Parecoxib sodium demonstrates gastrointestinal safety comparable to placebo in healthy subjects

Abstract

Background: The gastrointestinal safety of the novel injectable cyclooxygenase-2 selective inhibitor, parecoxib sodium, was compared with the nonselective nonsteroidal anti-inflammatory drug, ketorolac, and placebo in healthy subjects.

Study: In a multicenter, randomized, double-blind, placebo-controlled design, 123 adults with endoscopically-confirmed normal upper gastrointestinal mucosae received parecoxib sodium 40 mg twice daily (7 days); placebo (2 days) followed by ketorolac 30 mg 4 times daily (5 days); or placebo (7 days) (each group n = 41). Posttreatment endoscopy scores were analyzed at 3 levels of severity: ulcers (scores of 7), > or =11 erosions/ulcers (scores of 5-7), and any erosions/ulcers (scores of 3-7).

Results: No subjects treated with parecoxib sodium or placebo developed gastroduodenal ulcers or > or =11 erosions/ulcers. Parecoxib sodium was comparable to placebo with respect to the combined incidence of erosions/ulcers (12% vs. 7%, P = 0.419). In contrast, in the ketorolac group, 11 (28%) subjects developed ulcers, 19 (48%) subjects developed > or =11 gastroduodenal erosions/ulcers, and the rate of combined ulcers/erosions was 85% (P < 0.001 vs. placebo and parecoxib sodium).

Conclusions: Parecoxib sodium 40 mg twice daily for 7 days has a gastrointestinal safety profile superior to ketorolac 30 mg 4 times daily for 5 days, and comparable to placebo.