A MULTICENTER STUDY OF TENOXICAM AND DICLOFENAC IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Objective. To conduct the first Canadian study of the comparative effi cacy and safety of tenoxicam and diclofenac in patients with primary o steoarthritis (OA) of the knee. Methods. Tenoxicam 20 mg per os once d aily (po od) was compared to diclofenac (Voltaren(TM)) 50 mg per os 3 times a day (po tid) in a 12-week, double blind, randomized, controlle d, multicenter, parallel trial. The primary outcome measure was the pa in dimension of the WOMAC OA Index. Following an initial screening vis it and a 3 to 7 day NSAID-free washout period (i.e., baseline), patien ts were assessed at Weeks 2, 4 and 12, assessments including some 15 e fficacy variables and safety variables. Results. Ninety-eight patients [tenoxicam (n = 48), diclofenac (n = 50)] participated in the trial. Statistically significant (p less-than-or-equal-to 0.05) improvements in all 3 dimensions of the WOMAC OA Index and six efficacy variables w ere noted in both treatment groups. No significant between drug differ ences were noted on any efficacy variable. Significantly fewer patient s reported adverse events in the tenoxicam group (21 vs 33, p = 0.03). Conclusion. Tenoxicam is efficacious and well tolerated in patients w ith OA of the knee. In this group of patients it was similar in effica cy and superior in tolerability to diclofenac 150 mg/day (50 mg tid). Thus the benefit/risk ratio of tenoxicam was superior to that of diclo fenac in this study.