Comparative study of the efficacy and safety of Chondroguard® during its combined (intra-articular and intramuscular) and intramuscular injection in patients with knee osteoarthritis

Abstract

Objective: to evaluate the efficacy and safety of Chondroguard® in the combined (intra-articular (IA) + intramuscular (IM)) and IM injection in patients with knee osteoarthritis (OA).Patients and methods. The study enrolled 150 patients with knee OA who were divided into two groups with 75 patients in each group. Group 1 received the drug (100 mg/ml) intramuscularly: 25 injections every other day, the first three injections at a dose of 100 mg, the fourth injection was started with a dose of 200 mg. Group 2 had five IA injections into the target joint at a daily dose of 200 mg with an interval of 3 days between injections, then 16 IM injections at 200 mg every other day. All the patients were prescribed nonsteroidal anti-inflammatory drugs (NSAIDs), such as meloxicam 15 mg. To determine the efficiency of treatment, the investigators estimated the following parameters: pain intensity on a visual analogue scale (VAS), the total WOMAC index and its components (pain, stiffness, and functional insufficiency), sensory and affective-emotional pain characteristics (for the target joint) according to McGill Pain Questionnaire (MPQ) scores. Clinical and biochemical blood tests, clinical urinalysis, coagulogram, and electrocardiography were performed in all the patients at the beginning and the end of the study.Results and discussion. Comparison of two Chondroguard® regimens showed that by the end of treatment, the pain intensity on VAS was significantly lower in Group 2 (IA + IM administration) than in Group 1 (16.81±13.49 and 21.88±13.24, respectively; p<0.0001). Analysis revealed that there were no significant differences between Groups 1 and 2 in the changes of the overall WOMAC index and its components (pain, stiffness, and functional performance), as well as in MPQ pain scores. No serious adverse events (AEs) were recorded in the study. There were 11 AEs in 3.3% (n = 5/150) of the patients throughout the study. By its end, resolution/termination of AEs was noted in 100% of cases. There were no clinically significant pathological laboratory and ECG findings.Conclusion. The test drug during any (IM or combined) route of administration quickly and effectively reduces pain syndrome and stiffness and improves joint functional performance and at the same time it is a safe drug. Its important advantage is a quick effect achieved by IA and IM administration. This makes it possible to reduce the dose of NSAIDs or to discontinue the latter, which is very important for OA patients with comorbidity.

Keywords

• knee osteoarthritis
• chondroguard
• intra-articular injection
• efficacy
• safety
• adverse events