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withdrawn, there has hardly been a day without significant news on the general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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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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