The study of celecoxib, involving nearly 8000 North American patients over six months, provides evidence that the new generation of NSAID drugs may achieve their objective of reducing gastrointestinal complications.
Writing in the Journal of the American Medical Association, researchers led by Dr Fred Silverstein from Seattle, USA, tell how patients with osteoarthritis or rheumatoid arthritis were assigned to receive celecoxib, ibuprofen or diclofenac.
For all patients, the annualized incidence rates of upper GI ulcer complications alone, and combined with symptomatic ulcers, for celecoxib vs. NSAIDs were 0.76% vs. 1.45% (P = 0.09) and 2.08% vs. 3.54% (P = 0.02), respectively.
For patients not taking aspirin, the annualized incidence rates of upper GI ulcer complications alone, and combined with symptomatic ulcers, for celecoxib vs. NSAIDs were 0.44% vs. 1.27% (P = 0.04) and 1.40% vs. 2.91% (P = 0.02).
Annual complicated and symptomatic ulcer rates:
NSAIDs: 3.5% (P = 0.02)
For patients taking aspirin, the annualized incidence rates of upper GI ulcer complications alone, and combined with symptomatic ulcers, for celecoxib vs. NSAIDs were 2.01% vs. 2.12% (P = 0.92) and 4.70% vs. 6.00% (P = 0.49).
Fewer celecoxib-treated patients than NSAID-treated patients experienced chronic GI blood loss, GI intolerance, hepatotoxicity, or renal toxicity. No difference was noted in the incidence of cardiovascular events between celecoxib and NSAIDs, irrespective of aspirin use.
One of the researchers, Professor Jay Goldstein from Chicago, USA, said, "The news is especially significant because many arthritis patients are unable to use, and often have to discontinue, traditional therapies because of gastrointestinal or other side effects."
Writing a commentary in JAMA, Drs David Lichtenstein and Michael Wolfe, of the Boston University School of Medicine, Massachusetts, USA, describe COX-2 inhibitors as "less than perfect". They say the evidence is "promising", but call for longer trials of the effects of these new drugs.
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