose of etoricoxib ranged from 60 to 120 mg tablet once a day according to their rheumatic condition. The control group received a placebo tablet once a day. Adverse events related to the use of the study medication in 1 and 3 months time were documented. Etoricoxib/placebo therapy was stopped once the patient experience flare up of their IBD. RESULTS: There was no significant difference between the patients and the control groups. After 3 months of etoricoxib therapy, 8 of 76 (10.53%) of the study group had aggravation of their underlying IBD and stopped the drug therapy, while 68 of 76 (89.5%) completed the study. The mean disease activity index before etoricoxib therapy was 1.15 + 0.794, whereas it was 1.19 + 0.683 after therapy. In the control group 8 of 70 (11.43%) experienced exacerbation of their symptoms while 62 of 70 (88.6%) completed the study. In the control group the mean disease activity before treatment was 1.16 + 0.253, whereas after placebo therapy was 1.20 + 0.481. 67 of 76 (88.2%) of the study group and 62 of 70 (88.6%) of the control group gave history of using t-NSAID therapy in addition to PPI that caused flare up of their IBD. For the patients who had to stop their drug therapy, all the adverse events occurred in the first month of drug/placebo challenge and all symptoms were reversible. CONCLUSION: Etoricoxib therapy is safe and beneficial in most patients with IBD treatment with etoricoxib was not associated with exacerbation of the underlying IBD- and GI-related complications.