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Clinical Advantages of Celecoxib Over NSAIDs -- How Important Are They?

The cyclooxygenase 2 (COX-2)-specific inhibitors are now being used widely because of their potentially lower risk for gastrointestinal complications compared with traditional nonsteroidal anti-inflammatory drugs (NSAIDs). But how great are the clinical advantages? In the Celecoxib Long-term Arthritis Safety Study (CLASS), an international, double-blind, randomized, controlled, manufacturer-supported trial, researchers examined the differences between COX-2 inhibitors and traditional NSAIDs in 8059 adults with osteoarthritis or rheumatoid arthritis.

Patients received celecoxib (400 mg twice daily), ibuprofen (800 mg 3 times daily), or diclofenac (75 mg twice daily). The annualized incidence rates of symptomatic upper GI ulcer complications were not significantly different for celecoxib-treated patients and those treated with the older NSAIDs (0.76 percent vs. 1.45 percent, respectively; P=0.09). The combined endpoint of upper GI complications and symptomatic gastroduodenal ulcers occurred significantly less frequently in celecoxib-treated patients (2.08 percent vs. 3.54 percent). Celecoxib treated patients also had lower rates of bleeding-related anemia (3.1 percent vs. 6.0 percent) and liver function abnormalities (0.6 percent vs.2.3 percent).

For patients who were not taking aspirin concurrently, the incidences of ulcer endpoints were significantly lower in the celecoxib group (e.g., 0.44 percent vs. 1.27 percent for ulcer complications). For patients taking aspirin (about 20 percent of both groups), these incidences were the same in the 2 groups.

Comment: These data demonstrate a lower rate of symptomatic ulcers for patients taking high doses of this COX-2 inhibitor (if they were not also taking aspirin) than for those taking NSAIDs. However, only about 1 percent or 2 percent of patients per year will benefit, and the cost of these drugs is substantially higher than that of ibuprofen. Thus, it might make sense to use COX-2 inhibitors mainly in high-risk patients (e.g., those with previous peptic ulcer).

— TH Lee

Published in Journal Watch General Medicine September 22, 2000

Citation(s):

Silverstein FE et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. The CLASS Study: A randomized controlled trial. JAMA 2000 Sep 13 284 1247-1255.

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