Trial signals possible cardiac problems with celecoxib (Celebrex)
Most of the UK media cover this story, which broke late Friday afternoon. A large clinical trial intended to determine whether celecoxib prevented colon polyps has been stopped early because of an increased risk of cardiovascular events in patients on active drug compared to those with placebo. It involved two dosage regimens, 400mg and 800mg daily in two doses: compared with placebo, those in the higher dose group had a 3.4 times risk of a cardiovascular event and those in the lower dose group had 2.5 times the risk. Average duration of treatment was 33 months. The trial was being run by the US National Cancer Institute (NCI), and a similar company-sponsored trial involving a single daily dose of 400mg has not apparently shown any similar effect. At present, the FDA has seen only preliminary data from the trial and will be deciding whether to take further action on celecoxib and other COX-2 inhibitors once it has more details. The EMEA notes that this group is under consideration, and advises prescribers to note carefully the warnings on use in patients with heart disease in the latest SmPC's for COX-2 inhibitors.
FDA statement, issued 17th December 2004; MHRA statement;EMEA statement
BBC News report
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