diaendoСахарный диабетDiabetes mellitus2072-03512072-0378Endocrinology research centre10.14341/DM12799diaendo-12799Research ArticleОригинальные исследованияOriginal StudiesМесто гликлазида МВ в структуре сахароснижающей терапии на примере регистра сахарного диабета Московской областиGliclazide MR in the structure of antihyperglycemic therapy according to the data of Moscow region diabetes registerhttps://orcid.org/0000-0003-1668-8711МисниковаИ. В.MisnikovaI. V.

Мисникова Инна Владимировна, доктор медицинских наук, профессор

129110, Москва, ул. Щепкина, д. 61/2

eLibrary SPIN: 3614-3011

Inna V. Misnikova, MD, PhD, Professor

61/2, Schepkina str, 129110, Moscow

eLibrary SPIN: 3614-3011

inna-misnikova@mail.ruhttps://orcid.org/0000-0001-7327-2486КовалеваЮ. А.KovalevaYu. A.

Ковалева Юлия Александровна, кандидат медицинских наук, старший научный сотрудник

Москва

eLibrary SPIN: 2645-1293

Yulia A. Kovaleva, MD, PhD, senior research associate

Moscow

eLibrary SPIN: 2645-1293

yulia.kovaleva@mail.ruhttps://orcid.org/0000-0002-7813-8013ГубкинаВ. А.GubkinaV. A.

Губкина Валерия Алексеевна, кандидат медицинских наук

Москва

eLibrary SPIN: 6032-6269

Valeriya A. Gubkina, MD, PhD

Moscow

eLibrary SPIN: 6032-6269

gubkinava@mail.ruhttps://orcid.org/0000-0002-3135-9003ДревальА. В.DrevalA. V.

Древаль Александр Васильевич, доктор медицинских наук, профессор

Москва

eLibrary SPIN: 5853-3989

Alexander V. Dreval, MD, PhD, Professor

Moscow

eLibrary SPIN: 5853-3989

dreval@diabet.ruМосковский областной научно-исследовательский клинический интитут им. М.Ф.ВладимирскогоРоссияMoscow Regional Research and Clinical InstituteRussian FederationМосковский областной научно-исследовательский клинический институт им. М.Ф. ВладимирскогоРоссияMoscow Regional Research and Clinical InstituteRussian Federation202211052022252166173Copyright © Мисникова И.В., Ковалева Ю.А., Губкина В.А., Древаль А.В., 20222022Мисникова И.В., Ковалева Ю.А., Губкина В.А., Древаль А.В.Misnikova I.V., Kovaleva Y.A., Gubkina V.A., Dreval A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.dia-endojournals.ru/jour/article/view/12799Актуальность

Актуальность. Препараты сульфонилмочевины (ПСМ) часто используются для 2 и 3-й линий терапии сахарного диабета 2 типа (СД2). В настоящее время нет единых рекомендаций, регламентирующих выбор препаратов для 2-й линии терапии при отсутствии сердечно-сосудистой и почечной патологии, что требует изучения.

Цель

Цель. Изучить данные регистра сахарного диабета (СД) Московской области (МО) для оценки соответствия проводимой сахароснижающей терапии актуальным отечественным и международным рекомендациям по лечению СД2.

МатериалЫ и методы

МатериалЫ и методы. Структура сахароснижающей терапии препаратами неинсулинового ряда (ПНИР) изучалась у пациентов с СД2 по данным регистра СД МО. Анализ проведен по состоянию на 02.06.2021. Анализировались общая группа пациентов с СД2 (237 479 человек), группа пациентов 60 лет и более (188 644 больных). Лица с впервые установленным диагнозом СД2 проанализированы за 2020 г. (5088 человек).

Результаты

Результаты. Медикаментозную сахароснижающую терапию получают 97,6% пациентов с СД2. Из них ПНИР принимают 79,07%, инсулин+ПНИР — 11,37%. На монотерапии находятся 44,4%, на комбинации из 2 препаратов — 29,3%, из 3 — 5,3% пациентов. В назначениях ПНИР лидирует метформин (69,4% всех пациентов и 81,3% при впервые выявленном СД2). ПСМ находятся на 2-м месте при лечении СД2 (50% всех пациентов, 24,1% у впервые выявленных), ингибиторы дипептидилпептидазы 4 — на 3-м месте (12,1 и 12,6% соответственно). Среди лиц 60 лет и более гликлазид МВ принимают 25,99% пациентов, глибенкламид — 14,3%, глимепирид — 7,7%.

