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Альманах клинической медицины

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ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ПЕРОРАЛЬНЫХ САХАРОСНИЖАЮЩИХ ПРЕПАРАТОВ У БОЛЬНЫХ САХАРНЫМ ДИАБЕТОМ 2-ГО ТИПА И СЕРДЕЧНО-СОСУДИСТЫМИ ЗАБОЛЕВАНИЯМИ

https://doi.org/10.18786/2072-0505-2014-32-80-88

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Аннотация

Сахарный диабет является важной проблемой здравоохранения во всех странах мира. Наличие сахарного диабета 2-го типа (СД2) способствует развитию атеросклероза и повышает риск сердечно-сосудистых осложнений (ССО). Коррекция уровня гликемии служит важнейшим условием профилактики сосудистых осложнений у больных СД2. Возможности снижения риска ССО на фоне терапии пероральными сахароснижающими препаратами продолжают изучаться. В этом отношении перспективны представители инновационных классов пероральных сахароснижающих препаратов, в том числе ингибиторы дипептидилпептидазы-4.

Об авторах

Е. И. Макеева
ФГБУ «Российский кардиологический научно-производственный комплекс» Минздрава России (РКНПК); 121552, г. Москва, ул. 3-я Черепковская, 15а, Российская Федерация
Россия
аспирант отдела ангиологии Института клинической кардиологии, РКНПК


Е. В. Оскола
ФГБУ «Российский кардиологический научно-производственный комплекс» Минздрава России (РКНПК); 121552, г. Москва, ул. 3-я Черепковская, 15а, Российская Федерация
Россия
аспирант отдела ангиологии Института клинической кардиологии, РКНПК


А. Т. Шубина
ФГБУ «Российский кардиологический научно-производственный комплекс» Минздрава России (РКНПК); 121552, г. Москва, ул. 3-я Черепковская, 15а, Российская Федерация
Россия

канд. мед. наук, науч. сотр. отдела ангиологии Института клинической кардиологии, РКНПК.



Ю. А. Карпов
ФГБУ «Российский кардиологический научно-производственный комплекс» Минздрава России (РКНПК); 121552, г. Москва, ул. 3-я Черепковская, 15а, Российская Федерация
Россия

д-р мед. наук, профессор, руководитель отдела ангиологии Института клинической кардиологии, РКНПК; первый зам. ген. директора РКНПК, зам. ген. директора по науке РКНПК



Список литературы

1. IDF Diabetes Atlas. 6th edition. International Diabetes Federation; 2013. Available from: URL: http://www.idf.org/diabetesatlas

2. Дедов ИИ, Шестакова МВ, ред. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 6-й выпуск. М.: Информполиграф; 2013. (Dedov II, Shestakova MV. [Algorithms of the specialized medical aid for diabetes mellitus patients]. 6th edition. Moscow: Inform-poligraf; 2013. Russian).

3. Дедов ИИ, Шестакова МВ, Аметов АС, Анциферов МБ, Галстян ГР, Майоров АЮ, Мкртумян АМ, Петунина НА, Сухарева ОЮ. Консенсус совета экспертов Российской ассоциации эндокринологов (РАЭ) по инициации и интенсификации сахароснижающей терапии сахарного диабета 2 типа. Сахарный диабет. 2011; (4):6-17. (Dedov II, Shestakova MV, Ametov AS, Antsiferov MB, Galstyan GR, Mayorov AYu, Mkrtumyan AM, Petunina NA, Sukhareva OYu. [Russian Association of Endocrinologists expert consensus document on initiation and intensification of antyhyperglycaemic therapy in type 2 diabetes mellitus]. Sakharnyy diabet. 2011; (4): 6-17. Russian).

4. Tuomilehto J, Rastenyte D, Qiao Q, Jakovljevic D. Epidemiology of macrovascular disease and hypertension in diabetes mellitus. In: De Fronso RA, Ferranini E, Keen H, Zimmet P, editors. International Texbook of Diabetes Mellitus, 3rd edition. Milan: John and Wiley Sons; 2004.

5. Stokes J 3rd, Kannel WB, Wolf PA, Cupples LA, D’Agostino RB. The relative importance of selected risk factors for various manifestations of cardiovascular disease among men and 87 women from 35 to 64 years old: 30 years of follow-up in the Framingham Study. Circulation.1987;75(6 Pt 2):65-73.

6. Wolf PA, D’Agostino RB, Belanger AJ, Kannel WB. Probability of stroke: a risk profile from the Framingham Study. Stroke. 1991;22(3):312-8.

7. Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Predictors of stroke in middle-aged patients with non-insulin-dependent diabetes. Stroke. 1996;27(1):63-8.

