Сравнительный анализ эффективности препаратов для лечения ранних нарушений углеводного обмена (предиабета)
Сравнительный анализ эффективности препаратов для лечения ранних нарушений углеводного обмена (предиабета)
Мкртумян А.М. Сравнительный анализ эффективности препаратов для лечения ранних нарушений углеводного обмена (предиабета). Терапевтический архив. 2024;96(4):419–428.
DOI: 10.26442/00403660.2024.04.202709
Mkrtumyan AM. Comparative analysis of the drugs efficacy for carbohydrate metabolism early disorders (prediabetes) treatment: A review. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(4):419–428.
DOI: 10.26442/00403660.2024.04.202709
Сравнительный анализ эффективности препаратов для лечения ранних нарушений углеводного обмена (предиабета)
Мкртумян А.М. Сравнительный анализ эффективности препаратов для лечения ранних нарушений углеводного обмена (предиабета). Терапевтический архив. 2024;96(4):419–428.
DOI: 10.26442/00403660.2024.04.202709
Mkrtumyan AM. Comparative analysis of the drugs efficacy for carbohydrate metabolism early disorders (prediabetes) treatment: A review. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(4):419–428.
DOI: 10.26442/00403660.2024.04.202709
В современных реалиях фармакологическая коррекция ранних нарушений углеводного обмена выступает основным методом профилактики развития сахарного диабета 2-го типа. Принимая во внимание ведущую роль инсулинорезистентности в развитии предиабета, можно предположить, что препараты, напрямую воздействующие на инсулиновый рецептор, представляют собой средства патогенетической терапии ранних нарушений углеводного обмена, в частности нарушенной толерантности к глюкозе (НТГ). Таким препаратом является Субетта® – представитель класса биологических лекарственных препаратов, созданных на основе градуальной технологии. Учитывая отсутствие в настоящее время прямых сравнительных исследований влияния метформина и препарата Субетта® на риск развития сахарного диабета 2-го типа у пациентов с предиабетом, методом скорректированного непрямого сравнения результатов двойного слепого плацебо-контролируемого рандомизированного клинического исследования выполнен анализ эффективности и безопасности Субетта® у пациентов с НТГ с результатами ряда исследований метформина, аналогичных по критериям включения и эффективности. Полученные результаты свидетельствуют о бÓльшей эффективности препарата Субетта® в терапии НТГ, а метформина – в лечении нарушенной гликемии натощак, что обусловлено различиями в механизмах действия рассматриваемых препаратов, используемых в лечении предиабета.
Ключевые слова: предиабет, ранние нарушения углеводного обмена, нарушение толерантности к глюкозе, сахарный диабет 2-го типа, инсулинорезистентность, Субетта®, метформин
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In the contemporary reality pharmacological correction of the early carbohydrate metabolism disorders is the main method for the type 2 diabetes prevention. Taking into account the main role of insulin resistance in the prediabetes development it can be supposed that pharmacological agents directly activating the insulin receptor are the pathogenic-base therapy for prediabetes treatment. Such kind of this pathogenic therapy is Subetta® – a representative of the class of biological drugs created using the based graduated technology. Due to the absent of the direct comparative trials of Subetta® versus metformin in the efficacy of the type 2 diabetes prevention in prediabetes patients, was performed an analysis of the effectiveness of these two drugs using the adjusted indirect comparison method of the results of the randomized double-blind placebo-controlled clinical trial of Subetta® efficacy and safety in impaired glucose tolerance patients with the results of several metformin studies similar in inclusion and efficacy criteria. The results indicate greater Subetta® efficacy in the treatment of glucose intolerance and metformin's – in the impaired fasting glucose treatment, which can be explained by the differences in the action mechanisms of these two drugs for prediabetes treatment.
