Analysis Offers Insights into Celecoxib's Cardiovascular Risk

By Jancin, Bruce | Clinical Psychiatry News, May 2008 | Go to article overview

Analysis Offers Insights into Celecoxib's Cardiovascular Risk


Jancin, Bruce, Clinical Psychiatry News


CHICAGO -- The cardiovascular risk of celecoxib is a function of both dose and dosing schedule, as well as a patient's baseline cardiovascular risk, according to a new National Cancer Institute-sponsored pooled analysis of six randomized trials.

Individuals at higher baseline cardiovascular risk, ac- cording to the Framingham risk score, had substantially higher relative as well as absolute risk of cele-coxib-related cardiovascular events than did those at low baseline risk, Dr. Scott D. Solomon explained at the annual meeting of the American College of Cardiology.

"These data should help guide rational clinical decisions regarding celecoxib use," observed Dr. Solomon of Brigham and Women's Hospital, Boston. "The data may provide a measure of confidence in prescribing celecoxib in patients with very low baseline cardiovascular risk, but would argue for caution in prescribing celecoxib in patients with high baseline cardiovascular risk."

Of the dosing regimens evaluated in the pooled analysis, 400 mg once daily was associated with a significantly lower event rate than was 200 mg b.i.d., which in turn was safer than 400 mg b.i.d., the cardiologist added.

Dr. Solomon presented the results of the Cross Trial Safety Analysis, involving 7,950 patients with 16,070 patient-years of follow-up in six placebo-controlled trials. All of the trials investigated celecoxib for conditions other than arthritis. Three studies evaluated the cyclooxygenase-2 (COX-2)-selective NSAID for secondary prevention of colonic polyps; the others involved degenerative eye disease, secondary prevention of breast cancer, and prevention of Alzheimer's disease. All but one study was sponsored by the NIH.

The rate of the primary study end point--the combination of cardiovascular death, MI, stroke, heart failure, or a thromboembolic event--was 1.1-fold greater in patients on 400 mg of celecoxib once daily than in those on placebo, 1.8-fold greater in patients on 200 mg b.i.d., and 3.1-fold greater in those on 400 mg b.i.d.

The cardiovascular risk associated with the COX-2 inhibitor was unaffected by concomitant use of low-dose aspirin.

The event rate associated with 400 mg of celecoxib once daily wasn't significantly different than with placebo. However, there were relatively few cardiovascular events in patients on this regimen, making for wide confidence intervals. …

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