AB0885 EFFECTIVENESS AND SAFETY OF GLUCOSAMINE AND CHONDROITIN COMBINATION IN PATIENTS WITH KNEE AND HIP OSTEOARTHRITIS: INTERIM ANALYSIS RESULTS OF AN OBSERVATIONAL STUDY

Abstract

Background:Combined treatment with oral glucosamine hydrochloride (GH) and chondroitin sulfate (CS) was shown to be efficient for pain relief and function improvement in osteoarthritis patients with moderate to severe knee pain [1,2].Objectives:To investigate demographic and clinical characteristics, changes in pain, functions of daily living, quality of life and treatment satisfaction of patients with knee osteoarthritis (KOA) or hip osteoarthritis (HOA) receiving long-term treatment with oral GH and CS combination in routine clinical practice.Methods:An open-label, multicenter, observational prospective study is being conducted in the Russian Federation. Patients of both sexes with KOA or HOA (Kellgren and Lawrence grades I-III) who receive GH 500 mg+CS 400 mg capsules three times a day for the first 3 weeks of treatment, then twice daily, are included in the study. The interim analysis has been conducted after the first 550 enrolled patients (50% of the total sample size) had completed the first follow-up visit (Week 16-24 after the start of treatment).Results:The study group included 406 (73.8%) patients with KOA and 144 (26.2%) patients with HOA enrolled in 43 centers in Russia. The mean age of the patients was 61.1 years; most patients were women (88.7%). The predominant risk factors for OA were non-genetic causes (excess weight, hormonal disorders, malformations of bones and joints, joint operations) (52.8% of patients), exogenous risk factors (professional activity, trauma, sports) and hereditary diseases of bones and joints were reported in 15.5% and 4.1% of patients, respectively.Interim analysis showed clinically significant improvement in each of the KOOS and HOOS subscales at 4-6 months after the start of treatment. In patients with KOA, the mean score increase was 15.7 for the Pain subscale, 14.6 for the Quality of Life subscale, 13.8 for the Physical function (KOOS-PS), and 11.7 for the Symptoms subscale. The percentage of patients who rated the pain frequency as ‘always’ or ‘daily’ decreased from 60% to 25%.In patients with HOA, the mean score increase was 16.0 for the Pain subscale, 14.3 for the Quality of Life subscale, 16.1 for the Physical function (HOOS-PS), and 10.3 for the Symptoms subscale. The percentage of patients who rated the pain frequency as ‘never’ or ‘monthly’ increased from 34% to 60%.Most patients (89.1%) were receiving the medicinal product for ≥3 months. Treatment-related AEs were reported in 16 (3.0%) patients and mainly included gastrointestinal tract disorders (in 12 (2.2%) patients).Conclusion:The results obtained at 4-6 months after the start of treatment demonstrate clinically significant reduction of frequency and intensity of pain and other OA symptoms, as well as improvement of functions in daily living and quality of life in patients with KOA or HOA after the first course of treatment with GH + CS capsules. The majority of patients (72.5%) were satisfied with the treatment. The incidence of drug-related AEs was low, and the nature of AEs was consistent with known safety profile of GH and CS combination.