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In particular, the unpublished data show that by week 65, celecoxib was associated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
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