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Editorial |

Arthritis Medicines and Cardiovascular Events—“House of Coxibs”

Eric J. Topol, MD
JAMA. 2005;293(3):366-368. doi:10.1001/jama.293.3.366.
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Physicians, patients, and the general public are confronted with an acute confusional state regarding the cardiovascular safety of medicines for arthritis. Since September 30, 2004, the day that rofecoxib was precipitously withdrawn, there has hardly been a day without significant news on the general topic of cyclooxygenase 2 (COX-2) inhibitors. On December 9, 2004, the US Food and Drug Administration (FDA) issued a black box warning for valdecoxib for life-threatening skin reactions and cardiovascular risk.1 Just over a week later, on December 17, 2004, the National Cancer Institute announced the premature cessation of a trial of celecoxib known as Adenoma Prevention with Celecoxib (APC) due to a significant excess of cardiovascular death, myocardial infarction (MI), and stroke.2

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Figure. Event Rates of Cardiovascular Death, Myocardial Infarction, and Stroke in the Adenoma Prevention With Celecoxib (APC) Trial
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The difference for events between the 400-mg and 800-mg dose was not significant (OR, 0.7 [95% CI, 0.4-1.4]; P =.30). OR indicates odds ratio; CI, confidence interval. The dose response trend across all groups, P =.007.



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