Source: DGNews  |  Posted 9 years ago

By Mike Fillon

ORLANDO, FL -- May 23, 2003 -- In a study using video capsule diagnostic imaging researchers found celocoxib, a cyclooxigenase 2 (COX-2) specific inhibitor, caused nine-times fewer mucosal lesions in the small bowel compared to a combination of a non-steroidal anti-inflammatory drug (NSAIDs) and an acid-reducing agent.

Results of the four-week, prospective, double-blind placebo-controlled study were reported here May 20th at 2003 Digestive Disease Week.

The researchers enrolled healthy subjects between the ages of 18 and 70 whose physical exams revealed no clinically significant abnormal laboratory tests. Potential candidates with any active gastrointestinal (GI) disease or previous history of intestinal surgery were excluded, as were those taking aspirin or NSAIDs more than three times a week for 2 weeks prior to screening, or any prescribed medication besides hormonal replacement during the study.

Results were based on a total of 339 participants who completed the study.

Subjects entered one of thee blinded treatment arms and for 2 weeks received 200 mg of celocoxib twice daily; 500 mg of naproxen twice daily plus 20 mg of omeprazole daily, or placebo.

Of the modified intent-to treat-cohort, 115 subjects received celecoxib; 111 received naproxen plus omeprazole, and 113 received placebo.

The mean numbers of small bowel mucosal breaks by agent were: celecoxib (200mg twice daily) 0.32; naproxen (500 mg twice daily) plus omeprazole (20 mg daily) 2.97; placebo 0.11 (p<0.001 across the three arms).

In the secondary analysis, the numbers of subjects who finished the study with small bowel mucosal breaks were: celecoxib 16% of 115; naproxen plus omeprazole 55% of 111; placebo 7% of 113.

"These results add further evidence that chronic blood loss and development of anaemia associated with non-specific nonsteroidal anti-inflammatory drugs may be related to medication-induced damage along the entire length of the small bowel tract," said lead researcher Jay Goldstein, MD, a professor of medicine and Vice Head for Clinical Affairs, Department of Medicine, section of Digestive and Liver Diseases, University of Illinois, in Chicago. "They also expand the celecoxib GI safety profile by broadening the concept of GI safety beyond safety in the upper GI tract alone."

Dr. Goldstein said the study also highlights an important dimension in gastroenterology previously unrecognised, as it showed that a higher percentage - 13.8% - of apparently healthy people with no history of GI symptoms or disease failed initial screening due to presence of small bowel abnormalities detected by the new capsule technology.

"These findings provide us with important new information on the background rate of mucosal abnormalities in the small bowel," said Dr. Goldstein.

The study was funded by Pfizer, Inc.

[Study title: Abnormal Small Bowel Findings Are Common in Healthy Subjects Screened for a Multi-Center, Double Blind, Randomized, Placebo-Controlled Trial Using Capsule Endoscopy. Abstract 2239]