EFFECTIVENESS AND SAFETY OF CHONDROGUARD THERAPY IN PATIENTS WITH ENDOCRINE PHENOTYPE OF OSTEOARTHRITIS
DOI: https://doi.org/10.29296/25877305-2023-06-05
Issue:
6
Year:
2023
Objective. To evaluate the efficiency and safety of therapy with parenteral chondroitin sulfate (CS) Chondroguard®, CS-Bioactive© (Bioiberica S.A.U., Spain); ZAO “Sotex” PharmFirm, Russia) in patients with Stage II knee osteoarthritis (KOA), grade 1 knee functional insufficiency (FI), and type 2 diabetes mellitus (T2DM).
Subjects and methods. A 50-day comparative pilot study involved 80 patients with Kellgren-Lawrence Stage II KOA, grade 1 FI, and T2DM, who were divided into 2 groups; Group 1 (a study group; n=40) received CS (Chondroguard®, 100 mg/ml, intramuscularly, every other day; the first three injections of 1 ml each; if they were well tolerated; starting from injection 4 of ml each; the treatment cycle was 25 injections for 50 days) and therapy for T2DM and its complications; Group 2 (a comparison group; n=40) took oral symptomatic slow acting drugs for osteoarthritis (SYSADOA) agents containing CS, glucosamine, unsaponifiable compounds of avocado and soybean, and therapy for T2DM and its complications. On study days 0 and 50, the investigators calculated in the patients the scores of the visual analogue scale (VAS), WOMAC index, the Lequesne index, those of the WHO and the Narango Therapy Safety Scales, assessed the parameters of the blood hormonal and metabolic profile, free radical oxidation (FRO), antioxidant system (AOS), and the levels of blood proinflammatory factors.
Results. In Group 1, therapy with CS was well tolerated and was accompanied by a reduction in pain intensity on VAS at rest and in motion, in functional restrictions on the WOMAS index and the Lequesne index, as well аs by a decrease in blood proinflammatory markers (С-reactive protein, interleukin 6 and 1β, leptin, lipocalin-2), in the concentration of fasting and postprandial glucose, HbA1c, С-peptide, insulin-like growth factor-1, and in FRO-AOS activity (malondialdehyde, protein oxidative modification, superoxide dismutase) as compared with the indicators in Group 2.
Conclusion. Chondroguard® was shown to be effective and safe in the combination therapy in patients with Stage II endocrine KOA phenotype, grade 1 FI, and T2DM.
Keywords:
herapy
osteoarthritis
diabetes mellitus
endocrine phenotype
chondroitin sulfate
Chondroguard®
disease-modifying osteoarthritis drugs.
References:
- Guariguata L., Whiting D., Hambleton I. et al. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014; 103 (2): 137–49. DOI: 10.1016/j.diabres.2013.11.002
- Vos T., Flaxman A., Naghavi M. et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012; 380 (9859): 2163–96. DOI: 10.1016/s0140-6736(12)61729-2
- Дедов И.И., Шестакова М.В., Викулова О.К. и др. Эпидемиологические характеристики сахарного диабета в Российской Федерации: клинико-статистический анализ по данным регистра сахарного диабета на 01.01.2021. Сахарный диабет. 2021; 24 (3): 204–21 [Dedov I.I., Shestakova M.V., Vikulova O.K. et al. Epidemiological characteristics of diabetes mellitus in the Russian Federation: clinical and statistical analysis according to the Federal diabetes register data of 01.01.2021. Diabetes mellitus. 2021; 24 (3): 204–21 (in Russ.)]. DOI: 10.14341/DM12759
- Lawrence R., Felson D., Helmick C. et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008; 58 (1): 26–35. DOI: 10.1002/art.23176
- Visser A., de Mutsert R., le Cessie S. et al. The relative contribution of mechanical stress and systemic processes in different types of osteoarthritis: the NEO study. Ann Rheum Dis. 2015; 74 (10): 1842–7. DOI: 10.1136/annrheumdis-2013-205012
- Scheen A., Van Gaal L. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014; 2 (11): 911–22. DOI: 10.1016/S2213-8587(14)70004-X
- CDC. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010–2012. MMWR Morb Mortal Wkly Rep. 2013; 62 (44): 869–73.
