Comparative clinical and economic analysis of the use of symptomatic slow-acting drugs containing glucosamine sulfate in patients with Stage II gonarthrosis during outpatient care
https://doi.org/10.14412/1996-7012-2019-S2-1-8
Abstract
Patients and methods. A retrospective comparative study was conducted using data from medical records of outpatients with GA radiographically classified as Kellgren–Lawrence Stage II. The investigators made cost-effectiveness and budget impact analyses and missed opportunity calculation for pharmacoeconomic examination, by taking into account direct costs and treatment effectiveness on the basis of assessment of the dynamics of pain syndrome, joint functional ability by the Lequesne index, visual analogue scale, WOMAC index, knee joint ultrasound data, and quality of life according to the EuroQol-5D questionnaire. The materials from the medical records of 60 patients with stage II GA were systematized according to the inclusion/exclusion criteria. All the patients were divided into two groups: 1) 30 patients received therapy with intramuscular (IM) Sustaguard® Artro 3 ml thrice weekly; the treatment cycle was 12 injections for 28 days + 1.5-g Sustaguard® Artro powder in a package, dissolved in 200 ml of water, once daily; the treatment cycle was 40 days; the full therapy cycle was 68 days; 2) 30 patients had therapy with IM Dona® 3 ml thrice weekly; the treatment cycle was 12 injections for 28 days + 1.5-g Dona® powder, dissolved in 200 ml of water, once daily; the treatment cycle was 40 days; the full therapy cycle was 68 days. The patients of both groups had a cycle of therapy with a nonsteroidal anti-inflammatory drug (nimesulide) at a dose of 100 mg twice daily for 15 days.
Results and discussion. Sustaguard® Artro treatment for Stage II GA was shown to be more economically feasible in terms of the cost-effectiveness ratio compared to Dona® therapy for 68 days, with the long-term results of treatment being maintained for 2 months after the start of therapy. The effective technology of Sustaguard® Artro therapy makes it possible to save significant budgetary funds (as many as 1.2 million rubles) and to additionally treat 50 patients.
Conclusion. The clinical and economic study has established that the use of Sustaguard® Artro as a treatment for primary GA Stage II is more economically feasible in terms of cost-effectiveness ratio.
About the Authors
I. V. SarvilinaRussian Federation
74, Sotsialisticheskaya St., Build. 3, Rostov-on-Don 344002
Yu. S. Prokofyeva
Russian Federation
Department of Nervous System Diseases, Faculty of Dentistry
20, Delegatskaya St., Build. 1, Moscow 127473
21, Vuchetich St., Moscow 127206
References
1. Reginster JL, Arden NK, Haugen IK, et al. Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a working group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO). Semin Arthritis Rheum. 2018 Aug;48(1):1-8. doi: 10.1016/j.semarthrit.2017.12.003. Epub 2017 Dec 7.
2. Arden N, Nevitt M. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25. doi: 10.1016/j.berh.2005.09.007
3. Nasonova VA, Folomeeva OM. Medical and social significance of the XIII class of diseases for the population of Russia. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2001;39(1):7-11. (In Russ.)
4. Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99. doi: 10.1093/bmb/lds038. Epub 2013 Jan 20.
5. Neogi T, Zhang Y. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 2013 Feb;39(1):1-19. doi: 10.1016/j.rdc.2012.10.004. Epub 2012 Nov 10.
6. Jordan K, Arden N, Doherty M, et al. EULAR Recommendations 2003, an evidence based approach to the management of knee osteoarthritis: report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec; 62(12):1145-55.
7. Woolf A, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
8. Alekseeva LI. Delayed-action drugs in the treatment of OA. Russkii meditsinskii zhurnal. 2012;(7):389-93. (In Russ.)
9. Elovikova ES. Intensity of lipid peroxidation processes in osteoarthritis patients. Al'manakh molodoi nauki. 2010;(3):9-10. (In Russ.)
10. Ishijima M, Watari T, Naito K, et al. Relationships between biomarkers of cartilage, bone, synovial metabolism and knee pain provide insights into the origins of pain in early knee osteoarthritis. Arthritis Res Ther. 2011 Feb 14;13(1):R22. doi: 10.1186/ar3246.
