Double-blind comparison of etodolac sustained-release tablets and piroxicam capsules in patients with rheumatoid arthritis: An interim report

Abstract Etodolac SR is the sustained-release formulation of etodolac, a non-steroidal anti-inflammatory drug used in the treatment of arthritic diseases. This 4-week, double-blind, multicenter, randomized, parallel-group study was conducted to compare the efficacy and safety of etodolac SR tablets (600 mg) and piroxicam capsules (20 mg) administered once daily to patients with active rheumatoid arthritis. In this interim report, 24 patients received etodolac SR and 25 patients received piroxicam. The mean age was 58 years in the etodolac SR group and 54 years in the piroxicam group. The results show that the differences between groups with respect to changes in the efficacy parameters from baseline to the last on-therapy visit were not statistically significant. Within each group, statistically significant improvements from baseline were seen at the last on-therapy visit in the patient's and physician's overall assessments of the patient's condition, the number of painful joints, and the number of swollen joints. Statistically significant improvements were also observed within each group for pain intensity, duration of morning stiffness, average grip strength, and the articular index. No significant changes were noted for the American Rheumatism Association functional class, the time to walk 15 meters, or the erythrocyte sedimentation rate. Four patients in the etodolac SR group and seven patients in the piroxicam group reported four and 12 adverse events, respectively, that were at least possibly drug related. Adverse events were the reason for withdrawal for one etodolac-treated patient (peripheral edema) and two piroxicam-treated patients (headache, dyspepsia, flatulence, and nausea for one patient and headache for the other). Unsatisfactory response led to the discontinuation of treatment for two patients in the etodolac SR group and three patients in the piroxicam group. There were no clinically significant changes from baseline in vital signs, laboratory values, or urinalysis during the study. These results indicate that both etodolac SR 600 mg and piroxicam 20 mg are effective in the treatment of patients with active rheumatoid arthritis. In addition, the incidence of adverse events reported in the etodolac SR group was low, suggesting that etodolac SR was well tolerated. Although the data for this interim report were obtained from a small number of patients, they suggest good efficacy and tolerability of etodolac SR in the treatment of rheumatoid arthritis.