- Bijlsma J., Berenbaum F., Lafeber F. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011; 377 (9783): 2115–26. DOI: 10.1016/S0140-6736(11)60243-2
- Yusuf E., Nelissen R., Ioan-Facsinay A. et al. Association between weight or body mass index and hand osteoarthritis: a systematic review. Ann Rheum Dis. 2010; 69 (4): 761–5. DOI: 10.1136/ard.2008.106930
- Luo Y., Samuels J., Krasnokutsky S. et al. A low cartilage formation and repair endotype predicts radiographic progression of symptomatic knee osteoarthritis. J Orthop Traumatol. 2021; 22 (1): 10. DOI: 10.1186/s10195-021-00572-0
- Louati K., Vidal C., Berenbaum F. et al. Association between diabetes mellitus and osteoarthritis: systematic literature review and meta-analysis. RMD Open. 2015; 1 (1): e000077. DOI: 10.1136/rmdopen-2015-000077
- Nielen J., Emans P., Dagnelie P. et al. Severity of diabetes mellitus and total hip or knee replacement: a population-based case-control study. Medicine. 2016; 95 (20): e3739. DOI: 10.1097/MD.0000000000003739
- King K., Rosenthal A. The adverse effects of diabetes on osteoarthritis: update on clinical evidence and molecular mechanisms. Osteoarthr Cartil. 2015; 23 (6): 841–50. DOI: 10.1016/j.joca.2015.03.031
- Courties A., Sellam J. Osteoarthritis and type 2 diabetes mellitus: what are the links? Diabetes Res Clin Pract. 2016; 122: 198–206. DOI: 10.1016/j.diabres.2016.10.021
- Courties A., Gualillo O., Berenbaum F. et al. Metabolic stress-induced joint inflammation and osteoarthritis. Osteoarthr Cartil. 2015; 23(11): 1955–65. DOI: 10.1016/j.joca.2015.05.016
- Wang Y., Wluka A., Hodge A. et al. Effect of fatty acids on bone marrow lesions and knee cartilage in healthy, middle-aged subjects without clinical knee osteoarthritis. Osteoarthr Cartil. 2008; 16 (5): 579–83. DOI: 10.1016/j.joca.2007.09.007
- Chen Y., Sheu M., Tsai K. et al. Advanced glycation end products induce peroxisome proliferator-activated receptor gamma down-regulation-related inflammatory signals in human chondrocytes via toll-like receptor-4 and receptor for advanced glycation end products. PLoS One. 2013; 8 (6): e66611. DOI: 10.1371/journal.pone.0066611
- Schramm J., Dinh T., Veves A. Microvascular changes in the diabetic foot. Int J Low Extrem Wounds. 2006; 5 (3): 149–59. DOI: 10.1177/1534734606292281
- Findlay D. Vascular pathology and osteoarthritis. Rheumatology. 2007; 46 (12): 1763–8. DOI: 10.1093/rheumatology/kem191
- Bruyere O., Cooper C., Pelletier J. et al. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014; 44 (3): 253–63. DOI: 10.1016/j.semarthrit.2014.05.014
- ADA. American Diabetes Association. 4. Lifestyle management: standards of medical care in diabetes 2018. Diabetes Care. 2018; 41 (Suppl. 1): S38–50. DOI: 10.2337/dc18-S004
- Shirinsky I., Shirinsky V. Effects of medication-treated diabetes on incidence and progression of knee osteoarthritis: a longitudinal analysis of the osteoarthritis initiative data. Rheumatol Int. 2017; 37 (6): 983–91. DOI: 10.1007/s00296-017-3676-7
- Zhang W., Nuki G., Moskowitz R. et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthr Cartil. 2010; 18 (4): 476–99. DOI: 10.1016/j.joca.2010.01.013
- Machado G., Maher C., Ferreira P. et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ. 2015; 350: h1225. DOI: 10.1136/bmj.h1225
- Dai W., Ye L., Liu A. et al. Prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus: a meta-analysis. Medicine. 2017; 96 (39): e8179. DOI: 10.1097/md.0000000000008179
- Massart J., Begriche K., Moreau C. et al. Role of nonalcoholic fatty liver disease as risk factor for drug-induced hepatotoxicity. J Clin Transl Res. 2017; 3 (Suppl 1): 212–32. DOI: 10.18053/jctres.03.2017S1.006
- Pratt N., Roughead E., Ryan P. et al. Differential impact of NSAIDs on rate of adverse events that require hospitalization in high-risk and general veteran populations: a retrospective cohort study. Drugs Aging. 2010; 27 (1): 63–71. DOI: 10.2165/11531250-000000000-00000
- Fournier J., Sommet A., Durrieu G. et al. Drug interactions between antihypertensive drugs and non-steroidal antiinflammatory agents: a descriptive study using the French Pharmacovigilance database. Fundam Clin Pharmacol. 2014; 28 (2): 230–5. DOI: 10.1111/fcp.12014
- Heyman S., Khamaisi M., Rosen S. et al. Potential hypoxic renal injury in patients with diabetes on SGLT2 inhibitors: caution regarding concomitant use of nsaids and iodinated contrast media. Diabetes Care. 2017; 40 (4): e40–e1. DOI: 10.2337/dc16-2200.
- Reginster J., Deroisy R., Rovati L. et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomised, placebo-controlled clinical trial. Lancet. 2001; 357 (9252): 251–6. DOI: 10.1016/S0140-6736(00)03610-2
- Kahan A., Uebelhart D., De Vathaire F. et al. Long-term effects of chondroitins 4 and 6 sulfate on knee osteoarthritis: the study on osteoarthritis progression prevention, a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2009; 60 (2): 524–33. DOI: 10.1002/art.24255
- Торшин И.Ю., Лила А.М., Наумов А.В. и др. Метаанализ клинических исследований эффективности лечения остеоартрита препаратом Хондрогард. ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология. 2020; 13 (4): 388–99 [Torshin I.Yu., Lila A.M., Naumov A.V. et al. Meta-analysis of clinical trials of osteoarthritis treatment effectiveness with Chondroguard. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2020; 13 (4): 388–99 (in Russ.)]. DOI: 10.17749/2070-4909/farmakoekonomika.2020.066
- Towheed T., Maxwell L., Anastassiades T. et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev. 2009; 2: CD002946. DOI: 10.1002/14651858.CD002946.pub2
- Martel-Pelletier J. Diacerein-containing products: same risk of diarrhoea? Aging Clin Exp Res. 2018; 30 (4): 411–2. DOI: 10.1007/s40520-018-0911-3
- Olivier P., Montastruc J. Post-marketing safety profile of avocado-soybean unsaponifiables. Presse Med. 2010; 39 (10): e211–6. DOI: 10.1016/j.lpm.2010.01.013
- Choudhry M., Malik R., Charalambous C. Blood glucose levels following intra-articular steroid injections in patients with diabetes: a systematic review. JBJS Rev. 2016; 4 (3): e5. DOI: 10.2106/JBJS.RVW.O.00029
- Cooper C., Bardin T., Brandi M.-L. et al. Balancing benefits and risks of glucocorticoids in rheumatic diseases and other inflammatory joint disorders: new insights from emerging data. An expert consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Aging Clin Exp Res. 2016; 28 (1): 1–16. DOI: 10.1007/s40520-015-0522-1
- Cooper C., Rannou F., Richette P. et al. Use of intraarticular hyaluronic acid in the management of knee osteoarthritis in clinical practice. Arthritis Care Res. 2017; 69 (9): 1287–96. DOI: 10.1002/acr.23204
- Гонартроз. Клинические рекомендации [Gonartroz. Klinicheskie rekomendatsii (in Russ.)]. URL: https://cr.minzdrav.gov.ru/recomend/667_1
- Kolasinski S.L., Neogi T., Hochberg M.C. et al. 2019 American College of Rheumatology / Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020; 72 (2): 149–62. DOI: 10.1002/acr.24131
- Дедов И.И., Шестакова М.В., Майоров А.Ю. и др. Сахарный диабет 2 типа у взрослых. Сахарный диабет. 2020; 23 (2S): 4–102 [Dedov I.I., Shestakova M.V., Mayorov A.Y. et al. Diabetes mellitus type 2 in adults. Diabetes mellitus. 2020; 23 (2S): 4–102 (in Russ.)]. DOI: 10.14341/DM12507
- Коробейникова Э.Н. Модификация определения продуктов перекисного окисления липидов в реакции с тиобарбитуровой кислотой. Лабораторное дело. 1989; 7: 8–10 [Korobeinikova E.N. Modifikatsiya opredeleniya produktov perekisnogo okisleniya lipidov v reaktsii s tiobarbiturovoi kislotoi. Labоratornoe delo. 1989; 7: 8–10 (in Russ.)].