8. American Diabetes Association. Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care. 2000;23 Suppl 1:S27-31.

9. Davis TME, Coleman RL, Holman RR; UKPDS Group. Prognostic significance of silent myocardial infarction in newly diagnosed type 2 diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS). Circulation. 2013;127(9):980-7.

10. Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr., Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545-59.

11. ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560-72.

12. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364-79.

13. Ismail-Beigi F, Moghissi E, Tiktin M, Hirsch IB, Inzucchi SE, Genuth S. Individualizing glycemic targets in type 2 diabetes mellitus: implications of recent clinical trials. Ann Intern Med. 2011;154(8):554-9.

14. Akalin S, Berntorp K, Ceriello A, Das AK, Kilpatrick ES, Koblik T, Munichoodappa CS, Pan CY, Rosenthall W, Shestakova M, Wolnik B, Woo V, Yang WY, Yilmaz MT; Global Task Force on Glycaemic Control. Intensive glucose therapy and clinical implications of recent data: a consensus statement from the Global Task Force on Glycaemic Control. Int J Clin Pract. 2009;63(10):1421-5.

15. Lee SJ, Eng C. Goals of glycemic control in frail older patients with diabetes. JAMA. 2011;305(13):1350-1.

16. Patrono C, Seferovic P, Uva MS, Taskinen MR, Tendera M, Tuomilehto J, Valensi P, Zamorano JL. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2014;35(27):1824.

17. Meinert CL, Knatterud GL, Prout TE, Klimt CR. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes. 1970;19 Suppl:789-830.

18. Groop LC. Sulfonylureas in NIDDM. Diabetes Care. 1992; 15(6):737-54.

19. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-89.

20. Shaw JS, Wilmot RL, Kilpatrick ES. Establishing pragmatic estimated GFR thresholds to guide metformin prescribing. Diabet Med. 2007;24(10):1160-3.

21. Yki-Järvinen H. Thiazolidinediones. N Engl J Med. 2004; 351(11):1106-18.

22. Nissen SE, Nicholls SJ, Wolski K, Nesto R, Kupfer S, Perez A, Jure H, De Larochellière R, Staniloae CS, Mavromatis K, Saw J, Hu B, Lincoff AM, Tuzcu EM; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008; 299(13):1561-73.

23. Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D’Agostino RB Sr., Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006;296(21):2572-81.

24. 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.

25. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP); 2010 Sep 24 [Internet]. Press release EMA/CHMP/394406/ 2010. Available from: www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500097046.pdf.

26. U.S. Food and Drug Administration. FDA requires removal of certain restrictions on the diabetes drug Avandia [Internet]. [cited 2013 Nov 25]. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm376365

27. Spengler M, Schmitz H, Landen H. Evaluation of the efficacy and tolerability of acarbose in patients with diabetes mellitus: a postmarketing surveillance study. Clin Drug Investig. 2005;25(10):651-9.

28. Sun YN, Zhou Y, Chen X, Che WS, Leung SW. The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials. BMJ Open. 2014;4(4):e004619.

29. Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58). Available from: http://www.clinicaltrials.gov/show/NCT01730534

30. Аметов АС. Современные методы терапии сахарного диабета 2 типа. Русский медицинский журнал. 2008;(4):170-177. (Ametov AS. [Contemporary methods to treat type 2 diabetes mellitus]. Russkiy meditsinskiy zhurnal. 2008;(4): 170-7. Russian).

31. Мкртумян АМ. Патофизиологический подход в лечении сахарного диабета 2 типа. Лечащий врач. 2008;(3):92-5. (Mkrtumyan AM. [Pathophysiologic approach to treatment of type 2 diabetes mellitus]. Lechashchiy vrach 2008;(3):92-5. Russian).

32. Kjems LL, Holst JJ, Vølund A, Madsbad S. The influence of GLP-1 on glucose-stimulated insulin secretion: effects on beta-cell sensitivity in type 2 and nondiabetic subjects. Diabetes. 2003;52(2):380-6.

33. Fehmann HC, Habener JF. Insulinotropic hormone glucagon-like peptide-I(7-37) stimulation of proinsulin gene expression and proinsulin biosynthesis in insulinoma beta TC-1 cells. Endocrinology. 1992;130(1):159-66.

34. Аметов АС, Карпова ЕВ. Инкретиномиметики – новый этап в лечении сахарного диабета 2-го типа. Русский медицинский журнал. 2010;18(23):1410-15. (Ametov AS, Karpova EV. [Incretomimetics – a new stage in treatment of type 2 diabetes mellitus]. Russkiy meditsinskiy zhurnal. 2010;18(23):1410-15. Russian).

35. Аметов АС, Карпова ЕВ. Новая возможность достижения цели лечения пациентов с сахарным диабетом 2 типа. Русский медицинский журнал. 2008;(28):1854-7. (Ametov AS, Karpova EV. [A new opportunity to achieve positive outcome in treatment of type 2 diabetes mellitus]. Russkiy meditsinskiy zhurnal. 2008;(28):1854-7. Russian).

