Meta-analysis of three double-blind comparative trials with sustained-release etodolac in the treatment of osteoarthritis of the knee.

Abstract

A meta-analysis was done with the final data from three trials that provided the first results relating to efficacy and safety of the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis (OA) of the knee. The studies were 4-week, double-blind, randomized, parallel-group comparisons of etodolac SR 600 mg (119 patients) against diclofenac SR 100 mg (54 patients), tenoxicam 20 mg (46 patients), or piroxicam 20 mg (18 patients). The primary efficacy parameters (assessed after 2 and 4 weeks of treatment) were physicians' and patients' overall assessments of patients' condition, night pain, and pain intensity. All patients had radiographic and clinical evidence of OA of the knee. For the meta-analysis, the data from the individual etodolac SR studies were pooled and compared with the pooled data for diclofenac SR, tenoxicam, and piroxicam. The homogeneity of the treatments across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance, including "study," "treatment," and "center within treatment" effects and their interaction. The analysis for the efficacy parameters was based on the final assessment during therapy (last visit). At baseline, the two treatment groups were comparable. Improvement rates were high in both groups (range, 68-81%), indicating that treatments were effective for most patients. No significant treatment difference was observed for the patients' overall assessment, night pain, or pain intensity. Both etodolac SR and the reference preparations were well tolerated. No clinically significant changes were noted in the laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)