O3053 ASSESSMENT OF FUNCTIONAL IMPROVEMENT IN CHRONIC LOW BACK PAIN PATIENTS WITH ETORICOXIB USING THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE

Abstract

Aims: To evaluate the impact of etoricoxib, a cyclo-oxygenase (COX)-2 inhibitor on functional status of chronic low back pain (LBP) patients using the 24 question Roland-Morris Disability Questionnaire (RMDQ). Methods: 644 patients were assigned to receive etori-coxib (60 mg/d [n=212] or 90 mg/d [n=213]) or placebo (n=219) in two identically designed, randomized 3 month studies. Patients completed the RMDQ prior to randomization, at baseline, and 1, 2, 4, 8, and 12 weeks. The global score was analyzed as a time weighted average ranging from 0 (no pain) to 24 (unbearable pain). An exploratory analysis of patientñs response to the individual RMDQ questions at Week 12 relative to baseline was also performed for etoricoxib 60 mg versus placebo. Results: Demographics were evenly distributed between groups and studies. The average duration of LBP was 12 years. Reduction in RMDQ score over the 12 week study was greater with etoricoxib 60 mg (−6.85) and 90 mg (−6.43) than with placebo (−4.21). Treatment difference from placebo was signiþcant (P< 0.001) for etoricoxib 60 mg [−2.63 (CI: −3.6, −1.67)] and 90 mg [−2.22 (CI: 3.18, –1.26)]. Signiþcant improvement (p-values < 0.05) with etoricoxib 60 mg compared to placebo was observed on 15 of the 24 individual questions from baseline to Week 12. A strongly signiþcant improvement (p-values ≤0.003) with etoricoxib 60 mg compared to placebo was observed on nine of the 24 questions. Conclusions: Etoricoxib provided signiþcant improvement in functional status assessed with the Roland-Morris Disability Questionnaire. The activities with the most signiþcant level of improvement with etoricoxib included: pain/discomfort, standing/walking, getting out of a chair, getting dressed, and walking up steps.