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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Pharmateca</journal-id><journal-title-group><journal-title xml:lang="en">Pharmateca</journal-title><trans-title-group xml:lang="ru"><trans-title>Фарматека</trans-title></trans-title-group></journal-title-group><issn publication-format="print">2073-4034</issn><issn publication-format="electronic">2414-9128</issn><publisher><publisher-name xml:lang="en">Bionika Media</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">295714</article-id><article-id pub-id-type="doi">10.18565/pharmateca.2018.11.8-16</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>Articles</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>Статьи</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Potentials for the management of cardiovascular risk in diabetic patients on insulin therapy</article-title><trans-title-group xml:lang="ru"><trans-title>Возможность управления сердечно-сосудистым риском у больных сахарным диабетом, находящихся на инсулинотерапии</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="spin">9815-7509</contrib-id><name-alternatives><name xml:lang="en"><surname>Galstyan</surname><given-names>Gagik R.</given-names></name><name xml:lang="ru"><surname>Галстян</surname><given-names>Г. Р</given-names></name></name-alternatives><bio xml:lang="en"><p>MD, Professor</p></bio><bio xml:lang="ru"><p>д.м.н., проф.</p></bio><email>galstyangagik964@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="spin">1035-4773</contrib-id><name-alternatives><name xml:lang="en"><surname>Antsiferov</surname><given-names>M. B</given-names></name><name xml:lang="ru"><surname>Анциферов</surname><given-names>М. Б</given-names></name></name-alternatives><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="spin">4954-0700</contrib-id><name-alternatives><name xml:lang="en"><surname>Alekseeva</surname><given-names>Ya. G</given-names></name><name xml:lang="ru"><surname>Алексеева</surname><given-names>Я. Г</given-names></name></name-alternatives><xref ref-type="aff" rid="aff3"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">National Medical Research Center for Endocrinology</institution></aff><aff><institution xml:lang="ru">Национальный медицинский исследовательский центр эндокринологии</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">Endocrinological Dispensary of the Moscow Healthcare Department</institution></aff><aff><institution xml:lang="ru">Эндокринологический диспансер Департамента здравоохранения г. Москвы</institution></aff></aff-alternatives><aff id="aff3"><institution></institution></aff><pub-date date-type="pub" iso-8601-date="2018-10-20" publication-format="electronic"><day>20</day><month>10</month><year>2018</year></pub-date><volume>25</volume><issue>11</issue><issue-title xml:lang="en">NO11 (2018)</issue-title><issue-title xml:lang="ru">№11 (2018)</issue-title><fpage>8</fpage><lpage>16</lpage><history><date date-type="received" iso-8601-date="2023-02-27"><day>27</day><month>02</month><year>2023</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2018, Bionika Media</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2018, ООО «Бионика Медиа»</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="en">Bionika Media</copyright-holder><copyright-holder xml:lang="ru">ООО «Бионика Медиа»</copyright-holder></permissions><self-uri xlink:href="https://journals.eco-vector.com/2073-4034/article/view/295714">https://journals.eco-vector.com/2073-4034/article/view/295714</self-uri><abstract xml:lang="en"><p>Diabetes mellitus (DM) contributes to the development of a number of severe vascular complications and a significant increase in cardiovascular risk, which leads to early disability and premature death of patients. The evaluation of cardiovascular safety of both new and traditionally used for many years hypoglycemic drugs and their combinations contributes to the development of more effective therapeutic strategies and recommendations for the prevention of adverse cardiovascular events and improve the prognosis of diabetes. The article presents a comparative analysis of the safety of basal insulin analogues for DM2 