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April 19, 2000

Rofecoxib and the Risk of Adverse Upper Gastrointestinal Effects

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(15):1960-1961. doi:10.1001/jama.283.15.1957

To the Editor: In the study by Dr Langman and colleagues,1 data from several studies were pooled prospectively, and the results were interpreted to indicate that "rofecoxib was associated with a significantly lower incidence of PUBs [upper gastrointestinal tract perforations, symptomatic gastroduodenal ulcers, and upper gastrointestinal tract bleeding] than treatment with NSAIDs [nonsteroidal anti-inflammatory drugs]." The consistent use of this terminology throughout the manuscript implies that rofecoxib is not an NSAID (which it is) and that all of the drugs to which it was compared belong to a class that is dissimilar to rofecoxib. The latter conclusion cannot be supported from the data presented. The authors did certain analyses and concluded that "a common RR [relative risk for the comparators] was appropriate." The nonsignificant test for treatment by protocol interaction cannot be taken as proof of homogeneity because this test has very low power in the presence of so few events. Furthermore, with no PUBs associated with 1 of the comparators, nabumetone, there is nothing to suggest that the PUB rate of nabumetone is not as good as or better than that of rofecoxib.

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