Zerbini, C and Ozturk, Zafer E. and Grifka, Joachim and Maini, M and Nilganuwong, S and Morales, R and Hupli, M and Shivaprakash, M and Giezek, H (2005) Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. CURRENT MEDICAL RESEARCH AND OPINION, 21 (12). pp. 2037-2049. ISSN 0300-7995,
Full text not available from this repository.Abstract
Background and methods: The efficacy and safety of etoricoxib 60 mg/day in patients with established chronic low back pain (CLBP) were compared with those of diclofenac 150 mg/day in a 4-week, multicentre, randomized, double-blind, parallel-group trial. Four hundred and forty-six adult patients with CLBP (Quebec Task Force on Spinal Disorders Class 1 or 2) and with worsening pain upon discontinuation of pre-study analgesic medication were enrolled in the study. The study primary efficacy endpoint was change from baseline in Low Back Pain Intensity Scale (LBP-IS) score over the 4-week treatment period. Secondary and other efficacy endpoints included: changes in Roland and Morris Disability Questionnaire (RMDQ), Patient Global Assessment of Response to Therapy (PGART) and Low Back Pain Bothersomeness Scale (LBP-BS) scores. Early efficacy was assessed using PGART and LBP-IS scores 4 h after the first dose on the mornings of Days 1, 2 and 3. The overall safety and tolerability of etoricoxib 60 mg/day during 4 weeks of treatment were also assessed. Results: The least-squares mean time-weighted change from baseline LBP-IS score over 4 weeks was -32.94 mm (95% Cl -36.25, -29.63) for etoricoxib, indicating substantial efficacy in relief of pain. The treatment difference for the primary outcome was 2.51 mm (95% Cl -1.50, 6.51), fulfilling the prespecified equivalence criterion of 95% confidence interval wholly within +/- 10 mm. Etoricoxib improved all secondary and other efficacy outcomes. There were no statistically significant between-group differences in the proportion of patients with one or more clinical adverse events (AEs) (etoricoxib 35%, diclofenac 39%), or the proportion of patients who discontinued due to AEs (etoricoxib 7%, diclofenac 5%). Conclusions: The results of this study confirm that, for adult patients with CLBP, etoricoxib 60 mg once daily over 4 weeks is effective for relief of pain and improvement of physical function and comparable to high-dose diclofenac 150 mg daily.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NONSTEROIDAL ANTIINFLAMMATORY DRUGS; CONTROLLED-TRIAL; INTENSIVE REHABILITATION; CLINICAL-TRIALS; SURGICAL STABILIZATION; RHEUMATOID-ARTHRITIS; ROFECOXIB; COST; ASSESSMENTS; IMPROVEMENT; controlled clinical trial; diclofenac; etoricoxib; low back pain |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Orthopädie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Mar 2021 10:51 |
| Last Modified: | 04 Mar 2021 10:51 |
| URI: | https://pred.uni-regensburg.de/id/eprint/35343 |
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