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.