Выводы

Выводы. По данным регистра СД МО, терапию ПСМ принимают половина пациентов с СД2 и четверть — с впервые выявленным СД2. В качестве препарата 1-й линии ПСМ занимают 2-е место после метформина и наиболее часто используются в двойной и тройной комбинациях терапии СД2. В старшей возрастной группе из ПСМ отдается предпочтение гликлазиду МВ.

Background

Background: Sulfonylureas (SU) are often used for second and third line type 2 diabetes mellitus (T2DM) therapy. Currently, there are no unified recommendations governing the choice of drugs for the second line therapy. This requires clarification.

Aim

Aim: To examine Moscow Region DM register data for assessing ongoing antihyperglycemic therapy and its correspondence to current local and international T2DM treatment recommendations, as well as actual clinical recommendations for the treatment of T2DM patients and COVID-19.

Materials and methods

Materials and methods: The structure of glucose-lowering therapy with non-insulin drugs (NID) was studied in T2DM patients according to the data T2DM register of Moscow region. The analysis was carried out on 06.02.2021. We analyzed the general group of T2DM patients (237479 people), group 60 years and older (188644 patients), T2DM patients who have had COVID-19. Newly diagnosed T2DM individuals were analyzed for 2020 (5088 people).

Results

Results: Glucose-lowering therapy is received by 97.6% of T2DM patients. Of these, 79.07% take NID, insulin + NID - 11.37%. Monotherapy is received by 44.4% of patients, a combination of two drugs - 29.3%, out of three - 5.3% of patients. Metformin is the leader in prescribing NID (69.4% of all T2DM patients and 81.3% in newly diagnosed patients). SU are in second place in T2DM treatment (50% of all patients, 24.1% in newly diagnosed patients), iIDPP-4 is in third place (12.1% and 12.6%, respectively). Among patients of 60 and more years old, 25.99% of patients take gliclazide MR, 14.3% glibenclamide, 7.7% glimepiride. Mortality from COVID-19 depends on the diabetes duration.

Conclusion

Conclusion: According to the DM register, half of the T2DM patients and a quarter of T2DM newly diagnosed patients get SU. As a first-line drug, SU is on the second place after metformin and are most often used in double and triple combinations of T2DM therapy. In the older age group on SU, preference is given to gliclazide MR.

сахарный диабет 2 типаструктура сахароснижающей терапиипрепараты неинсулинового рядапрепараты сульфонилмочевиныгликлазид МВtype 2 diabetes mellitusthe structure of glucose-lowering therapynon-insulin drugssulfonylureasgliclazide MRReferencesMontvida O, Shaw J, Atherton JJ, et al. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes Care. 2018;41(1):69-78. doi: https://doi.org/10.2337/dc17-1414Montvida O, Shaw J, Atherton JJ, et al. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes Care. 2018;41(1):69-78. doi: https://doi.org/10.2337/dc17-1414Buse JB, Wexler DJ, Tsapas A, et al. 2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2020;63(2):221-228. doi: https://doi.org/10.1007/s00125-019-05039-wBuse JB, Wexler DJ, Tsapas A, et al. 2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2020;63(2):221-228. doi: https://doi.org/10.1007/s00125-019-05039-wInternational Diabetes Federation (IDF) (2020). IDF Clinical practice recommendations for managing type 2 diabetes in primary care. 2017. Available from: https://www.idf.org/our-activities/care-prevention/type-2-diabetes.html. Accessed 21 Jan 2020.International Diabetes Federation (IDF) (2020). IDF Clinical practice recommendations for managing type 2 diabetes in primary care. 2017. Available from: https://www.idf.org/our-activities/care-prevention/type-2-diabetes.html. Accessed 21 Jan 2020.National Institute for Health and Care Excellence. Type 2 diabetes in adults: management. 2015. Available from: https://www.nice.org.uk/guidance/ng28/resources/type-2-diabetes-in-adults-management-pdf-1837338615493. Accessed 21 Jan 2020.National Institute for Health and Care Excellence. Type 2 diabetes in adults: management. 2015. Available from: https://www.nice.org.uk/guidance/ng28/resources/type-2-diabetes-in-adults-management-pdf-1837338615493. Accessed 21 Jan 2020.World Health Organization. Guidelines on second- and third-line medicines and type of insulin for the control of blood glucose in non-pregnant adults with diabetes mellitus. Geneva: World Health Organization; 2018.World Health Organization. Guidelines on second- and third-line medicines and type of insulin for the control of blood glucose in non-pregnant adults with diabetes mellitus. Geneva: World Health Organization; 2018.Кононенко И.В., Смирнова О.М. Должны ли препараты сульфонилмочевины остаться? Возможности гликлазида МВ // Эффективная фармакотерапия. Эндокринология. Спецвыпуск. Сахарный диабет. — 2018. — Т. 12. — С. 6-12.Kononenko IV, Smirnova OM. Dolzhny li preparaty sul’fonilmocheviny ostat’sya? Vozmozhnosti gliklazida MV. Effektivnaya farmakoterapiya. Endokrinologiya. Spetsvypusk. Sakharnyi diabet. 2018;12:6-12. (In Russ.).Алгоритмы специализированной медицинской помощи больным сахарным диабетом / Под редакцией И.И. Дедова, М.В. Шестаковой, Ю.А. Майорова. 10-й выпуск. — М.; 2021. doi: https://doi.org/10.14341/DM12802Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol’nym sakharnym diabetom / Ed. by II Dedov, MV Shestakova, YuA Maiorov. 10 vypusk. Moscow; 2021. (In Russian). doi: https://doi.org/10.14341/DM12802Wilding J, Godec T, Khunti K, et al. Changes in HbA1c and weight, and treatment persistence, over the 18 months following initiation of second-line therapy in patients with type 2 diabetes: results from the United Kingdom Clinical Practice Research Datalink. BMC Med. 2018;16(1):116. doi: https://doi.org/10.1186/s12916-018-1085-8Wilding J, Godec T, Khunti K, et al. Changes in HbA1c and weight, and treatment persistence, over the 18 months following initiation of second-line therapy in patients with type 2 diabetes: results from the United Kingdom Clinical Practice Research Datalink. BMC Med. 2018;16(1):116. doi: https://doi.org/10.1186/s12916-018-1085-8Singla R, Bindra J, Singla A, et al. Drug prescription patterns and cost analysis of diabetes therapy in India: audit of an endocrine practice. Indian J Endocrinol Metab. 2019;23(1):40-45. doi: https://doi.org/10.4103/ijem.IJEM_646_18.Singla R, Bindra J, Singla A, et al. Drug prescription patterns and cost analysis of diabetes therapy in India: audit of an endocrine practice. Indian J Endocrinol Metab. 2019;23(1):40-45. doi: https://doi.org/10.4103/ijem.IJEM_646_18.Khunti K, Godec TR, Medina J, et al. Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany. Diabetes Obes Metab. 2018;20(2):389-399. doi: https://doi.org/10.1111/dom.13083.Khunti K, Godec TR, Medina J, et al. Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany. Diabetes Obes Metab. 2018;20(2):389-399. doi: https://doi.org/10.1111/dom.13083.Matthews DR, Paldanius PM, Proot P, et al. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomized, double-blind trial. Lancet. 2019;394:1519-1529. doi: https://doi.org/10.1016/S0140-6736(19)32131-2.Matthews DR, Paldanius PM, Proot P, et al. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomized, double-blind trial. Lancet. 2019;394:1519-1529. doi: https://doi.org/10.1016/S0140-6736(19)32131-2.Deacon CF, Lebovitz HE. Comparative review of dipeptidyl peptidase-4 inhibitors and sulphonylureas. Diabetes, Obesity and Metabolism, 2016;18(4):333-347. doi: https://doi.org/10.1111/dom.12610Deacon CF, Lebovitz HE. Comparative review of dipeptidyl peptidase-4 inhibitors and sulphonylureas. Diabetes, Obesity and Metabolism, 2016;18(4):333-347. doi: https://doi.org/10.1111/dom.12610Clemens KK, McArthur E, Dixon SN, et al. The Hypoglycemic Risk of Glyburide (Glibenclamide) Compared with Modified-Release Gliclazide. Can J Diabetes. 