A study, led by Nancy A. Nussmeier at the Texas Heart Institute, St. Luke's Episcopal Hospital, in Houston, assessed the safety of Valdecoxib ( Bextra ) and its intravenous prodrug Parecoxib ( Dynastat ) in the treatment of acute pain after coronary artery bypass surgery ( CABG ).

Valdecoxib and Parecoxib are two COX-2 selective non-steroidal anti-inflammatory drug ( NSAID ).

A total of 1671 patients were randomized to receive intravenous Parecoxib for at least 3 days, followed by oral Valdecoxib through day 10; intravenous placebo followed by oral Valdecoxib; or placebo for 10 days.

As compared with the group given placebo alone, both the group given Parecoxib and Valdecoxib and the group given placebo and Valdecoxib had a higher proportion of patients with at least one confirmed adverse event ( 7.4 percent in each of these two groups vs. 4.0 percent in the placebo group; risk ratio for each comparison, 1.9 ; p 0=02 ).

In particular, cardiovascular events ( including myocardial infarction, cardiac arrest, stroke, and pulmonary embolism ) were more frequent among the patients given Parecoxib and Valdecoxib than among those given placebo ( 2.0 percent vs. 0.5 percent; risk ratio, 3.7 ; P=0.03 ).

This study has shown that use of Parecoxib and Valdecoxib after CABG is associated with an increased incidence of cardiovascular events.

Recently, the FDA ( Food and Drug Administration ) announced that a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft ( CABG ) surgery was added to the label.

Bextra is indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea ( menstrual pain ).

Source: The New England Journal of Medicine, 2005

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