LOS ANGELES — Coadministration of daily low-dose aspirin plus celecoxib for 1 week resulted in fewer endoscopically confirmed gastric and/or duodenal ulcers, compared with coadministration with naproxen, Dr. Jay L. Goldstein said at the annual Digestive Disease Week.
Dr. Goldstein and associates at the University of Illinois, Chicago, randomized 661 patients aged 50–75 years in a 2:2:1 fashion into one of three treatment arms after baseline endoscopy: celecoxib 200 mg once daily plus aspirin 81 mg daily (celecoxib group), naproxen 500 mg b.i.d. plus aspirin 81 mg daily (naproxen group), or placebo plus aspirin 81 mg daily (placebo group). Patients took the drugs for 7 days and underwent final endoscopy on day 7.
Exclusion criteria included any NSAID use prior to baseline endoscopy; being seropositive for Helicobacter pylori if baseline endoscopy revealed more than five erosions in the stomach or duodenum; any gastric, pyloric channel, or duodenal ulcer 3 mm or greater in diameter; or any esophageal ulcers or erosions. The primary end point was the incidence of at least one gastric or duodenal ulcer on day 7. An ulcer was defined as being 3 mm or greater in diameter.
The majority of patients in the trial were female and the mean age was 58 years, Dr. Goldstein reported.
By day 7, only 7% of patients in the celecoxib group had gastric and/or duodenal ulcers, compared with 25% of those in the naproxen group and 2% of those in the placebo group.
Compared with the naproxen group, the relative risk (RR) of developing a gastric and/or duodenal ulcer in the celecoxib group was 0.28. When they compared the celecoxib group with the placebo group, the RR was 4.78. When they compared the naproxen group with the placebo group, the RR was 16.01.
More patients taking celecoxib developed gastric ulcers, compared with those in the placebo, but there was no significant difference between the two groups in terms of the incidence of duodenal ulcers.
“These data suggest the possibility that lower doses of aspirin may not entirely negate the potential effect or benefit of a [cyclooxygenase-2] inhibitor as measured by endoscopic ulcer rates,” Dr. Goldstein said.
The study was funded by Pfizer Inc. Dr. Goldstein disclosed that he is on the speakers' bureau for Pfizer.