Controlled-release naproxen compared with isoxicam in patients with osteoarthritis.
The therapeutic efficacy and tolerability of a new controlled-release 1000 mg tablet of naproxen (naproxen CR) were compared with 200 mg isoxicam in 100 out-patients with osteoarthritis. Medications were administered once daily for 4 weeks in a controlled, randomized, double-blind, parallel trial. Patients were assessed for duration of stiffness, global pain, pain in the worst affected joint, night pain, pain on full passive movement, and pain on selected activity. No statistically significant differences were found between naproxen CR and isoxicam for any of the efficacy variables. Only 3 patients (2 with naproxen CR, 1 with isoxicam) reported adverse events, all mild to moderate; no patient withdrew from the study. At the conclusion of the study, patients and physician evaluated therapeutic response independently; both drugs provided steady improvement as judged by patients and physician. Both physician and patients evaluated naproxen CR as very good or good for 36 (72%) patients, and isoxicam as good or very good for 35 (73%) patients. Naproxen CR and isoxicam proved equally effective and well-tolerated for the treatment of osteoarthritis in this study.