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

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. 

1. Arden N, Nevit MC. Osteoarthritis: Epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25.

2. Галушко ЕА. Медико-социальная значимость ревматических заболеваний. Автореф. дисс. докт. мед. наук. Москва; 2011. [Galushko EA. Medical and social significance of rheumatic diseases. Autoref. diss. doct. med. sci. Moscow; 2011.]

3. Sangha O. Epidemiology of rheumatic disease. Rheumatology (Oxford). 2000 Dec;39 Suppl 2:3-12.

4. Laurent TC, Laurent UB, Fraser JR. The structure and function of hyaluronan: An overview. Immunol Cell Biol. 1996 Apr;74(2):A1-7.

5. Bland JH, Cooper SM. Osteoarthritis: a review of the cell biology involved and evidence for reversibility. Management rationally related to known genesis and pathophysiology. Semin Arthritis Rheum. 1984 Nov;14(2): 106-33.

6. Ward PD, Thibeault SL, Gray SD. Hyaluronic acid: its role in voce. J Voice. 2002 Sep;16(3):303-9.

7. Стребкова ЕА, Соловьева ИВ, Шарапова ЕП и др. Оценка эффективности медикаментозной и немедикаментозной терапии ожирения у больных остеоартрозом коленных суставов. Тезисы VI Съезда ревматологов России. Москва; 2013. С. 152-3. [Strebkova EA, Solov'eva IV, Sharapova EP, et al. Evaluation of the effectiveness of drug and non-drug therapy of obesity in patients with osteoarthritis of the knee. Tezisy VI S"ezda revmatologov Rossii. Moscow; 2013. P. 152-3.]

8. Goldriring MB. The role of the chondrocyte in osteoarthritis. Arthritis Rheum. 2000 Sep;43(9):1916-26.

9. Alaaeddine N, Olee T, Hashimoto S, et al. Production of the chemokine RANTES by articular chondrocytes and role in cartilage degradation. Arthritis Rheum. 2001 Jul;44(7): 1633-43.

10. Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21.

11. Calamia V, Mateos J, Fernandez-Puente P, et al. A pharmacoproteomic study confirms the synergistic effect of chondroitin sulfate and glucosamine. Sci Rep. 2014 Jun 10;4: 5069. doi: 10.1038/srep05069.

12. Lambert C, Mathy-Hartert M, Dubuc JE, et al. Characterization of synovial angiogenesis in osteoarthritis patients and its modulation by chondroitin sulfate. Arthritis Res Ther. 2012 Mar 12;14(2):R58. doi: 10.1186/ar3771.

13. Tat SK, Pelletier JP, Verges J, et al. Chondroitin and glucosamine sulfate in combination decrease the pro-resorptive properties of human osteoarthritis subchondral bone osteoblasts: a basic science study. Arthritis Res Ther. 2007;9(6):R117.

14. Leeb BF, Schweitzer H, Montag K, Smolen JS. A meta-analysis of chondroitin sulfate in the treatment of osteoarthritis. Osteoarthritis Cartilage. 1999;7(Suppl A):130.

15. Eugenio-Sarmiento RM, Vanapat DH, Salido EJ. The efficacy of chondroitinsulfate in the treatment of knee osteoarthritis: a meta-analysis. Osteoarthritis Cartilage. 1999;7(Suppl A):139.

16. Schneider H. Sympptom-Modifying Effect of Chondroitin Sulfate in Knee Osteoarthritis: A Meta-Analysis of Randomized Placebo-Controlled Trials Performed with Structum. Open Rheumatol J. 2012;6:183-9. doi: 10.2174/187431290 1206010183. Epub 2012 Jul 25.

17. Singh JA, Noorbaloochi S, MacDonald R, Maxwell LJ. Chondroitin for osteoarthritis (Rewiew). Cochrane Database Syst Rev. 2015 Jan 28;1:CD005614. doi: 10.1002/14651858. CD005614.pub2.

18. Henrotin Y, Marty M, Mobasheri A. What is the current status of chondroitin sulfate and glucosamine for the treatment of knee osteoarthritis? Maturitas. 2014 Jul; 78(3):184-7. doi: 10.1016/j.maturitas. 2014.04.015. Epub 2014 May 1.

19. Lee YH. Chondroitin sulfate is superior to placebo in symptomatic kneeosteoarthritis. Ann Rheum Dis. 2017 Oct 9. pii: annrheumdis2017-212452. doi: 10.1136/annrheumdis2017-212452. [Epub ahead of print].

20. Алексеева ЛИ, Архангельская ГС, Давыдова АФ и др. Отдаленные результаты применения структума (по материалам многоцентрового исследования). Терапевтический архив. 2003;(9):82-6. [Alekseeva LI, Arkhangel'skaya GS, Davydova AF, et al. Long-term results of the use of structum (on materials of a multicenter study). Terapevticheskii arkhiv. 2003;(9):82-6. (In Russ.)].

21. Алексеева ЛИ, Аникин СГ, Шарапова ЕП и др. Исследование эффективности, переносимости и безопасности препарата Хондрогард у пациентов с остеоартрозом. Русский медицинский журнал. 2013;(32):1624-7. [Alekseeva LI, Anikin SG, Sharapova EP, et al. Study of the efficacy, tolerance and safety of Chondrogard in patients with osteoarthritis. Russkii meditsinskii zhurnal. 2013;(32):1624-7. (In Russ.)].

22. Шарапова ЕП, Алексеева ЛИ, Кашеварова НГ и др. Оценка эффективности, переносимости и безопасности хондрогарда у больных остеоартрозом коленных суставов и коморбидностью. Научно-практическая ревматология. 2017;55(Прил 1); 138. [Sharapova EP, Alekseeva LI, Kashevarova NG, et al. Evaluation of the effectiveness, tolerability and safety chondrogard in patients with osteoarthritis of the knee joints and comorbidity. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2017;55(Suppl 1);138.]