A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis

作者：Schnitzer Thomas J^*; Dattani I Dan; Seriolo Bruno; Schneider Hartmut; Moore Alan; Tseng Lillian; Sallstig Peter; Rebuli Rosemary; Maxwell Thomas

来源：Clinical Rheumatology, 2011, 30(11): 1433-1446.

DOI：10.1007/s10067-011-1776-4

• Anti-inflammatory agents
• nonsteroidal
• Celecoxib
• Cyclooxygenase inhibitors
• Hip
• Lumiracoxib
• Osteoarthritis
• Randomized controlled trial

The aim of this 13-week, multicenter, randomized, double-blind, double-dummy, placebo-and positive-internal (celecoxib)-controlled, parallel-group study was to demonstrate the efficacy, safety, and tolerability of lumiracoxib in primary hip osteoarthritis (OA) patients. Eligible patients (n=1,262; ACR criteria) were randomized (1:1:1) to receive lumiracoxib 100 mg once daily (o.d.) (n=427), celecoxib 200 mg o.d. (n=419), or matching placebo o.d. (n=416) administered orally. The primary objective was to compare lumiracoxib 100 mg o.d. and placebo with respect to three co-primary efficacy variables: the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1 (WOMAC (TM) LK 3.1) questionnaire, the function subscale of the WOMAC (TM) LK 3.1 questionnaire, and patient's global assessment of disease activity (100-mm visual analog scale (VAS)) after 13 weeks of treatment. Of the 1,262 randomized patients, 951 completed the study. All randomized patients were included in the intention-to-treat and safety populations. Lumiracoxib was superior to the placebo (p<0.001) after 13 weeks for all three co-primary endpoints. By week 13, the patient's global assessment of disease activity (100-mm VAS) improved by 23.3 mm (+/- SD, 27.83 mm) with lumiracoxib and 13.3 mm (+/- 26.71 mm) with placebo. The WOMAC (TM) function score decreased by 10.4 (+/- 13.56) with lumiracoxib and 6.8 (+/- 12.55) with placebo. The WOMAC (TM) pain scores decreased by 3.4 (+/- 4.16) with lumiracoxib and 2.2 (+/- 3.94) with placebo at week 13. Similar results were observed for secondary endpoints: OA pain intensity and WOMAC (TM) total score. Lumiracoxib was similar to celecoxib for all three co-primary endpoints. All treatments were well tolerated. In conclusion, lumiracoxib is effective in reducing pain and improving function in hip OA patients. Clinical trial registration information: www.clinicaltrials.gov; NCT00154219

• 出版日期2011-11
• 单位西北大学