CHICAGO, IL — Dr. Michael J. Langman, M.D., from University of Birmingham, England, and colleagues compared the incidence of GI side-effects of the drug rofecoxib to NSAIDs for the treatment of patients with osteoarthritis. Rofecoxib, like celecoxib, is an anti-inflammatory agent that inhibits the production of the COX-2 enzymes while allowing the COX-1 enzymes. The authors found that when compared to NSAIDs, rofecoxib was associated with a significantly lower incidence of GI toxic effects, such as upper GI tract perforations, symptomatic gastroduodenal ulcers and upper GI tract bleeding (PUBs-perforations, ulcers and bleeding). The cumulative incidence of PUBs over 12 months was significantly lower with rofecoxib vs. NSAIDs (1.3 percent vs. 1.8 percent).
The cumulative incidence of dyspeptic GI adverse experiences was also lower with rofecoxib (23.5 percent) compared to NSAIDs (25.5 percent) over six months, after which incidence rates converged.
The authors analyzed the results of eight randomized, double-blind clinical trials of rofecoxib (5,435 patients overall). According to the authors, “PUBs are rare and large numbers of patients are necessary to evaluate the rate of incidence with precision.”
“Our analysis shows that COX-2 specific inhibition with rofecoxib was associated with a significantly lower risk of PUBs relative to NSAIDs,” the authors write. “These findings are consistent with the results of studies of intestinal permeability, fecal red blood cell loss, and upper GI endoscopy with rofecoxib and indicate that risks of GI toxic effects associated with NSAIDs can be reduced by COX-2 specific inhibition.” (JAMA. 1999;282:1921-1928)
Source: The Journal of the American Medical Association (JAMA)