Keywords: prediabetes, carbohydrate metabolism early disorders, impaired glucose tolerance, type 2 diabetes mellitus, insulin resistance, Subetta®, metformin
1. Дедов И.И., Шестакова М.В., Галстян Г.Р. Распространенность сахарного диабета 2 типа у взрослого населения России (исследование NATION). Сахарный диабет. 2016;19(2):104-12 [Dedov II, Shestakova MV, Galstyan GR. The prevalence of type 2 diabetes mellitus in the adult population of Russia (NATION study). Diabetes Mellitus. 2016;19(2):104-12 (in Russian)]. DOI:10.14341/DM2004116-17
2. Tabák AG, Herder C, Rathmann W, et al. Prediabetes: a high-risk state for diabetes development. Lancet. 2012;379(9833):2279-90. DOI:10.1016/S0140-6736(12)60283-9
3. Souza CF, Gross JL, Gerchman F, Leitão CB. Pré-diabetes: diagnóstico, avaliação de complicações crônicas e tratamento. Arq Bras Endocrinol Metabol. 2012;56(5):275-84. DOI:10.1590/s0004-27302012000500001
4. Heianza Y, Arase Y, Fujihara K, et al. Screening for pre-diabetes to predict future diabetes using various cut-off points for HbA(1c) and impaired fasting glucose: the Toranomon Hospital Health Management Center Study 4 (TOPICS 4). Diabet Med. 2012;29(9):e279-85. DOI:10.1111/j.1464-5491.2012.03686.x
5. Mando R, Waheed M, Michel A, et al. Prediabetes as a risk factor for major adverse cardiovascular events. Ann Med. 2021;53(1):2090-8. DOI:10.1080/07853890.2021.2000633
6. Hostalek U. Global epidemiology of prediabetes – present and future perspectives. Clin Diabetes Endocrinol. 2019;5:5. DOI:10.1186/s40842-019-0080-0
7. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403. DOI:10.1056/NEJMoa012512
8. Lee CC, Perkins BA, Kayaniyil S, et al. Peripheral Neuropathy and Nerve Dysfunction in Individuals at High Risk for Type 2 Diabetes: The PROMISE Cohort. Diabetes Care. 2015;38(5):793-800. DOI:10.2337/dc14-2585
9. Huang Y, Cai X, Mai W, et al. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016;355:i5953. DOI:10.1136/bmj.i5953
10. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE study group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative analysis оf Diagnostic criteria in Europe. Lancet. 1999;354(9179):617-21.
11. Аметов А.С. Современные аспекты патогенеза сахарного диабета 2 типа: β-клетка, что с тобой? Эндокринология: новости, мнения, обучение. 2022;11(4):8-20 [Ametov AS. Modern aspects of type 2 diabetes mellitus pathogenesis: β-cell, what's wrong with you? Endocrinology: News, Opinions, Training. 2022;11(4):8-20 (in Russian)].
DOI:10.33029/2304-9529-2022-11-4-8-20
12. International diabetes federation: IDF diabetes atlas. 10th edition, 2021. Available at: https://diabetesatlas.org/data/en. Accessed: 25.02.2024.
13. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под ред. И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. Вып. 11. М. 2023 [Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. Pod red. II Dedova, MV Shestakovoi, AIu Maiorova. Vyp. 11. Moscow. 2023 (in Russian)]. DOI:10.14341/DM13042
14. Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003;26(3):725-31. DOI:10.2337/diacare.26.3.725
15. Мисникова И.В., Древаль А.В., Дзебисашвили Т.Г. Выявление группы риска развития сахарного диабета 2-го типа на основе заполнения опросника FINDRISС. Альманах клинической медицины. 2015;(1):46-50 [Misnikova IV, Dreval' AV, Dzebisashvili TG. Identification of risk groups for type 2 diabetes mellitus based on findrisс questionnaire. Almanac of Clinical Medicine. 2015;(1):46-50 (in Russian)]. DOI:10.18786/2072-0505-2015-1-46-50
16. Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677-86. DOI:10.1016/S0140-6736(09)61457-4
17. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015;3(11):866-75. DOI:10.1016/S2213-8587(15)00291-0
18. Tuomilehto J, Lindström J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(18):1343-50. DOI:10.1056/NEJM200105033441801
19. Lindström J, Ilanne-Parikka P, Peltonen M, et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006;368(9548):1673-9. DOI:10.1016/S0140-6736(06)69701-8
20. Li G, Zhang P, Wang J, et al. Cardiovascular mortality, all-cause mortality, and diabetes incidence after lifestyle intervention for people with impaired glucose tolerance in the Da Qing Diabetes Prevention Study: a 23-year follow-up study. Lancet Diabetes Endocrinol. 2014;2(6):474-80. DOI:10.1016/S2213-8587(14)70057-9
21. Gong Q, Zhang P, Wang J, et al. Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study. Lancet Diabetes Endocrinol. 2019;7(6):452-61. DOI:10.1016/S2213-8587(19)30093-2
22. Мкртумян А.М., Егшатян Л.В. Субетта® – новый активатор рецептора инсулина. Эффективная фармакотерапия. 2019;15(12):12-7 [Mkrtumyan AM, Egshatyan LV. Subetta – a New Activator of the Insulin Receptor. Effective Pharmacotherapy. 2019;15(12):12-7 (in Russian)]. DOI:10.33978/2307-3586-2019-15-12-12-17
23. Аметов А.С., Демидова Т.Ю., Мкртумян А.М., и др. Вызов современной эндокринологии: поиски комбинированной терапии в условиях инсулинорезистентности (лекция). Эндокринология: новости, мнения, обучение. 2020;9(1):60-9 [Ametov AS, Demidova TYu, Mkrtumyan AM, et al. Challenge in modern endocrinology: search for combined treatment on the back of insulin resistance (lecture). Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2020;9(1):60-9 (in Russian)]. DOI:10.33029/2304-9529-2020-9-1-60-69
24. Stumvoll M, Häring HU. Glitazones: clinical effects and molecular mechanisms. Ann Med. 2002;34(3):217-24.
25. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-71. DOI:10.1056/NEJMoa072761
26. WHO Pharmaceuticals Newsletter. Pharmaceutical Journal. 1999;3(4). Available at: https://www.researchgate.net/publication/316554424. Accessed: 25.02.2024.
27. Parke-Davis. Letter to Healthcare Professionals. 1998. 28 July. Available at: https://www.researchgate.net/publication/316554424. Accessed: 25.02.2024.
28. Переверзев А.П., Остроумова О.Д., Кочетков А.И. Холестатический вариант лекарственно-индуцированного поражения печени. Качественная клиническая практика. 2020;3:61-74 [Pereverzev AP, Ostroumova OD, Kochetkov AI. Drug-induced liver damage with cholestasis. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice.
2020;(3):61-74 (in Russian)]. DOI:10.37489/2588-0519-2020-3-61-74
29. Cañás M. Troglitazona retiro del mercado. 2000. Available at: https://www.researchgate.net/publication/316554424_Troglitazona_retiro_del_mercado. Accessed: 25.02.2024.
30. ElSayed NA, Aleppo G, Aroda VR, et al. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023. Diabetes Care.
2023;46(Suppl. 1):S41-8. DOI:10.2337/dc23-S003
31. Аметов А.С., Прудникова М.А. Метформин пролонгированного высвобождения – новый стандарт лечения сахарного диабета 2 типа. Эндокринология: новости, мнения, обучение. 2015;1:19-26 [Ametov AS, Prudnikova MA. Metformin prolonged release – a new standard for the treatment of type 2 diabetes. Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2015;1:19-26 (in Russian)].
32. Ratner RE, Christophi CA, Metzger BE, et al. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008;93(12):4774-9. DOI:10.1210/jc.2008-0772
33. Diabetes Prevention Program Research Group. Long-term Effects of Metformin on Diabetes Prevention: Identification of Subgroups That Benefited Most in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2019;42(4):601-8. DOI:10.2337/dc18-1970
34. Аметов А.С., Барыкина И.Н., Бондарь И.А., и др. Приверженность пациентов терапии метформином пролонгированного действия (Глюкофаж® Лонг) в условиях реальной клинической практики в Российской Федерации. Эндокринология: новости, мнения, обучение. 2017;4:52-63 [Ametov AS, Barykina IN, Bondar IA, et al. Adherence of patients to the metformin therapy with prolonged action (Glucophage® long) in real clinical practice in the Russian Federation. Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2017;4:52-63 (in Russian)]. DOI:10.24411/2304-9529-2017-00054
35. Garber AJ, Handelsman Y, Grunberger G, et al. Сonsensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2020 executive summary. Endocr Pract. 2020;26(1):107-39. DOI:10.4158/CS-2019-0472
36. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359(9323):2072-7.
DOI:10.1016/S0140-6736(02)08905-5
37. Биологические лекарственные препараты, полученные на основе градуальной технологии. Общая фармакопейная статья №ОФС.1.7.0001. Дата введения 01.09.2023. Режим доступа: https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-9/biologicheskie-lekarstvennye-preparat.... Ссылка активна на 25.02.2024 [Biologicheskie lekarstvennye preparaty, poluchennye na osnove gradual'noi tekhnologii. Obshchaia farmakopeinaia stat'ia №OFS.1.7.0001. Data vvedeniia 01.09.2023. Available at: https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-9/biologicheskie-lekarstvennye-preparat.... Accessed: 25.02.2024 (in Russian)].
38. Nicoll J, Gorbunov EA, Tarasov SA, Epstein OI. Subetta treatment increases adiponectin secretion by mature human adipocytes in vitro. Int J Endocrinol. 2013;2013:925874. DOI:10.1155/2013/925874
39. Ouedraogo R, Wu X, Xu SQ, et al. Adiponectin suppression of high-glucose-induced reactive oxygen species in vascular endothelial cells: evidence for involvement of a cAMP signaling pathway. Diabetes. 2006;55(6):1840-6. DOI:10.2337/db05-1174
40. Goldstein BJ, Scalia RG, Ma XL. Protective vascular and myocardial effects of adiponectin. Nat Clin Pract Cardiovasc Med. 2009;6(1):27-35. DOI:10.1038/ncpcardio1398
41. Tao L, Gao E, Jiao X, et al. Adiponectin cardioprotection after myocardial ischemia/reperfusion involves the reduction of oxidative/nitrative stress. Circulation. 2007;115(11):1408-16. DOI:10.1161/CIRCULATIONAHA.106.666941
42. Gorbunov EA, Nicoll J, Kachaeva EV, et al. Subetta increases phosphorylation of insulin receptor β-subunit alone and in the presence of insulin. Nutr Diabetes. 2015;5(7):e169. DOI:10.1038/nutd.2015.20
43. Gorbunov EA, Nicoll J, Myslivets AA, et al. Subetta Enhances Sensitivity of Human Muscle Cells to Insulin. Bull Exp Biol Med. 2015;159(4):463-5. DOI:10.1007/s10517-015-2992-8
44. Mkrtumyan A, Ametov A, Demidova T, et al. A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta. J Clin Med. 2022;11(5). DOI:10.3390/jcm11051390
45. Мкртумян Ф.М., Воробьев С.В., Волкова А.Р., Ворохобина Н.В. Влияние препарата Субетта на гликемический контроль у пациентов с сахарным диабетом 2 типа: результаты многоцентрового двойного слепого плацебо-контролируемого рандомизированного клинического исследования. Фарматека. 2020;27(12):38-48 [Mkrtumyan AM, Vorobyev SV, Volkova AR, Vorokhobina NV. Effects of Subetta® on glycemic control in patients with type 2 diabetes mellitus: results of a multicenter, double-blind, placebo-controlled, randomized clinical study. Farmateka. 2020;27(12):38-48 (in Russian)]. DOI:10.18565/pharmateca.2020.12.38-48
46. Шинкин М.В., Звенигородская Л.А., Мкртумян А.М. Использование лазерной допплеровской флоуметрии и флуоресцентной спектроскопии для оценки состояния микроциркуляторного русла и тканевого метаболизма у больных сахарным диабетом 2 типа на фоне терапии препаратом Субетта®. Эффективная фармакотерапия. 2020;16(12):8-14 [Shinkin MV, Zvenigorodskaya LA, Mkrtumyan AM. Laser doppler flowmetry and fluorescence spectroscopy use to assess the condition of the microcirculatory bed and tissue metabolism in patients with type 2 diabetes mellitus on the background of Subetta therapy. Effective Pharmacotherapy. 2020;16(12):8-14 (in Russian)].
