A DOUBLE-BLIND COMPARISON OF THE EFFICACY AND SAFETY OF KETOPROFEN EXTENDED-RELEASE (200 MG ONCE-DAILY) AND DICLOFENAC (75 MG TWICE-DAILY) FOR TREATMENT OF OSTEOARTHRITIS

The therapeutic efficacy and safety of ketoprofen extended-release (ER) and diclofenac were compared in a multicenter, randomized, double-blind, parallel-group study of 239 patients with active osteoarthritis of the hip and/or knee. Patients were treated for up to 4 months: 118 received ketoprofen ER, 200 mg once daily, and 121 patients received diclofenac, 75 mg twice daily. The demographic attributes of the two study groups were comparable. Clinical efficacy and safety assessments were made at weeks 1, 2, and 4, and at months 2, 3, and 4. The efficacy analysis included 230 patients: 114 in the ketoprofen ER group and 116 in the diclofenac group. Both treatments produced significant (P < 0.001) improvement from baseline in all efficacy variables at all time points. Except for nighttime pain/sleep disturbance at month 2 and patient's global assessment at week 2, there were no clinically significant differences between treatments. Ketoprofen ER and diclofenac produced rapid symptomatic relief (statistically significant at week 1), which was maintained over the 4-month treatment period. The rates of common treatment-emergent study events were similar in both groups; however, constipation and fever were more frequent with ketoprofen ER and liver test abnormalities were more frequent with diclofenac. Of the 29 patients who withdrew because of adverse study events, 10 were treated with ketoprofen ER (most had minor gastrointestinal events) and 19 were treated with diclofenac (many had increased transaminase activities). A duodenal ulcer was diagnosed in one diclofenac-treated patient at month 4. Fourteen diclofenac-treated patients had potentially clinically significant elevations in serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase activities (>3 times the upper limit of the normal range). Ketoprofen ER and diclofenac were therapeutically equivalent in this study, but clinically significant signs of potential hepatotoxicity were seen only in the diclofenac-treated group.