A 6-month, double-blind study comparing nabumetone to naproxen in the treatment of osteoarthritis.

A 6-month, double-blind, controlled, randomized, parallel study was performed to compare the efficacy and tolerance of nabumetone (1000 mg at bedtime) with naproxen (250 mg twice daily) in the treatment of osteoarthritis. Five efficacy parameters were evaluated: patient's assessment of overall osteoarthritis activity and pain, physician's assessment of overall osteoarthritis activity and pain, and physician's assessment of pain with respect to a defined activity. All 40 patients entered (20 in each group) were available for evaluation of tolerance and 36 patients for efficacy analysis (18 in each group). The efficacy results revealed significant improvement in all five parameters for each medication except measurement of pain with respect to a defined activity for naproxen (p less than 0.07). The frequency of possible or probable drug-related adverse experiences was high for both drugs. However, only 1 patient left the study because of a probable drug-related adverse experience (abdominal pain in a nabumetone patient). Six nabumetone and 4 naproxen patients dropped out of the study because of lack of efficacy. The results indicate that nabumetone and naproxen have comparable efficacy and tolerance at the dosage used, and suggest that a single night-time dosage of nabumetone may be a convenient and useful treatment for osteoarthritis.