11. 11 Murray CJ, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.
12. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1,160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.
13. Symmons D, Mathers C, Pfleger B. Global burden of osteoarthritis in the year 2000. www.who.int/entity/healthinfo/statistics/bod_osteoarthritis.pdf
14. Mathers C, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442.
15. Fernandes L, Hagen K, Bijlsma J, et al. EULAR Reco mmendations for the Nonpharmacological Core Management of Hip and Knee Osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
16. Lesnyak OM, editor. Klinicheskie rekomendatsii. Osteoartrit. Diagnostika i vedenie bol'nykh osteoartritom kolennykh i tazobedrennykh sustavov [Clinical recommendations. Osteoarthritis. Diagnosis and management of patients with osteoarthritis of the knee and hip joints]. Moscow: GEOTAR-Media; 2006
17. Zaitseva EM, Alekseeva LI, Nasonov EL. Pathogenesis of osteoarthritis and substantiation of the use of strontium ranelate. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2013;51(6):696–702. (In Russ.) doi:10.14412/1995-4484-2013-696-702.
18. Belousov YuB, Lepakhin VK, Kukes VG, Petrov VI, editors. Klinicheskaya farmakologiya. Natsional'noe rukovodstvo [Clinical pharmacology. National guidelines]. Moscow: GEOTAR-Media; 2009.
19. Savelova EE, Maiko OYu. Rational therapy of osteoarthritis on an outpatient basis. Klinitsist. 2012;(3-4):67-72. (In Russ.)
20. Rozendaal RM, Koes BW, van Osch GJ, et al. Effect of glucosamine sulfate on hip osteoarthritis: a randomized trial. Ann Intern Med. 2008 Feb 19;148(4):268-77.
21. Golubev G, Krigshtein O. Molecular pathology of osteoarthritis as a basis for pathogenetically justified structural-modifying therapy. Mezhdunarodnyi zhurnal meditsinskoi praktiki. 2005;(2):30-8. (In Russ.)
22. Setnikar I, Cereda R, Pacini A, et al. Antireactive properties of glucosamine sulfate. rzneimittelforschung. 1991 Feb;41(2): 157-61.
23. McAlindon Т, La Valley M, Gulin J, Felson D. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA. 2000 Mar 15;283(11):1469-75.
24. Towheend ТЕ, Anastassiades TP, Shea B, et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev. 2001;(1):CD002946.
25. Об утверждении отраслевого стандарта «Клинико-экономические исследования. Общие положения»: приказ №163 Министерства Здравоохранения Российской Федерации от 27.05.2011. [On approval of the industry standard «Clinical and economic research. General provisions»: order №163 of the Ministry of Health of the Russian Federation from 27.05.2011].
26. Smirnov AV. Atlas rentgenologicheskoi diagnostiki pervichnogo osteoartroza [Atlas of x-ray diagnosis of primary osteoarthritis]. Moscow: IMA-PRESS; 2010
27. Kellgren JH, Lawrence JS. Radiographic assessment of osteoarthritis. Ann Rheum Dis. 1957 Dec;16(4):494-502.
28. Государственный реестр лекарственных средств. [State register of medicines] http://grls.rosminzdrav.ru
29. https://www.pharmindex.ru
30. http://government.ru/docs/35025/
31. http://rostov-tfoms.ru/dokumenty/normativnaya-baza/tarifnoe-soglashenie
32. Gerasimov VB, Khokhlov AL, Karpov OI, editors. Farmakoekonomika i farmakoepidemiologiya – praktika priemlemykh reshenii [Pharmacoeconomics and pharmacoepidemiology-practice of acceptable solutions]. Moscow: Meditsina; 2005
33. Walley T, Haycox A, Boland A. Pharmacoeconomics. Elsevier Health Sciences; 2004.
Review
For citations:
Sarvilina IV, Prokofyeva YS. Comparative clinical and economic analysis of the use of symptomatic slow-acting drugs containing glucosamine sulfate in patients with Stage II gonarthrosis during outpatient care. Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2019;13(4S). (In Russ.) https://doi.org/10.14412/1996-7012-2019-S2-1-8