A MULTICENTER, RANDOMIZED, DOUBLE-BLIND-STUDY COMPARING LORNOXICAM WITH DICLOFENAC IN OSTEOARTHRITIS

Objective, To compare the efficacy and tolerability of lornoxicam and diclofenac in the treatment of patients with osteoarthritis (OA) over 12 weeks and to assess the efficacy and tolerability of lornoxicam ove r a followup period of 40 weeks. Methods. In a double blind, parallel group study, 135 patients (mean age 63 years) with OA of the hip and/o r knee were randomized to receive lornoxicam 4 mg 3 times daily (tid), lornoxicam 8 mg twice daily (bid), or diclofenac 50 mg tid for 12 wee ks. 85 patients who completed this 12 week treatment period subsequent ly received lornoxicam 3 mg tid or 8 mg bid for up to 40 weeks. Result s, Over the initial 12 week treatment period, intention-to-treat analy sis revealed improvements in the functional index of severity for OA i n all 3 groups by -1.5 to -1.9 points and pairwise testing demonstrate d significant intergroup equivalence (p < 0.033). Confirmatory analysi s demonstrated the expected efficacy as outlined in the sample size ca lculation. The percentage of patients showing improvements in disease activity (about 36%) and pain intensity (42 to 48%) was also similar a nd a clear majority of patients also reported ''some'' or ''excellent' ' pain relief (80 to 89%). A per protocol analysis produced similar re sults. During the 40 week lornoxicam followup treatment period there w as slight deterioration in the functional index of severity of OA (0.3 to 1.1 points). This minor change may reflect the natural course of t he disease rather than a loss of efficacy in lornoxicam. Disease activ ity and pain intensity continued to improve but in a lesser proportion of patients (< 23%) compared to the previous phase, Nevertheless, a s imilar high percentage of patients (78 to 89%) reported ''some'' or '' excellent'' pain relief. Adverse events in both phases of this study w ere consistent with those commonly reported during treatment with nons teroidal antiinflammatory drugs and included headache and gastrointest inal events. There was no difference in the frequency or severity of a dverse events between any of the treatment groups. Lornoxicam was well tolerated in the long term. Conclusion, Lornoxicam 4 mg tid and 8 mg bid were as effective as diclofenac 50 mg tid for the treatment of OA. There was no significant difference in tolerability of these regimens . Thus, lornoxicam appears to be a useful therapeutic alternative to d iclofenac in patients with OA.