563 ASSESSMENT OF THE EFFICACY SAFETY AND TOLERABILITY OF LORNOXICAM SR 16mg Vs LORNOXICAM 8mg IN ADULT PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Abstract

Purpose: A new Diacerein Modified Release (MR) formulation has been developed in India. The present prospective, randomized, double blind, multicentric, comparative study was undertaken to evaluate efficacy, safety and tolerability of Diacerein MR 100mg and conventional Diacerein 50mg in 224 adult patients with Osteoarthritis(OA) of the Knee after approval by the respective institutional ethics committee. Methods: Patients fulfilling selection criteria were treated with Diacerein MR 100mg once daily or Diacerein 50mg twice daily for 8 weeks after obtaining their informed consent. The primary efficacy variables included Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function) and the Visual Analog Scale (VAS) scores (for pain) while the secondary variable included improvement in Patient’s and Physician’s Global Assessment of Arthritis. Results: Seven patients in Diacerein MR and 8 in Diacerein group were lost to follow up. Thus a total 105 patients in Diacerein MR 100mg group and 106 in Diacerein 50mg group were included in the analysis. Results indicated that there was a statistically significant(p<0.05) early reduction in the mean VAS scores, WOMAC-OA pain, stiffness and physical function scores in both the groups at the end of 8 weeks. The reduction in mean total score of WOMAC OA was significantly (P<0.05) greater in Diacerein MR group as compared to Diacerein group at the end of the study. A greater number of patients in Diacerein MR group had good to very good effects of treatment and the difference was statistically significant (P<0.05) as per both patients and physicians global assessment as compared to Diacerein group. The incidence of diarrhea was less in Diacerein MR group compared to Diacerein group. Conclusions: Once-daily Diacerein MR 100 mg was as effective as twice daily Diacerein 50 mg but better tolerated and could be a valuable therapeutic option in patients with osteoarthritis of the knee.