Data indicate that cyclooxygenase-2–specific inhibitors cause less gastroduodenal mucosal damage than nonspecific NSAIDS, but their effects on the small bowel mucosa are less well recognized.
Dr Goldstein and colleagues from Illinois, America undertook a multicenter, double-blind, placebo-controlled trial to evaluate the incidence of small bowel injury in healthy subjects.
The investigators treated participants with celecoxib and compared the incidence of small bowel injury using video capsule endoscopy, with those given naproxen plus omeprazole (VCE).
The research team randomly assigned subjects with normal baseline video capsule endoscopies to celecoxib 200 mg twice daily (n = 120), naproxen 500 mg twice daily plus omeprazole 20 mg once daily (n = 118), or placebo (n = 118) for 2 weeks.
The researchers looked at a primary end point of the mean number of small bowel mucosal breaks per subject.
|Magnitude of the difference between celecoxib and placebo was small but statistically significant|
|Clinical Gastroenterology and Hepatology|
Baseline video capsule endoscopy found small bowel lesions in 14% of screened subjects, who became ineligible for randomization.
The researchers found that the mean number of small bowel mucosal breaks per subject and the percentage of subjects with these mucosal breaks were 3.0, 55% for naproxen/omeprazole compared to 0.3, 16% for celecoxib and 0.1, 7% for placebo.
The research team noted that the magnitude of the difference between celecoxib and placebo was small but statistically significant.
Dr Goldstein concluded, "Among healthy subjects with lesion-free baseline VCEs, celecoxib was associated with significantly fewer small bowel mucosal breaks than naproxen plus omeprazole".
He added, "This study also showed that the background incidence of small bowel lesions in healthy adults is not insignificant and should be considered in future trials with video capsule endosopy."