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April 19, 2000

Rofecoxib and the Risk of Adverse Upper Gastrointestinal Effects—Reply

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

In Reply: Although rofecoxib is designated an NSAID, it differs biochemically from the comparator NSAIDs used in our analysis in that it specifically inhibits cyclooxygenase 2 (COX-2) and does not inhibit cyclooxygenase 1 (COX-1) at the doses tested.1-3 Thus, as stated in our article, "The primary hypothesis involved a biologically meaningful comparison of GI [gastrointestinal] safety with COX-2 specific inhibition versus nonspecific COX-1/COX-2 inhibition." Dr Freston is correct that the test for treatment by protocol interaction suffers from low power. We noted that there were generally too few events within any single protocol to provide precise study-specific results, and we outlined the analyses conducted to evaluate the appropriateness of assuming a common RR. We acknowledged that no PUBs occurred with nabumetone in the 1 small study that included it. It is worth noting that no PUBs occurred with rofecoxib in that study either, making that study uninformative in the combined analysis.