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Cox-2 inhibitor safety questioned

August 21, 2001 7:00 AM UTC

Researchers from the Cleveland Clinic Foundation (CCF) published in the Journal of the American Medical Association analysis of two previously completed trials showing that treatment with Vioxx rofecoxib from Merck (MRK) or Celebrex celecoxib from Pharmacia (PHA) and Pfizer (PFE) may be correlated with an increase in cardiovascular event rate. Their analysis of MRK's VIGOR trial and PHA's CLASS trial showed an increase in the relative risk of thrombotic event in patients given Vioxx compared to naproxen, but no increase in event rate between Celecoxib and NSAIDs. However, they also presented a meta-analysis of patients receiving Vioxx or Celecoxib in several trials showing an increased annual MI rate compared to placebo.

PHA and PFE as well as MRK issued statements arguing for the safety of Celecoxib and Vioxx. PHA and PFE noted that the meta-analysis showed an increase in MI in Celecoxib patients compared patients who were taking low dose aspirin for cardioprotection. They said that if patients receiving aspirin was not included, the MI event rate for Celecoxib was lower than the event rate of all patients. ...