patients in relation to the risk of developing severe hypoglycemia and cardiovascular safety. Analysis of data from randomized clinical trials, databases of real-life clinical practice, as well as the largest study of cardiovascular safety of insulin analogues to date, DEVOTE study, makes it clear that insulin degludec, possessing sugar-lowering efficacy and cardiovascular safety comparable to other basal insulin preparations, has several advantages, namely a lower risk of developing severe hypoglycemic episodes, a greater likelihood of achieving target levels of fasting glycemia, as well as the possibility of a more flexible regimen of drug administration.</p></abstract><trans-abstract xml:lang="ru"><p>Сахарный диабет (СД) способствует развитию ряда тяжелых сосудистых осложнений и значительному повышению сердечно-сосудистого риска, что обусловливает раннюю инвалидизацию и преждевременную смерть больных. Изучение сердечно-сосудистой безопасности как новых, так и традиционно используемых на протяжении многих лет сахароснижающих препаратов и их комбинаций способствует разработке более эффективных терапевтических стратегий и рекомендаций для предупреждения неблагоприятных сердечно-сосудистых событий и улучшения прогноза при СД. В статье представлен сравнительный анализ безопасности базальных аналогов инсулина для пациентов СД 2 типа в отношении риска развития тяжелых гипогликемий и сердечно-сосудистой безопасности. Анализ данных рандомизированных клинических исследований, баз данных реальной клинической практики, а также самого крупного на сегодняшний день исследования сердечно-сосудистой безопасности аналогов инсулина DEVOTE не оставляет сомнений в том, что инсулин деглудек, обладая сопоставимой с другими базальными инсулинами сахароснижающей эффективностью и сердечно-сосудистой безопасностью, имеет ряд преимуществ, а именно более низкий риск развития тяжелых гипогликемических эпизодов, большую вероятность достижения целевых уровней показателей гликемии натощак, а также возможность более гибкого режима введения препарата.</p></trans-abstract><kwd-group xml:lang="en"><kwd>diabetes mellitus</kwd><kwd>cardiovascular diseases</kwd><kwd>cardiovascular risk</kwd><kwd>glucose-lowering drugs</kwd><kwd>insulin analogues</kwd><kwd>insulin degludec</kwd><kwd>hypoglycemia</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>сахарный диабет</kwd><kwd>сердечно-сосудистые заболевания</kwd><kwd>сердечно-сосудистый риск</kwd><kwd>сахароснижающие препараты</kwd><kwd>аналоги инсулина</kwd><kwd>инсулин деглудек</kwd><kwd>гипогликемия</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Дедов И.И., Шестакова М.В., Викулова О.К., и др. Сахарный диабет в Российской Федерации: распространенность, заболеваемость, смертность, параметры углеводного обмена и структура сахароснижающей терапии по данным Федерального регистра сахарного диабета, статус 2017 г Сахарный диабет. 2018;21(3):144-59.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Дедов И.И., Шестакова М.В., Викулова О.К. Эпидемиология сахарного диабета в Российской Федерации: клинико-статистический отчет по данным Федерального регистра сахарного диабета. Сахарный диабет 2017;20(1):13-</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>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.</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>Seshasai S.R., Kaptoge S., Thompson A., et al. Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N. Engl J. Med. 2011;364:829-41. Doi: W.W56/NEJMoaW08862.</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>Mazzone T., Chait A., Plutzky J. Cardiovascular disease risk in type 2 diabetes mellitus: insights from mechanistic studies. Lancet. 2008;371 (9626):1800-809. Doi:10.1016/ S0140-6736(08)60768-0.</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>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 (UKPDS33). Lancet. 1998;352:837-53.</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>Stratton I.M., Adler A.I., Neil H.A. et al. Association of glycaemia with macrovascular and microvascular complications of Type 2 diabetes (UKPDS 35): prospective observational study. Br Med J. 2000;321:405-12.