DOUBLE-BLIND COMPARISON OF ETODOLAC SUSTAINED-RELEASE TABLETS AND DICLOFENAC SUSTAINED-RELEASE TABLETS IN PATIENTS WITH RHEUMATOID-ARTHRITIS - AN INTERIM-REPORT

Etodolac SR is the new sustained-release formulation of etodolac, a well-established nonsteroidal anti-inflammatory drug used in the treatment of arthritic conditions. This double-blind, randomized, parallel-group study was conducted in Germany and Italy to compare the efficacy and safety of etodolac SR 600 mg and diclofenac SR 100 mg in patients with active rheumatoid arthritis (RA). The patients met at least five of the American Rheumatism Association diagnostic criteria and were within Steinbroker progression stage I, II, or III and functional class I, II, or III. Active RA was confirmed by at least three of the following four criteria: six or more tender or painful joints on motion, three or more swollen joints, morning stiffness duration of 45 minutes or more, and a Westergren erythrocyte sedimentation rate of 28 mm/hr or longer. In this interim report, 50 patients were randomly assigned to receive etodolac SR and 41 patients received diclofenac SR. Mean age was 58 years (range, 18 to 74 years) in the etodolac SR group and 55 years (range, 26 to 73 years) in the diclofenac group. At baseline, no differences in the demographic characteristics were observed between groups. The results showed no statistically significant differences between groups for any efficacy assessment. Statistically significant improvements from baseline at the final on-therapy visit were observed within each treatment group in the patient and physician overall assessments of the patient's condition, the number of painful joints, and the number of swollen joints. In addition, pain intensity, duration of morning stiffness, average grip strength, time to walk 15 meters, and articular index were all significantly improved. Two patients were withdrawn from the study because of adverse events, one patient in the etodolac SR group because of gastric intolerance and one in the diclofenac SR group because of epigastric postprandial pain. There were no clinically significant changes from baseline in vital signs, laboratory values, or urinalysis. The results of this study indicate that both etodolac SR 600 mg and diclofenac SR 100 mg once daily are effective and safe for the treatment of RA. Both drugs were well tolerated. The new sustained-release formulation of etodolac appears to have good efficacy and tolerability while offering the practical advantage of once-daily dosing.