36. Perfetti R. The role of GLP-1 in the regulation of the islet cell mass. Medscape Diabet Endocrinol. 2004;6(2):134-8.

37. Meier JJ, Gallwitz B, Siepmann N, Holst JJ, Deacon CF, Schmidt WE, Nauck MA. Gastric inhibitory polypeptide (GIP) dosedependently stimulates glucagon secretion in healthy human subjects at euglycaemia. Diabetologia. 2003;46(6):798-801.

38. Yip RG, Boylan MO, Kieffer TJ, Wolfe MM. Functional GIP receptors are present on adipocytes. Endocrinology. 1998;139(9):4004-7.

39. Eckel RH, Fujimoto WY, Brunzell JD. Gastric inhibitory polypeptide enhanced lipoprotein lipase activity in cultured preadipocytes. Diabetes. 1979;28(12):1141-2.

40. Oben J, Morgan L, Fletcher J, Marks V. Effect of the enteropancreatic hormones, gastric inhibitory polypeptide and glucagon-like polypeptide-1(7-36) amide, on fatty acid synthesis in explants of rat adipose tissue. J Endocrinol. 1991;130(2): 267-72.

41. Knapper JM, Puddicombe SM, Morgan LM, Fletcher JM. Investigations into the actions of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1(7-36) amide on lipoprotein lipase activity in explants of rat adipose tissue. J Nutr. 1995;125(2):183-8.

42. Beck B, Max JP. Gastric inhibitory polypeptide enhancement of the insulin effect on fatty acid incorporation into adipose tissue in the rat. Regul Pept. 1983;7(1):3-8.

43. Mentlein R. Dipeptidyl-peptidase IV (CD26)-role in the inactivation of regulatory peptides. Regul Pept. 1999;85(1): 9-24.

44. Deacon CF, Nauck MA, Toft-Nielsen M, Pridal L, Willms B, Holst JJ. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes. 1995;44(9):1126-31.

45. Deacon CF, Nauck MA, Meier J, Hücking K, Holst JJ. Degradation of endogenous and exogenous gastric inhibitory polypeptide in healthy and in type 2 diabetic subjects as revealed using a new assay for the intact peptide. J Clin Endocrinol Metab. 2000;85(10):3575-81.

46. Pederson RA, Kieffer TJ, Pauly R, Kofod H, Kwong J, McIntosh CH. The enteroinsular axis in dipeptidyl peptidase IV-negative rats. Metabolism. 1996;45(11):1335-41.

47. Kieffer TJ, McIntosh CH, Pederson RA. Degradation of glucose-dependent insulinotropic polypeptide and truncated glucagon-like peptide 1 in vitro and in vivo by dipeptidyl peptidase IV. Endocrinology. 1995;136(8):3585-96.

48. Аметов АС, Карпова ЕВ. Клиническое использование ингибитора ДПП-4 – вилдаглиптина при сахарном диабете 2 типа. Русский медицинский журнал. 2010;18(14):887-91. (Ametov AS, Karpova EV. [Clinical application of DPP-4-vildagliptin-inhibitor in type 2 diabetes mellitus]. Russkiy meditsinskiy zhurnal. 2010;18(14):887-91. Russian).

49. Cobble ME, Frederich R. Saxagliptin for the treatment of type 2 diabetes mellitus: assessing cardiovascular data. Cardiovasc Diabetol. 2012;11:6.

50. White J. Efficacy and safety of incretin based therapies: clinical trial data. J Am Pharm Assoc (2003). 2009;49 Suppl 1:S30-40.

51. Chrysant SG, Chrysant GS. Clinical implications of cardiovascular preventing pleiotropic effects of dipeptidyl peptidase-4 inhibitors. Am J Cardiol. 2012;109(11):1681-5.

52. Matsubara J, Sugiyama S, Sugamura K, Nakamura T, Fujiwara Y, Akiyama E, Kurokawa H, Nozaki T, Ohba K, Konishi M, Maeda H, Izumiya Y, Kaikita K, Sumida H, Jinnouchi H, Matsui K, Kim-Mitsuyama S, Takeya M, Ogawa H. A dipeptidyl peptidase-4 inhibitor, des-fluoro-sitagliptin, improves endothelial function and reduces atherosclerotic lesion formation in apolipoprotein E-deficient mice. J Am Coll Cardiol. 2012;59(3):265-76.

53. Vittone F, Liberman A, Vasic D, Ostertag R, Esser M, Walcher D, Ludwig A, Marx N, Burgmaier M. Sitagliptin reduces plaque macrophage content and stabilises arteriosclerotic lesions in Apoe (-/-) mice. Diabetologia. 2012;55(8):2267-75.

