Parecoxib sodium demonstrates gastrointestinal safety comparable to placebo in healthy subjects

被引:29
作者
Harris, SI
Stoltz, RR
LeComte, D
Hubbard, RC
机构
[1] Seaview Res, Miami, FL USA
[2] GFI Pharmaceut, Evansville, IN USA
[3] Pharmacia Corp, Skokie, IL USA
[4] Pfizer Global Pharmaceut, Ann Arbor, MI USA
关键词
parecoxib sodium; gastrointestinal; cyclooxygenase-2;
D O I
10.1097/00004836-200408000-00007
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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). Post-treatment endoscopy scores were analyzed at 3 levels of severity: ulcers (scores of 7), greater than or equal to11 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 : I I 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 : I I 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.
引用
收藏
页码:575 / 580
页数:6
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