N. Bellamy et al., A MULTICENTER STUDY OF TENOXICAM AND DICLOFENAC IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE, Journal of rheumatology, 20(6), 1993, pp. 999-1004
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.