54. Lim S, Choi SH, Shin H, Cho BJ, Park HS, Ahn BY, Kang SM, Yoon JW, Jang HC, Kim YB, Park KS. Effect of a dipeptidyl peptidase-IV inhibitor, des-fluoro-sitagliptin, on neointimal formation after balloon injury in rats. PLoS One. 2012;7(4):e35007.

55. Liu L, Liu J, Wong WT, Tian XY, Lau CW, Wang YX, Xu G, Pu Y, Zhu Z, Xu A, Lam KS, Chen ZY, Ng CF, Yao X, Huang Y. Dipeptidyl peptidase 4 inhibitor sitagliptin protects endothelial function in hypertension through a glucagon-like peptide 1-dependent mechanism. Hypertension. 2012;60(3):833-41.

56. Mason RP, Jacob RF, Kubant R, Walter MF, Bellamine A, Jacoby A, Mizuno Y, Malinski T. Effect of enhanced glycemic control with saxagliptin on endothelial nitric oxide release and CD40 levels in obese rats. J Atheroscler Thromb. 2011;18(9): 774-83.

57. Kubota Y, Miyamoto M, Takagi G, Ikeda T, Kirinoki-Ichikawa S, Tanaka K, Mizuno K. The dipeptidyl peptidase-4 inhibitor sitagliptin improves vascular endothelial function in type 2 diabetes. J Korean Med Sci. 2012;27(11):1364-70.

58. van Poppel PC, Netea MG, Smits P, Tack CJ. Vildagliptin improves endothelium-dependent vasodilatation in type 2 diabetes. Diabetes Care. 2011;34(9):2072-7.

59. Matsui T, Nishino Y, Takeuchi M, Yamagishi S. Vildagliptin blocks vascular injury in thoracic aorta of diabetic rats by suppressing advanced glycation end product-receptor axis. Pharmacol Res. 2011;63(5):383-8.

60. Lenski M, Kazakov A, Marx N, Böhm M, Laufs U. Effects of DPP-4 inhibition on cardiac metabolism and function in mice. J Mol Cell Cardiol. 2011;51(6):906-18.

61. Ye Y, Perez-Polo JR, Aguilar D, Birnbaum Y. The potential effects of anti-diabetic medications on myocardial ischemia-reperfusion injury. Basic Res Cardiol. 2011;106(6):925-52.

62. Ye Y, Keyes KT, Zhang C, Perez-Polo JR, Lin Y, Birnbaum Y. The myocardial infarct size-limiting effect of sitagliptin is PKA-dependent, whereas the protective effect of pioglitazone is partially dependent on PKA. Am J Physiol Heart Circ Physiol. 2010;298(5):H1454-65.

63. Hocher B, Sharkovska Y, Mark M, Klein T, Pfab T. The novel DPP-4 inhibitors linagliptin and BI 14361 reduce infarct size after myocardial ischemia/reperfusion in rats. Int J Cardiol. 2013;167(1):87-93.

64. Liu WJ, Xie SH, Liu YN, Kim W, Jin HY, Park SK, Shao YM, Park TS. Dipeptidyl peptidase IV inhibitor attenuates kidney injury in streptozotocin-induced diabetic rats. J Pharmacol Exp Ther. 2012;340(2):248-55.

65. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz Itamar, for the SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-26.

66. Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J. 2013;166(6):983-9.e7.

67. White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327-35.

68. Gallwitz B, Uhlig-Laske B, Bhattacharaya S, Patel S, Woerle H-J. Linagliptin has similar efficacy to glimepiride but improved cardiovascular safety over 2 years in patients with type 2 diabetes inadequately controlled on metformin. Diabetes. 71th Scientific Sessions 2011;LB11.

69. Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012;380(9840): 475-83.

70. Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012;11:3.


Для цитирования:


Макеева Е.И., Оскола Е.В., Шубина А.Т., Карпов Ю.А. ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ПЕРОРАЛЬНЫХ САХАРОСНИЖАЮЩИХ ПРЕПАРАТОВ У БОЛЬНЫХ САХАРНЫМ ДИАБЕТОМ 2-ГО ТИПА И СЕРДЕЧНО-СОСУДИСТЫМИ ЗАБОЛЕВАНИЯМИ. Альманах клинической медицины. 2014;(32):80-88. https://doi.org/10.18786/2072-0505-2014-32-80-88

For citation:


Makeeva E.I., Oskolа E.V., Shubinа A.T., Karpov Y.A. EFFICIENCY AND SAFETY OF THE ORAL HYPOGLYCAEMIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASES. Almanac of Clinical Medicine. 2014;(32):80-88. (In Russ.) https://doi.org/10.18786/2072-0505-2014-32-80-88

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