Celecoxib versus Diclofenac and Omeprazole in Reducing the Risk of Recurrent Ulcer Bleeding in Patients with Arthritis

This randomized, controlled trial compared treatment with celecoxib and treatment with diclofenac plus omeprazole in patients with arthritis and ulcer bleeding. The rates of recurrent ulcer bleeding during six months of follow-up were similar in the two groups (4.9 percent in the celecoxib group and 6.4 percent in the diclofenac-plus-omeprazole group). Treatment with a COX-2–selective NSAID was not inferior to treatment with a nonselective NSAID plus a proton-pump inhibitor. Nonsteroidal antiinflammatory drugs (NSAIDs) are one of the most widely prescribed classes of drugs worldwide, with nearly $2 billion spent in the United States yearly on prescription NSAIDs alone. 1 Gastrointestinal toxic effects induced by NSAIDs are common. In the United States, an estimated 107,000 patients are hospitalized and 16,500 die each year as a result of NSAID-related ulcer complications. 2 Patients with a history of ulcer bleeding who use NSAIDs are at the highest risk for ulcer complications. 3 , 4 Current evidence indicates that concurrent therapy with NSAIDs and proton-pump inhibitors or misoprostol reduces the risk of ulcers 5 , 6 and ulcer complications. . . .