Local therapy of the knee osteoarthritis: results of a multicenter study of meloxicam

Abstract

Osteoarthritis (OA) is a chronic progressive joint disease that leads to disability. One of the main treatment approaches in OA is to reduce pain and increase the functional activity of patients.Objective: to evaluate the efficacy, tolerability and safety of Meloxicam Canon (MC) in the form of a 1% gel for external use as a symptomatic therapy in patients with knee OA, accompanied by pain.Material and methods. The randomized, open, multicenter study included 100 patients aged 50 to 80 years with stage II–III knee OA, who were randomized into two groups in a 1:1 ratio. In the main group, patients applied MC gel topically, and in the comparison group –Amelotex® gel. Patients were examined at baseline, and after 7, 14 and 28 days. The following indicators were studied: intensity of pain during movement on a visual analogue scale (VAS), affected knee circumference (AKC); Lequesne and WOMAC indices; patient global health assessment (PGHA) according to VAS; response to therapy, tolerability according to the number of adverse reactions (AR), safety according to blood and urine tests.Results and discussion. Pain intensity according to VAS by the end of the observation period decreased on average by 65.0±25.6% in the main group, and by 62.8±29.1% in the comparison group (p<0.0001 for each group). AKS significantly decreased by visit 3 in both groups. There was an improvement in PGHA by VAS by 69.7±24.3 and 66.6±26.8% on average, respectively (p><0.0001 for each group). The average decrease in the Lequesne index was 55.0±30.1 and 52.8±38.3%, and in the WOMAC index – 58.9±30.8 and 59.3±31.8%, respectively, in the main group and comparison group (p><0.0001 in each group for both indices), while there were no differences in the dynamics of all indicators between the two groups (p>0.05). During the observation, no negative dynamics in patients’ condition in both groups was noted. No serious ARs or deaths were recorded during the study.Conclusion. The conducted multicenter study demonstrated that MC gel is an effective and safe drug for local use in OA, accompanied by pain.