Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects

Abstract

Objective: The aim of this study was to compare the upper GI mucosal effects of i.v. parecoxib sodium with i.v. ketorolac tromethamine and placebo in healthy elderly subjects.

Methods: This was a two-center, double-blind, randomized, placebo-controlled study. Healthy subjects aged 65-75 yr who were shown at baseline endoscopy to have no gastric or duodenal lesions received either parecoxib sodium 40 mg b.i.d. for 7 days, ketorolac 15 mg q.i.d. for 5 days, or placebo for 7 days. Endoscopy was repeated at the end of dosing. Measures of upper GI effects were: 1) ulceration, 2) incidence of an ulcer and/or any erosions, and 3) incidence of an ulcer and/or > or = 11 erosions in the stomach, duodenum, or both.

Results: No gastric or duodenal ulcers occurred in any subjects receiving parecoxib sodium (n = 29) or placebo (n = 32). In contrast, seven (23%) of the 31 ketorolac subjects had at least one ulcer; five (16%) had gastric ulcers, and two (6%) had duodenal ulcers (p < 0.05 vs parecoxib sodium and placebo for gastroduodenal ulcers and for gastric ulcers). A total of 28 (90%) ketorolac subjects had an ulcer or at least one erosion in the stomach, compared with incidences of four (14%) and two (6%) for parecoxib sodium and placebo, respectively. Incidences of duodenal ulcers/erosions were 45% (n = 14) for ketorolac, 10% (n = 3) for parecoxib sodium, and none for placebo. The differences between ketorolac and both other treatment groups were statistically significant for both stomach and duodenum. No parecoxib sodium or placebo subjects had an ulcer or > or = 11 erosions in the stomach, compared with eight (26%) ketorolac subjects (p < 0.05 vs both parecoxib sodium and placebo). No subject in any group had > or = 11 duodenal erosions.

Conclusions: These results indicate that multiple dose administration of parecoxib sodium is safe and well tolerated in healthy elderly subjects, with a decreased risk of gastroduodenal mucosal injury compared with ketorolac.