Overexpression of cyclooxygenase 2 has been associated with colorectal adenomatous polyps and cancer.
This prompts researchers to propose its inhibition as a chemopreventive intervention.
Dr Levin and colleagues from Texas conducted The Prevention of Colorectal Sporadic Adenomatous Polyps trial.
The trial was a randomized, placebo-controlled, double-blind study of the COX-2 inhibitor celecoxib given daily in a single 400-mg dose.
At 107 centers in 32 countries, the researchers randomly assigned 1561 subjects who had had adenomas removed before enrolment.
The team randomized 933 subjects to receive celecoxib or 628 to receive placebo daily, after stratification according to the use or nonuse of low-dose aspirin.
The primary outcome was detection of adenomas at either year 1 or year 3 by colonoscopy.
|The cumulative rate of adenomas detected through year 3 was 34% with celecoxib|
|New England Journal of Medicine|
The research team compared the outcome among the groups with the use of the Mantel-Cox test.
Colonoscopies were performed at year 1 on 89% of the subjects who had undergone randomization and at year 3 on 79%.
Of the 557 subjects in the placebo group, 264 had at least 1 adenoma at year 1, at year 3 or both.
The team found that of the 840 subjects in the celecoxib group who were included in the efficacy analysis, 270 had at least 1 adenoma at year 1, at year 3, or both.
The researchers noted that the cumulative rate of adenomas detected through year 3 was 34% in the celecoxib group and 49% in the placebo group.
The team observed that the cumulative rate of advanced adenomas detected through year 3 was 5% in the celecoxib group and 10% in the placebo group.
Adjudicated serious cardiovascular events occurred in 3% of subjects in the celecoxib group and 2% of those in the placebo group.
Dr Levin's team concludes, “The use of 400 mg of celecoxib once daily significantly reduced the occurrence of colorectal adenomas within 3 years after polypectomy.”