THURSDAY, June 17 (HealthDay News) -- The cyclooxygenase (COX)-2 selective nonsteroidal anti-inflammatory drug (NSAID) celecoxib is associated with a lower risk of gastrointestinal adverse events than the NSAID diclofenac plus the proton pump inhibitor (PPI) omeprazole in patients with osteoarthritis or rheumatoid arthritis, according to a study published online June 17 in The Lancet.
In a six-month, double-blinded study, Francis K.L. Chan, M.D., of the Chinese University of Hong Kong, and colleagues randomized 4,484 patients with osteoarthritis or rheumatoid arthritis at increased gastrointestinal risk who tested negative for Helicobacter pylori to receive either celecoxib 200 mg twice daily or diclofenac slow release 75 mg twice daily plus omeprazole 20 mg once daily. Patients were 60 years of age or older, or 18 years of age or older with previous gastrointestinal ulceration.
The researchers found that 0.9 percent of patients undergoing treatment with celecoxib and 3.8 percent of patients undergoing treatment with diclofenac plus omeprazole met criteria for the primary end point, which was a composite of clinically significant upper or lower gastrointestinal events. In addition, 281 patients withdrew from the study early due to gastrointestinal adverse events, including 6 percent taking celecoxib and 8 percent taking diclofenac plus omeprazole.
"Risk of clinical outcomes throughout the gastrointestinal tract was lower in patients treated with a COX-2-selective NSAID than in those receiving a non-selective NSAID plus a PPI," the authors conclude. "These findings should encourage review of approaches to reduce risk of NSAID treatment."
The study was sponsored by Pfizer Inc. Several authors disclosed financial ties to various medical device and pharmaceutical companies, including Pfizer.
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