- Дубинина Е.Е., Сальникова Л.А., Ефимова Л.Ф. Активность и изоферментный спектр СОД эритроцитов в плазме крови человека. Лабораторное дело. 1983; 10: 30–3 [Dubinina E.E., Sal'nikova L.A., Efimova L.F. Aktivnost' i izofermentnyj spektr SOD eritrocitov v plazme krovi cheloveka. Labоratornoe delo. 1983; 10: 30–3 (in Russ.)].
- Дубинина Е.Е. Продукты метаболизма кислорода в функциональной активности клеток (жизнь и смерть, созидание и разрушение). Физиологические и клиникобиохимические аспекты. СПб: Медицинская пресса, 2006; 400 с. [Dubinina E.E. Produkty metabolizma kisloroda v funkcional'noj aktivnosti kletok (zhizn' i smert', sozidanie i razrushenie). Fiziologicheskie i klinikobiohimicheskie aspekty. SPb: Medicinskaya pressa, 2006; 400 р. (in Russ.)].
- Reginster J.-Y., Veronese N. Highly purified chondroitin sulfate: a literature review on clinical efficacy and pharmacoeconomic aspects in osteoarthritis treatment. Aging Clin Exp Res. 2021; 33 (1): 37–47. DOI: 10.1007/s40520-020-01643-8
- Mobasheri A., Neama G., Bell S. et al. Human articular chondrocytes express three facilitative glucose transporter isoforms: GLUT1, GLUT3 and GLUT9. Cell Biol Int. 2002; 26 (3): 297–300. DOI: 10.1006/cbir.2001.0850
- Rosa S., Goncalves J., Judas F. et al. Impaired glucose transporter-1 degradation and increased glucose transport and oxidative stress in response to high glucose in chondrocytes from osteoarthritic versus normal human cartilage. Arthritis Res Ther. 2009; 11 (3): R80. DOI: 10.1186/ar2713
- Davies-Tuck M., Wang Y., Wluka A. et al. Increased fasting serum glucose concentration is associated with adverse knee structural changes in adults with no knee symptoms and diabetes. Maturitas. 2012; 72 (4): 373–8. DOI: 10.1016/j.maturitas.2012.05.013
- Franke S., Ruster C., Pester J. et al. Advanced glycation end products affect growth and function of osteoblasts. Clin Exp Rheumatol. 2011; 29 (4): 650–60.
- Tsai C., Chiang Y., Chen H. et al. High glucose induces vascular endothelial growth factor production in human synovial fibroblasts through reactive oxygen species generation. Biochim Biophys Acta. 2013; 1830 (3): 2649–58. DOI: 10.1016/j.bbagen.2012.12.017
- Rosa S., Rufino A., Judas F. et al. Expression and function of the insulin receptor in normal and osteoarthritic human chondrocytes: modulation of anabolic gene expression, glucose transport and GLUT-1 content by insulin. Osteoarthr Cartil. 2011; 19 (6): 719–27. DOI: 10.1016/j.joca.2011.02.004
- Ribeiro M., Lopez de Figueroa P., Blanco F. et al. Insulin decreases autophagy and leads to cartilage degradation. Osteoarthr Cartil. 2016; 24 (4): 731–9. DOI: 10.1016/j.joca.2015.10.017
- Martel-Pelletier J., Raynauld J.-P., Mineau F. et al. Levels of serum biomarkers from a two year multicentre trial are associated with treatment response on knee osteoarthritis cartilage loss as assessed by magnetic resonance imaging: an exploratory study. Arthritis Res Ther. 2017; 19: 169. DOI: 10.1186/s13075-017-1377-y
- Mertens M., Singh J. Biomarkers in Arthroplasty: A Systematic Review. Open Orthop J. 2011; 5: 92–105. DOI: 10.2174/1874325001105010092
- Vincent T. IL-1 in osteoarthritis: time for a critical review of the literature. F1000Research. 2019; 8 (F1000 Faculty Rev): 934. DOI: 10.12688/f1000research.18831.1
- Gupta K., Shukla M., Cowland J. et al. Neutrophil gelatinase-associated lipocalin is expressed in osteoarthritis and forms a complex with matrix metalloproteinase 9. Arthritis Rheum. 2007; 56 (10): 3326–35. doi:10.1002/art.22879