Comparison of the efficacy and safety of naproxen CR and nabumetone in thetreatment of patients with osteoarthritis of the knee

Objective: To compare the safety and efficacy of naproxen CR (1,000 mg once daily) with that of nabumetone (1,000 mg once daily) in the treatment of p atients with symptomatic knee osteoarthritis (OA). Methods: A total of 159 Korean patients (80 in the naproxen CR group and 79 in the nabumetone group ) were enrolled in this 4-week, single-blind, controlled, randomized, paral lel study and an intention-to-treat model was used for data analysis. Six e fficacy parameters were measured: Lequesne index, visual analogue pain scal e at rest and at activity, patient's and physician's global assessment, and time to walk 50 feet. Results: Significant improvement in all efficacy par ameters except time to walk 50 feet occurred at Week 2 and Week 4 in both g roups. The mean improvement from baseline at Week 2 and Week 4 for the effi cacy variables was not different between naproxen CR and nabumetone group. Twenty-four patients (30%) in the naproxen CR group and 18 patients (22.8%) in the nabumetone group withdrew from the study. Among them, only 1 patien t in the naproxen CR group terminated the study prematurely due to an adver se event of dyspepsia. No statistically significant difference in the frequ ency of adverse events, including gastrointestinal symptoms, was observed b etween these 2 groups during the treatment period. Significant laboratory a bnormalities also did not occur during the study period in both groups. Con clusions: Naproxen CR is an effective and tolerable drug in the treatment o f knee OA. Efficacy and safety profiles are comparable to those of nabumeto ne.