Celebrex: cardiovascular risk similar to Vioxx - IMMP study


Patients taking the arthritis drug Celecoxib ( Celebrex ) have a similar risk of heart attacks and stroke as those taking the withdrawn drug Rofecoxib ( Vioxx ), according to a new study by the New Zealand Intensive Medicines Monitoring Programme ( IMMP ).

Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety.

There is conflicting evidence as to whether Celecoxib, an alternative to Rofecoxib, carries the same cardiovascular risks.

This study's aim was to compare the incidence of thrombotic cardiovascular events in patients taking Celecoxib with patients taking Rofecoxib.

The University of Otago study is an interim analysis following up approximately 11,000 of the 60,000 patients prescribed either medicine during 2001.
Patients’ doctors were asked to supply information about adverse clinical events that occurred since being prescribed the drugs.

The total cohorts included 26 403 patients receiving Rofecoxib and 32 446 patients receiving Celecoxib. 4882 (18%) Rofecoxib and 6267 (19%) Celecoxib patients had been completely followed up.

The unadjusted hazard ratio for Celecoxib compared with Rofecoxib was 1.07.
After adjustment for age this hazard ratio was 0.94.
Further adjustment for sex, ‘as required’ use, indication for use, concomitant NSAID use and pre-existing cardiovascular disease resulted in only minor changes to the hazard ratio.

According to authors, this interim analysis of the Intensive Medicines Monitoring Programme data suggests that in ‘real-life’ postmarketing use in New Zealand there is no significant difference in the risk of cardiovascular thrombotic events ( heart attacks and strokes ) in patients taking Celecoxib compared with those taking Rofecoxib.

Source: Drug Safety, 2005


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