</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>Gerstein H.C., Miller M.E., Byington R.P., et al. Effects of intensive glucose lowering in type 2 diabetes. N. Engl J. Med. 2008;358:2545559.</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>Riddle M.C., Ambrosius W.T., Brillon D.J., et al. Epidemiologic relationships between A1C and allcause mortality during a median 3.4-year follow-up of glycemic treatment in the ACCORD trial. Diabetes Care. 2010;33:983-90. Doi: 10.2337/ dc09-1278.</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>Duckworth W., Abraira C., Moritz T., et al. Glucose Controle and Vascular Complications in Veterans with Type 2 Diabetes. N. Engl J. Med. 2009;360:129-39. Doi: 10.1056/ NEJMoa0808431.</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>ADVANCE Collaborative Group, Patel A., MacMahon S. et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N. Engl. J. Med. 2008;358(24):2560-72. Doi: 10.1056/NEJMoa0802987.</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>Ceriello A., Novials A., Ortega E., et al. Evidence that hyperglycemia after recovery from hypoglycemia worsens endothelial function and increases oxidative stress and inflammation in healthy control subjects and subjects with type 1 diabetes. Diabetes. 2012;61:2993-97. Doi: 10.2337/db12-0224.</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>Zinman B., Marso S.P., Poulter N.R., et al. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2018;61:48-57. Doi: 10.1007/ s00125-017-4423-z</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>Laight D.W., Carrier M.J., Ànggârd E.E. Endothelial cell dysfunction and the pathogenesis of diabetic macroangiopathy. Diabetes Metab Res Rev. 1999;15:274-82</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>DeFronzo R.A. Insulin resistance, lipotoxicity, type 2 diabetes and atherosclerosis: the missing links. The Claude Bernard Lecture 2009. Diabetologia. 2010;53:1270-87. Doi: 10.1007/s00125-010-1684-1</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>Laakso M. Cardiovascular disease in type 2 diabetes from population to man to mechanisms. Diabetes Care. 2010;33:442-49. Doi: 10.2337/dc09-0749.</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>Laakso M., Kuusisto J. Insulin resistance and hyperglycaemia in cardiovascular disease development. NatRev Endocrinol. 2014;10(5):293-302. Doi: 10.1038/nrendo.2014.29.</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>Martin-Timon I., Sevillano-Collantes C., Marfn-Penalver J.J., del Canizo-Gomez FJ. Management of cardiovascular risk factors in type 2 diabetes mellitus patients. EMJ. 2016;1(4):89-97.</mixed-citation></ref><ref id="B19"><label>19.</label><mixed-citation>US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes mellitus evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008.</mixed-citation></ref><ref id="B20"><label>20.</label><mixed-citation>European Medicines Agency Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. 2012.</mixed-citation></ref><ref id="B21"><label>21.</label><mixed-citation>Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Алгоритмы специализированной медицинской помощи больным сахарным диабетом / Под ред. И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. 8-й выпуск. Сахарный диабет. 2017;20(1):1-121.</mixed-citation></ref><ref id="B22"><label>22.</label><mixed-citation>Rensinga K.L., von der Thüsenb J.H., Weijers E.M., et al. Endothelial insulin receptor expression in human atherosclerotic plaques: Linking micro- and macrovascular disease in diabetes? Atherosclerosis. 2012;222:208-15. Doi: 10.1016/j. atherosclerosis.2012.01.035.</mixed-citation></ref><ref id="B23"><label>23.</label><mixed-citation>Wang X., Yu C., Zhang B., Wang Y. The injurious effects of hyperinsulinism on blood vessels. Cell Biochem Biophys. 2014;69:213-18. Doi: 10.1007/s12013-013-9810-6.</mixed-citation></ref><ref id="B24"><label>24.</label><mixed-citation>Xun P., Wu Y., He Q., He K. Fasting insulin concentrations and incidence of hypertension, stroke, and coronary heart disease: a metaanalysis of prospective cohort studies. Am J. Clin Nutr. 2013;98(6):1543-54. Doi: 10.3945/ ajcn.113.065565.</mixed-citation></ref><ref id="B25"><label>25.