2015;39(4):308-316. doi: https://doi.org/10.1016/j.jcjd.2015.01.001.Clemens KK, McArthur E, Dixon SN, et al. The Hypoglycemic Risk of Glyburide (Glibenclamide) Compared with Modified-Release Gliclazide. Can J Diabetes. 2015;39(4):308-316. doi: https://doi.org/10.1016/j.jcjd.2015.01.001.WHO package of essential noncommunicable (PEN) disease interventions for primary health care. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGOWHO package of essential noncommunicable (PEN) disease interventions for primary health care. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGODiabetes Canada Clinical Practice Guidelines Expert Committee. Diabetes Canada 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2018;42(Suppl 1):1-325.Diabetes Canada Clinical Practice Guidelines Expert Committee. Diabetes Canada 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2018;42(Suppl 1):1-325.Zaccardi F, Jacquot E, Cortese V, et al. Comparative effectiveness of gliclazide modified release versus sitagliptin as second-line treatment after metformin monotherapy in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2020;22(12):2417-2426. doi: https://doi.org/10.1111/dom.14169.Zaccardi F, Jacquot E, Cortese V, et al. Comparative effectiveness of gliclazide modified release versus sitagliptin as second-line treatment after metformin monotherapy in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2020;22(12):2417-2426. doi: https://doi.org/10.1111/dom.14169.UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352: 837-853.UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352: 837-853.Patel A, MacMahon S, Chalmers J, et al.; Advance Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-2572. doi: https://doi.org/10.1056/NEJMoa0802987.Patel A, MacMahon S, Chalmers J, et al.; Advance Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-2572. doi: https://doi.org/10.1056/NEJMoa0802987.Simpson SH, Majumdar SR, Tsuyuki RT, et al. Dose-response relation between sulfonylurea drugs and mortality in type 2 diabetes mellitus: a population-based cohort study. CMAJ. 2006;174:169-174. doi: https://doi.org/10.1503/cmaj.050748.Simpson SH, Majumdar SR, Tsuyuki RT, et al. Dose-response relation between sulfonylurea drugs and mortality in type 2 diabetes mellitus: a population-based cohort study. CMAJ. 2006;174:169-174. doi: https://doi.org/10.1503/cmaj.050748.Мисникова И.В., Древаль А.В., Ковалева Ю.А. Риски общей и сердечно-сосудистой смертности, а также инфаркта миокарда и острого нарушения мозгового кровообращения у больных сахарным диабетом 2 типа в зависимости от вида стартовой сахароснижающей терапии // Сахарный диабет. — 2009. — Т. 12. — №4. — С. 72-79.. doi: https://doi.org/10.14341/2072-0351-5709doi:Misnikova IV, Dreval’ AV, Kovaleva YA. Initial glucose-lowering therapy and risks of overall and cardiovascular mortality, myocardial infarction and stroke in patients with type2 diabetes. Diabetes Mellit. 2009;12(4):72-79. (In Russ.). doi: https://doi.org/10.14341/2072-0351-5709doi:Simpson SH, Lee J, Choi S, et al. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. Lancet Diabetes Endocrinol. 2015;3(1):43-51. doi: https://doi.org/10.1016/S2213-8587(14)70213-X.Simpson SH, Lee J, Choi S, et al. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. Lancet Diabetes Endocrinol. 2015;3(1):43-51. doi: https://doi.org/10.1016/S2213-8587(14)70213-X.Qian D, Zhang T, Tan X, et al. Comparison of antidiabetic drugs added to sulfonylurea monotherapy in patients with type 2 diabetes mellitus: A network meta-analysis. PLoS ONE. 2018;13(8):e0202563. doi: https://doi.org/10.1371/journal.pone.0202563Qian D, Zhang T, Tan X, et al. Comparison of antidiabetic drugs added to sulfonylurea monotherapy in patients with type 2 diabetes mellitus: A network meta-analysis. PLoS ONE. 2018;13(8):e0202563. doi: https://doi.org/10.1371/journal.pone.0202563Barron E, Bakhai C, Kar P. Associations of type 1 and type 2 diabetes with COVID-19-related mortality in England: a whole-population study. Lancet Diabetes Endocrinol. 2020;8:813-822. doi: https://doi.org/10.1016/S2213-8587(20)30272-2.Barron E, Bakhai C, Kar P. Associations of type 1 and type 2 diabetes with COVID-19-related mortality in England: a whole-population study. Lancet Diabetes Endocrinol. 2020;8:813-822. doi: https://doi.org/10.1016/S2213-8587(20)30272-2.McFadyen JD, Stevens H, Peter K. The emerging threat of (micro)thrombosis in COVID-19 and its therapeutic implications. Circ Res. 2020;127:571-587. doi: https://doi.org/10.1161/CIRCRESAHA.120.317447.McFadyen JD, Stevens H, Peter K. The emerging threat of (micro)thrombosis in COVID-19 and its therapeutic implications. Circ Res. 2020;127:571-587. doi: https://doi.org/10.1161/CIRCRESAHA.120.317447.Khunti K, Knighton P, Zaccardi F. Prescription of glucose-lowering therapies and risk of COVID-19 mortality in people with type 2 diabetes: a nationwide observational study in England. Lancet Diabetes Endocrinol. 2021. doi: https://doi.org/10.1016/S2213-8587(21)00050-4. Published online March 30.Khunti K, Knighton P, Zaccardi F. Prescription of glucose-lowering therapies and risk of COVID-19 mortality in people with type 2 diabetes: a nationwide observational study in England. Lancet Diabetes Endocrinol. 2021. doi: https://doi.org/10.1016/S2213-8587(21)00050-4. Published online March 30.

The authors declare that there are no conflicts of interest present.