Animal studies show that drugs that inhibit cyclooxygenase-2 (COX-2) reduce the number of colorectal adenomas.
In patients with familial adenomatous polyposis, studies suggest that COX-2 inhibitors may also prevent sporadic colorectal neoplasia.
Dr Monica Bertagnolli and colleagues randomly assigned patients who had adenomas removed before study entry.
The team randomized 679 to receive placebo, 685 to 200 mg or 671 to 400 mg of celecoxib twice daily.
Randomization was stratified for the use of low-dose aspirin.
|The incidence for detecting adenomas was 43% with a lower dose of celecoxib|
|New England Journal of Medicine|
The researchers performed follow-up colonoscopies were performed at 1 and 3 years after randomization.
The occurrence of newly detected colorectal adenomas was compared among the groups with the life-table extension of the Mantel-Haenszel test.
Follow-up colonoscopies were completed at year 1 in 90% of randomized patients.
The team completed colonoscopies 76% of patients at year 3.
The estimated cumulative incidence of the detection of 1 or more adenomas by year 3 was 61% for patients receiving placebo.
The researchers found that the incidence for detecting 1 or more adenomas was 43% for those receiving 200 mg of celecoxib twice a day by year 3.
The team noted that for those receiving 400 mg of celecoxib twice a day, the detection incidence was 38%.
Serious adverse events occurred in 19% of patients in the placebo group vs 20% of those in the low-dose celecoxib group.
The team noted that serious adverse events occur in 23% of those in the high-dose group.
As compared with placebo, celecoxib was associated with an increased risk of cardiovascular events.
Dr Bertagnolli's team concludes, “These findings indicate that celecoxib is an effective agent for the prevention of colorectal adenomas but, because of potential cardiovascular events, cannot be routinely recommended for this indication.”