News:Cardiovascular risk increases with incremental doses of celecoxib
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March 31, 2008 By Alexandra M. Palmer [1]
ACC 08-Chicago, IL: Pooled data from a six-study analysis recommends the lowest dose possible of celecoxib for patients who derive benefit from the drug.
The results were presented by Dr. Scott D. Solomon at today’s American College of Cardiology Annual Scientific Sessions in Chicago.
The goal of the study was to evaluate the long-term effects of celecoxib on the risk of cardiovascular events via comparison to placebo. The primary endpoint was a cardiovascular death, heart failure, myocardial infarction, thromboembolic event and stroke composite.
The Cross trial was a placebo-controlled trial that pooled data from 6 randomized trials with a follow-up of at least three years. 7,950 non-arthritic patients were randomized to one of the following doses of celecoxib: 400 mg once daily, 200 mg two times a day or 400 mg twice a day.
Results demonstrate an increased risk of cardiovascular events with celecoxib use, no matter how much aspirin is taken at baseline. Among the dose regimens, the 400 mg daily dose was associated with the lowest primary endpoint risk (HR = 1.1). Of the remaining two dosages, administration of 400 mg celecoxib twice a day posed a greater risk than the administration of 200 mg two times a day. The HR for a composite of the doses was 1.6.
The cross trial demonstrates the association of cardiovascular risk with increased doses of celecoxib. These findings are very important clinically, as celecoxib is currently the only cyclooxygenase-2 inhibitor available in the United States.
The trial was sponsored by the National Institute of Health (NIH).
Sources
- Scott D. Solomon, Janet Wittes, Ernest Hawk, Cross Trial Safety Assessment Group. Cardiovascular Risk of Celecoxib in Six Randomized Placebo-Controlled Trials: The Cross-Trials Safety Assessment Pooled Analysis. As presented at ACC 2008.
- Late Breaking Clinical Trials Session: ACC Annual Scientific Sessions, March 31, 2008 Chicago
