Clinical Question: Does celecoxib (...

Clinical Question: Does celecoxib (Celebrex) increase the risk of cardiovascular events?

Setting: Outpatient (specialty)

meditation Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: This cogitation was an attempt to broaden the indication of celecoxib on determining whether it can debar recurrent colon polyps. When the rises of a similar study of rofecoxib (Vioxx) were released to the media, the authors of this thought decided to similarly analyze their existing data to gaze for cardiovascular complications.

In this application of mind 2,035 patients who were 32 to 88 years of age with a history of a single large colon adenoma or multiple adenomas were randomized to treatment with placebo, celecoxib in a dosage of 200 mg twice daily, or celecoxib in a dosage of 400 mg twice daily. assemblages were balanced at the start of the studious mood analysis was by intention to treat, and patients were followed for three years.

Cardiovascular endpoints were assessed blindly, and mortality data were available for all patients. Although 41 percent of patients had hypertension, merely 4 percent had a history of myocardial infarction (MI); 2 percent had a history of stroke; 7 percent angina; and 2 percent heart failure. After 28 to 31 years of follow-up the likelihood of cardiovascular death, MI, affliction or heart failure was 10 percent in the placebo arrange 2.3 percent in the 200-mg arrange and 3.4 percent in the 400-mg assign places to The increase in this cluster of outcomes between the 400-mg and placebo disposes was statistically significant (95 percent confidence interval [CI], 14 to 78) The difference between the 200-mg and placebo clusters just missed being statistically higher with celecoxib (95 percent CI, 09 to 55) The number be in want ofed to treat to harm with celecoxib in a dosage of 400 mg by day for three years is 42 or 126 for year of use.

Bottom Line: united additional cardiovascular event or cardiovascular death take places for every 126 patients treated for undivided year with celecoxib. There appears to be a dose-response relationship. It is difficult to justify continued use of this and other coxibs in all moreover the most exceptional circumstances. (Level of Evidence: 1b)

reflection reference: Solomon SD, et al., for the Adenoma Prevention with Celecoxib (APC) thought Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J M March 17 2005;352:1071-80

Used with permission from Ebell M Celecoxib increases risk of cardiovascular complications. Accessed online April 27 2005 at: http://www.InfoPOEMs.com.

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