DOUBLE-BLIND, PARALLEL COMPARISON OF ETODOLAC AND NAPROXEN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Etodolac is a nonsteroidal anti-inflammatory drug with potent analgesic and anti-inflammatory properties. The safety and efficacy of etodolac and naproxen, a drug with established efficacy in the treatment of osteoarthritis (OA), were compared in the treatment of patients with OA of the knee. Fifty-six patients were enrolled in this 6-week multicenter, double-blind, parallel trial. The patients received either 300 mg of etodolac twice a day (b.i.d.) or 500 mg of naproxen b.i.d. Analysis of efficacy was based on changes from baseline in 15 variables. Patients in both treatment groups showed prompt response to therapy. The etodolac group had significant improvement from baseline for 10 efficacy variables at week 2, 12 variables at week 4, 13 variables at week 6, and 14 variables at final evaluation. In comparison, the naproxen treatment group showed significant improvement in 13 variables at week 2, 11 at week 4, and 10 at week 6 and the final evaluation. The patient's global evaluation indicated that 69% of the etodolac-treated patients had improvement in their condition over the course of therapy compared with 42% of the naproxen-treated patients. The overall incidence of adverse reactions was comparable for the two treatments; however, the naproxen-treated patients had a significantly higher incidence of dyspepsia. Three patients in the etodolac group and 4 patients in the naproxen group withdrew for adverse reactions. The results of this study indicate that etodolac is comparable to naproxen in relieving the symptoms of OA. Moreover, etodolac produced less gastrointestinal intolerance.