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To the Editor: The authors of the CLASS trial¹ reported that celecoxib caused fewer symptomatic ulcers and ulcer complications than did diclofenac or ibuprofen at 6 months of follow-up.¹ We are concerned that subsequent information from the trial, which is available on the US Food and Drug Administration (FDA) Web site,² appears to contradict these conclusions. As described on the FDA Web site, the published CLASS trial differs from the original protocol in primary outcomes, statistical analysis, trial duration, and conclusions.^2-4 In particular, the unpublished data show that by week 65, celecoxib was associated with a similar number of ulcer complications as diclofenac and ibuprofen.²

Scientists at the FDA were concerned that COX-2 inhibition would interfere with the beneficial role of COX-2 in the final stages of ulcer healing and actually increase the number of complicated ulcers that occur without symptomatic warning.⁵ Therefore, the sponsor specifically listed complicated ulcers (ie, . . . [Full Text of this Article]

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