We appreciate the comments of Drs. Brinker, Bonnel, Feight and Nourjah, and we compliment Drs. Brinker and Bonnel on their upcoming publication in the American Journal of Gastroenterology.1
While we certainly agree with them that the general tolerability of the COX-2 inhibitors appears to be no better than traditional NSAIDs, the results of the CLASS2 and VIGOR3 trials unambiguously and undebatably indicate that six to 12 months’ worth of dosing with either celecoxib or rofecoxib decreased the incidence of significant GI bleeding, obstructions, perforations and symptomatic ulcers by approximately 50 to 60 percent compared with the traditional NSAIDs ibuprofen, diclofenac and naproxen.
While both celecoxib and rofecoxib have been associated with significant GI events including deaths,1,4,5 a reduction anywhere near 50 percent in the estimated 107,000 hospitalizations and 16,500 deaths annually thought to be caused by the gastropathy induced by chronic NSAID ingestion6 would represent a tremendous health care benefit.
We agree that the findings of the CLASS and VIGOR trials,2,3 performed in a relatively healthy patient population with a mean age of 60 years, may not necessarily be applicable to patients at the highest risk of GI complications, including those with previous ulcers, those on concomitant anticoagulant therapy, those on other NSAIDs and those with advanced age. More research is needed to see if this safety advantage does in fact hold in an older, "more fragile" patient population.
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