diaendoСахарный диабетDiabetes mellitus2072-03512072-0378Endocrinology research centre10.14341/2072-0351-5548diaendo-5548Research ArticleСтатьиArticlesЭффективность и безопасность терапии аналогами инсулина у ранее не получавших инсулин пациентов с сахарным диабетом 2 типа в повседневной клинической практике: результаты многоцентрового наблюдательного 52-недельного исследования A1chieveEfficacy and safety of treatment with human insulin analogues in daily management of insulin naive patients with type 2 diabetes mellitus: results of multicenter 52-week observational study A1chiveШестаковаМарина ВладимировнаShestakovaMarina Vladimirovnanephro@endocrincentr.ruФГБУ "Эндокринологический научный центр" Минздрава РоссииРоссияEndocrinology Research CentreRussian Federation201215122012154№4 (2012)115121Copyright © Шестакова М.В., 20122012Шестакова М.В.Shestakova M.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/5548

Современные аналоги инсулина позволяют безопасно (без повышения риска развития тяжелых гипогликемических состояний и увеличения массы тела) улучшить гликемический контроль и эффективно поддерживать его в течение длительного времени. В статье представлены результаты многоцентрового проспективного 52-недельного наблюдательного исследования A1chieve (Российская когорта, n=9342), целью которого была оценка безопасности и эффективности терапии сахарного диабета 2 типа аналогами инсулина Левемир?, НовоМикс? 30 и НовоРапид? (Ново Нордиск) у ранее не получавших инсулинотерапию пациентов в условиях повседневной клинической практики. Назначение аналогов инсулина привело к клинически и статистически значимому улучшению гликемического контроля, независимо от стартового режима инсулинотерапии. Начало инсулинотерапии при различных стартовых режимах (Левемир?, НовоМикс? 30 или Левемир? + НовоРапид?) в условиях повседневной клинической практики приводит к выраженному улучшению гликемического контроля по динамике HbA1c (-2,9% через 12 месяцев) при отсутствии свидетельств негативного влияния на переносимость и краткосрочную безопасность терапии. При этом снижение уровня HbA1c ассоциировалось с выраженным и стабильным снижением уровня глюкозы плазмы натощак и постпрандиальной гликемии (-5,0 ммоль/л и -5,7 ммоль/л соответственно). На всех режимах терапии к концу исследования отмечалось значимое улучшение оценки качества жизни по критерию ?оценка удовлетворенности проводимым лечением?.

Modern insulin analogues allow safe improvement of glycemic control (not accompanied with increase in body mass or rate of severe hypoglycemic events) and its efficient maintenance during long period of time. In this paper we present results of multicenter 52-week prospective observational study A1chive (Russian cohort, n=9342), designed to assess safety and efficacy of treatment with human insulin analogues (Levemir?, NovoMix? 30 and NovoRapid? (Novo Nordisk) in daily management of insulin naive patients with type 2 diabetes mellitus. Prescription of human insulin analogues resulted in clinically and statistically significant improvement of glycemic control irrespective of initial insulin regimen. Therapy by various regimens (Levemir?, NovoMix? 30 or Levemir? + NovoRapid?) under conditions of daily clinical practice leads to marked improvement in glycemic control as measured by HbA1c (-2.9% in 12 month) with no evidence for negative influence on tolerability and short-term safety of the treatment. Furthermore, decrease in HbA1c levels was associated with pronounced and stable decrease in fasting and postprandial glucose levels (-5.0 mmol/L and -5.7 mmol/L, respectively). By the end of the follow-up all regimen groups reported improvement of QoL by treatment satisfaction criterion.

сахарный диабет 2 типанаблюдательное исследованиеаналоги инсулинаA1chievediabetes mellitus type 2observational studyA1chieveinsulin analoguesReferencesKhaw KT, Wareham N, Bingham S, Luben R, Welch A, Day N. Association of hemoglobin a1c with cardiovascular disease and mortality in adults: the European prospective investigation into cancer in Norfolk. Ann Intern Med. 2004 Sep 21;141(6):413-420.Khaw KT, Wareham N, Bingham S, Luben R, Welch A, Day N. Association of hemoglobin a1c with cardiovascular disease and mortality in adults: the European prospective investigation into cancer in Norfolk. Ann Intern Med. 2004 Sep 21;141(6):413-420.WHO 2011. Global Atlas on CVD prevention and control. p. 1-164.WHO 2011. Global Atlas on CVD prevention and control. p. 1-164.UK Prospective Diabetes Study (UKPDS) Group. UKPDS 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 Sep 12;352(9131):837-853.UK Prospective Diabetes Study (UKPDS) Group. UKPDS 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 Sep 12;352(9131):837-853.Pharmacotherapy. 2007 Riedel AA, Heien H, Wogen J, Plauschinat CA. Loss of glycemic control in patients with type 2 diabetes mellitus who were receiving initial metformin, sulfonylurea, or thiazolidinedione monotherapy. Pharmacotherapy. 2007 Aug; 27(8): 1102-1110.Pharmacotherapy. 2007 Riedel AA, Heien H, Wogen J, Plauschinat CA. Loss of glycemic control in patients with type 2 diabetes mellitus who were receiving initial metformin, sulfonylurea, or thiazolidinedione monotherapy. Pharmacotherapy. 2007 Aug; 27(8): 1102-1110.Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care. 2005 Mar;28(3):600-606.Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care. 2005 Mar;28(3):600-606.Guyatt GH, Bombardier C, Tugwell PX. Measuring diseasespecific quality of life in clinical trials. Canadian CMAJ. 1986 Apr 15;134(8):889-895.Guyatt GH, Bombardier C, Tugwell PX. Measuring diseasespecific quality of life in clinical trials. Canadian CMAJ. 1986 Apr 15;134(8):889-895.Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of Insulin Injection Omission. Diabetes Care. 2010 Feb;33(2):240- 245.Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of Insulin Injection Omission. Diabetes Care. 2010 Feb;33(2):240- 245.Shestakova M.V. A1chieve Program in Russian Federation: a multicenter prospective observational study of insulin analogue treatment efficiency and safety in daily management of patients with type 2 diabetes mellitus, who start and intensify insulin treatment having never received it before. Diabetes mellitus. 2012;(1):63-70.Shestakova M.V. A1chieve Program in Russian Federation: a multicenter prospective observational study of insulin analogue treatment efficiency and safety in daily management of patients with type 2 diabetes mellitus, who start and intensify insulin treatment having never received it before. Diabetes mellitus. 2012;(1):63-70.Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; PREFER Study Group. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab. 2009 Jan;11(1):45-52. Epub 2008 Jul 17.Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; PREFER Study Group. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab. 2009 Jan;11(1):45-52. Epub 2008 Jul 17.Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in Type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-1747. Epub 2009 Oct 22.Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in Type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-1747. Epub 2009 Oct 22.Rosenthal MJ, Fajardo M, Gilmore S, Morley JE, Naliboff BD. Hospitalization and mortality of diabetes in older adults: a three-year prospective study. Diabetes Care. 1998 Feb;21(2):231-235.Rosenthal MJ, Fajardo M, Gilmore S, Morley JE, Naliboff BD. Hospitalization and mortality of diabetes in older adults: a three-year prospective study. Diabetes Care. 1998 Feb;21(2):231-235.

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