DOI:10.33978/2307-3586-2020-16-12-8-14
47. Sheng Z, Cao JY, Pang YC, et al. Effects of Lifestyle Modification and Anti-diabetic Medicine on Prediabetes Progress: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2019;10:455. DOI:10.3389/fendo.2019.00455
48. Madsen KS, Chi Y, Metzendorf MI, et al. Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2019;12(12):CD008558. DOI:10.1002/14651858.CD008558.pub2
49. Bonora E. Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl. 2002;(129):5-11.
50. Ceriello A, Davidson J, Hanefeld M, et al. Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr Metab Cardiovasc Dis. 2006;16(7):453-6. DOI:10.1016/j.numecd.2006.05.006
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1. Dedov II, Shestakova MV, Galstyan GR. The prevalence of type 2 diabetes mellitus in the adult population of Russia (NATION study). Diabetes Mellitus. 2016;19(2):104-12 (in Russian). DOI:10.14341/DM2004116-17
2. Tabák AG, Herder C, Rathmann W, et al. Prediabetes: a high-risk state for diabetes development. Lancet. 2012;379(9833):2279-90. DOI:10.1016/S0140-6736(12)60283-9
3. Souza CF, Gross JL, Gerchman F, Leitão CB. Pré-diabetes: diagnóstico, avaliação de complicações crônicas e tratamento. Arq Bras Endocrinol Metabol. 2012;56(5):275-84. DOI:10.1590/s0004-27302012000500001
4. Heianza Y, Arase Y, Fujihara K, et al. Screening for pre-diabetes to predict future diabetes using various cut-off points for HbA(1c) and impaired fasting glucose: the Toranomon Hospital Health Management Center Study 4 (TOPICS 4). Diabet Med. 2012;29(9):e279-85. DOI:10.1111/j.1464-5491.2012.03686.x
5. Mando R, Waheed M, Michel A, et al. Prediabetes as a risk factor for major adverse cardiovascular events. Ann Med. 2021;53(1):2090-8. DOI:10.1080/07853890.2021.2000633
6. Hostalek U. Global epidemiology of prediabetes – present and future perspectives. Clin Diabetes Endocrinol. 2019;5:5. DOI:10.1186/s40842-019-0080-0
7. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403. DOI:10.1056/NEJMoa012512
8. Lee CC, Perkins BA, Kayaniyil S, et al. Peripheral Neuropathy and Nerve Dysfunction in Individuals at High Risk for Type 2 Diabetes: The PROMISE Cohort. Diabetes Care. 2015;38(5):793-800. DOI:10.2337/dc14-2585
9. Huang Y, Cai X, Mai W, et al. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016;355:i5953. DOI:10.1136/bmj.i5953
10. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE study group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative analysis оf Diagnostic criteria in Europe. Lancet. 1999;354(9179):617-21.
11. Ametov AS. Modern aspects of type 2 diabetes mellitus pathogenesis: β-cell, what's wrong with you? Endocrinology: News, Opinions, Training. 2022;11(4):8-20 (in Russian). DOI:10.33029/2304-9529-2022-11-4-8-20
12. International diabetes federation: IDF diabetes atlas. 10th edition, 2021. Available at: https://diabetesatlas.org/data/en. Accessed: 25.02.2024.
13. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. Pod red. II Dedova, MV Shestakovoi, AIu Maiorova. Vyp. 11. Moscow. 2023 (in Russian). DOI:10.14341/DM13042
14. Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003;26(3):725-31. DOI:10.2337/diacare.26.3.725
15. Misnikova IV, Dreval' AV, Dzebisashvili TG. Identification of risk groups for type 2 diabetes mellitus based on findrisс questionnaire. Almanac of Clinical Medicine. 2015;(1):46-50 (in Russian). DOI:10.18786/2072-0505-2015-1-46-50
16. Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677-86. DOI:10.1016/S0140-6736(09)61457-4
17. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015;3(11):866-75. DOI:10.1016/S2213-8587(15)00291-0
18. Tuomilehto J, Lindström J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(18):1343-50. DOI:10.1056/NEJM200105033441801
19. Lindström J, Ilanne-Parikka P, Peltonen M, et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006;368(9548):1673-9. DOI:10.1016/S0140-6736(06)69701-8
20. Li G, Zhang P, Wang J, et al. Cardiovascular mortality, all-cause mortality, and diabetes incidence after lifestyle intervention for people with impaired glucose tolerance in the Da Qing Diabetes Prevention Study: a 23-year follow-up study. Lancet Diabetes Endocrinol. 2014;2(6):474-80. DOI:10.1016/S2213-8587(14)70057-9
21. Gong Q, Zhang P, Wang J, et al. Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study. Lancet Diabetes Endocrinol. 2019;7(6):452-61. DOI:10.1016/S2213-8587(19)30093-2
22. Mkrtumyan AM, Egshatyan LV. Subetta – a New Activator of the Insulin Receptor. Effective Pharmacotherapy. 2019;15(12):12-7 (in Russian).
DOI:10.33978/2307-3586-2019-15-12-12-17
23. Ametov AS, Demidova TYu, Mkrtumyan AM, et al. Challenge in modern endocrinology: search for combined treatment on the back of insulin resistance (lecture). Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2020;9(1):60-9 (in Russian). DOI:10.33029/2304-9529-2020-9-1-60-69
24. Stumvoll M, Häring HU. Glitazones: clinical effects and molecular mechanisms. Ann Med. 2002;34(3):217-24.
25. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-71. DOI:10.1056/NEJMoa072761
26. WHO Pharmaceuticals Newsletter. Pharmaceutical Journal. 1999;3(4). Available at: https://www.researchgate.net/publication/316554424. Accessed: 25.02.2024.
27. Parke-Davis. Letter to Healthcare Professionals. 1998. 28 July. Available at: https://www.researchgate.net/publication/316554424. Accessed: 25.02.2024.
28. Pereverzev AP, Ostroumova OD, Kochetkov AI. Drug-induced liver damage with cholestasis. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2020;(3):61-74 (in Russian). DOI:10.37489/2588-0519-2020-3-61-74
29. Cañás M. Troglitazona retiro del mercado. 2000. Available at: https://www.researchgate.net/publication/316554424_Troglitazona_retiro_del_mercado. Accessed: 25.02.2024.
30. ElSayed NA, Aleppo G, Aroda VR, et al. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023. Diabetes Care.
2023;46(Suppl. 1):S41-8. DOI:10.2337/dc23-S003
31. Ametov AS, Prudnikova MA. Metformin prolonged release – a new standard for the treatment of type 2 diabetes. Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2015;1:19-26 (in Russian).
32. Ratner RE, Christophi CA, Metzger BE, et al. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008;93(12):4774-9. DOI:10.1210/jc.2008-0772
33. Diabetes Prevention Program Research Group. Long-term Effects of Metformin on Diabetes Prevention: Identification of Subgroups That Benefited Most in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2019;42(4):601-8. DOI:10.2337/dc18-1970
34. Ametov AS, Barykina IN, Bondar IA, et al. Adherence of patients to the metformin therapy with prolonged action (Glucophage® long) in real clinical practice in the Russian Federation. Endokrinologiya: novosti, mneniya, obuchenie = Endocrinology: News, Opinions, Training. 2017;4:52-63 (in Russian). DOI:10.24411/2304-9529-2017-00054
35. Garber AJ, Handelsman Y, Grunberger G, et al. Сonsensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2020 executive summary. Endocr Pract. 2020;26(1):107-39. DOI:10.4158/CS-2019-0472
36. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359(9323):2072-7.