</label><mixed-citation>Engel-Nitz N.M., Martin S., Sun P., et al. Cardiovascular events and insulin therapy: A retrospective cohort analysis. Diabetes Research and Clinical Practice. 2008;81(1):97-104. Doi: 10.1016/j.diabres.2008.02.011.</mixed-citation></ref><ref id="B26"><label>26.</label><mixed-citation>Li J., Tong Yu., Zhang Yu., Tang L., et al. Effects on All-cause Mortality and Cardiovascular Outcomes in Patients With Type 2 Diabetes by Comparing Insulin With Oral Hypoglycemic Agent Therapy: A Meta-analysis of Randomized Controlled Trials. Clinical Therapeutics. 2016;38(2):372-86.e6. Doi: 10.1016/j.clinthera.2015.12.006.</mixed-citation></ref><ref id="B27"><label>27.</label><mixed-citation>Martin-Timon I., Sevillano-Collantes C., Segura-Galindo A., del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J. Diabetes. 2014;5:444-70. Doi: 10.4239/wjd.v5.i4.444.</mixed-citation></ref><ref id="B28"><label>28.</label><mixed-citation>Marso S.P., Daniels G.H., Brown-Frandsen K., et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N. Engl JMed 2016;375: 311-22.</mixed-citation></ref><ref id="B29"><label>29.</label><mixed-citation>Zinman B., Wanner C., Lachin J.M., et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N. Engl J. Med. 2015;373:2117-28.</mixed-citation></ref><ref id="B30"><label>30.</label><mixed-citation>Schwartz T.B., Meinert C.L. The UGDP controversy: thirty-four years of contentious ambiguity laid to rest. Perspect. Biol Med. 2004;47:564-74.</mixed-citation></ref><ref id="B31"><label>31.</label><mixed-citation>Holman R.R., Paul S.K., Bethel M.A., et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N. Engl J. Med. 2008;359:1577-89. Doi: 10.1056/NEJMoa0806470.</mixed-citation></ref><ref id="B32"><label>32.</label><mixed-citation>Malmberg K., Rydén L., Hamsten A., et al. Effects of insulin treatment on cause- specific one-year mortality and morbidity in diabetic patients with acute myocardial infarction. European Heart J. 1996;9:1337-44.</mixed-citation></ref><ref id="B33"><label>33.</label><mixed-citation>Malmberg K. Prospective randomized study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. BMJ. 1997;314:1512-20.</mixed-citation></ref><ref id="B34"><label>34.</label><mixed-citation>Malmberg K., Ryden L., Wedel H., et al. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J. 2005;26:650-61.</mixed-citation></ref><ref id="B35"><label>35.</label><mixed-citation>ORIGIN Trial Investigators. Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE). Diabetes Care. 2016;39:709-16. Doi: 10.2337/ dc15-1676.</mixed-citation></ref><ref id="B36"><label>36.</label><mixed-citation>ORIGIN Trial Investigators. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care. 2016;39(5):709-16. Doi: 10.2337/dc15-1676.</mixed-citation></ref><ref id="B37"><label>37.</label><mixed-citation>Инструкция по медицинскому применению лекарственного препарата Тресиба (URL: http:// grls.rosminzdrav.ru)</mixed-citation></ref><ref id="B38"><label>38.</label><mixed-citation>Heise T., Hermanski L., Nosek L., et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14:859-64. Doi: 10.1111/j.1463-1326.2012.01627.x.</mixed-citation></ref><ref id="B39"><label>39.</label><mixed-citation>Heise T., Norskov M., Nosek L., et al. Insulin degludec: lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017;19:1032-39. Doi: 10.1111/dom.12938.</mixed-citation></ref><ref id="B40"><label>40.</label><mixed-citation>Ratner R.E., Gough S.C., Mathieu C., et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15:175-84. Doi: 10.1111/dom.12032</mixed-citation></ref><ref id="B41"><label>41.</label><mixed-citation>Lane W.S., Bailey T.S., Gerety G., et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017;318:33-44. Doi: 10.1001/ jama.2017.7115</mixed-citation></ref><ref id="B42"><label>42.</label><mixed-citation>Wysham C.H., Bhargava A., Chaykin L.B., et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA. 2017;318:45-56. Doi: 10.1001/ jama.2017.7117</mixed-citation></ref><ref id="B43"><label>43.</label><mixed-citation>Siegmund T., Tentolouris N., Knudsen S.T., et al. A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes Metab. 2018;20:689-697. