RESEARCH - Celebrex (celecoxib) prevents colorectal adenoma, but raises CVD risk

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Celecoxib prevents colorectal adenoma, but raises CVD risk

8/31/2006

By: Reuters Health

NEW YORK (Reuters Health), Aug 31 - Two international clinical trials that

included thousands of patients have documented the ability of celecoxib to

reduce the recurrence of colorectal adenomas for at least three years after

polypectomy. However, the trials also confirmed the dose-dependent increased

risk of severe cardiovascular events associated with celecoxib.

Both trials, reported in the New England Journal of Medicine for August 31,

included patients who had undergone polypectomy within months of enrollment.

Repeat colonoscopies were performed at year one and year three. The risk of

severe cardiovascular events linked to celecoxib led to early suspension of

both studies.

In the Adenoma Prevention with Celecoxib trial, led by Dr. M.

Bertagnolli at Brigham and Women's Hospital in Boston, 2035 patients were

randomly assigned to 200 mg celecoxib bid; 400 mg celecoxib bid, or placebo.

The cumulative incidence of new adenomas was 60.7% in the placebo group,

43.2% in the low-dose celecoxib group, and 37.5% in the high-dose group.

Corresponding rates of advanced adenomas were 17.2%, 7.8% and 6.3%. Active

treatment was also associated with a lower adenoma burden, defined as the

sum of the diameter of all adenomas.

However, the rates of serious cardiovascular events, including nonfatal MI,

stroke, heart failure, or death, were 2.0%, 2.6% and 3.4%, respectively. The

risk of these events was greatest among patients with a history of

cardiovascular events at baseline.

Similar results were obtained by Dr. Bernard Levin, from the University of

Texas M. D. Cancer Center in Houston, and other members of the

Prevention of Colorectal Sporadic Adenomatous Polyps. The efficacy analysis

involved 840 subjects randomly assigned to celecoxib 400 mg qd, and 557 to

placebo.

Cumulative rates of adenoma at three years were 33.6% in the celecoxib group

and 49.3% in the placebo group. The risk of advanced adenoma was

approximately doubled in the placebo group, as was the overall burden of

disease.

Serious cardiovascular events occurred in 1.9% of those in the placebo group

and 2.5% of those in the celecoxib group.

Editorialists, Dr. Bruce M. Psaty and Dr. D. Potter praise both trials

for reporting the efficacy and safety profiles for patients at risk of

recurrent adenomas for the first time.

However, the physicians, from the University of Washington in Seattle, add

that " the increased incidence of cardiovascular events caused by celecoxib

outweighs what may be an optimistic projection of its potential benefit in

decreasing colorectal-cancer events. "

They therefore agree with the trial authors that the drug " has no role as a

chemopreventive agent either in patients with nonfamilial colonic adenomas

or in the general population. "

Last Updated: 2006-08-30 18:57:52 -0400 (Reuters Health)

N Engl J Med 2006;355:873-895,950-952.

http://www.auntminnie.com/index.asp?Sec=sup & Sub=vco & Pag=dis & ItemId=72252 & wf=1215

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