DOI:10.1016/S0140-6736(02)08905-5
37. Biologicheskie lekarstvennye preparaty, poluchennye na osnove gradual'noi tekhnologii. Obshchaia farmakopeinaia stat'ia №OFS.1.7.0001. Data vvedeniia 01.09.2023. Available at: https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-9/biologicheskie-lekarstvennye-preparat.... Accessed: 25.02.2024 (in Russian).
38. Nicoll J, Gorbunov EA, Tarasov SA, Epstein OI. Subetta treatment increases adiponectin secretion by mature human adipocytes in vitro. Int J Endocrinol. 2013;2013:925874. DOI:10.1155/2013/925874
39. Ouedraogo R, Wu X, Xu SQ, et al. Adiponectin suppression of high-glucose-induced reactive oxygen species in vascular endothelial cells: evidence for involvement of a cAMP signaling pathway. Diabetes. 2006;55(6):1840-6. DOI:10.2337/db05-1174
40. Goldstein BJ, Scalia RG, Ma XL. Protective vascular and myocardial effects of adiponectin. Nat Clin Pract Cardiovasc Med. 2009;6(1):27-35. DOI:10.1038/ncpcardio1398
41. Tao L, Gao E, Jiao X, et al. Adiponectin cardioprotection after myocardial ischemia/reperfusion involves the reduction of oxidative/nitrative stress. Circulation. 2007;115(11):1408-16. DOI:10.1161/CIRCULATIONAHA.106.666941
42. Gorbunov EA, Nicoll J, Kachaeva EV, et al. Subetta increases phosphorylation of insulin receptor β-subunit alone and in the presence of insulin. Nutr Diabetes. 2015;5(7):e169. DOI:10.1038/nutd.2015.20
43. Gorbunov EA, Nicoll J, Myslivets AA, et al. Subetta Enhances Sensitivity of Human Muscle Cells to Insulin. Bull Exp Biol Med. 2015;159(4):463-5. DOI:10.1007/s10517-015-2992-8
44. Mkrtumyan A, Ametov A, Demidova T, et al. A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta. J Clin Med. 2022;11(5). DOI:10.3390/jcm11051390
45. Mkrtumyan AM, Vorobyev SV, Volkova AR, Vorokhobina NV. Effects of Subetta® on glycemic control in patients with type 2 diabetes mellitus: results of a multicenter, double-blind, placebo-controlled, randomized clinical study. Farmateka. 2020;27(12):38-48 (in Russian). DOI:10.18565/pharmateca.2020.12.38-48
46. Shinkin MV, Zvenigorodskaya LA, Mkrtumyan AM. Laser doppler flowmetry and fluorescence spectroscopy use to assess the condition of the microcirculatory bed and tissue metabolism in patients with type 2 diabetes mellitus on the background of Subetta therapy. Effective Pharmacotherapy. 2020;16(12):8-14 (in Russian).
DOI:10.33978/2307-3586-2020-16-12-8-14
47. Sheng Z, Cao JY, Pang YC, et al. Effects of Lifestyle Modification and Anti-diabetic Medicine on Prediabetes Progress: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2019;10:455. DOI:10.3389/fendo.2019.00455
48. Madsen KS, Chi Y, Metzendorf MI, et al. Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2019;12(12):CD008558. DOI:10.1002/14651858.CD008558.pub2
49. Bonora E. Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl. 2002;(129):5-11.
50. Ceriello A, Davidson J, Hanefeld M, et al. Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr Metab Cardiovasc Dis. 2006;16(7):453-6. DOI:10.1016/j.numecd.2006.05.006
Авторы
А.М. Мкртумян*
ФГБОУ ВО «Российский университет медицины» Минздрава России, Москва, Россия;
ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия
*vagrashot@mail.ru
________________________________________________
Ashot M. Mkrtumyan*
Russian University of Medicine, Moscow, Russia;
Loginov Moscow Clinical Scientific Center, Moscow, Russia
*vagrashot@mail.ru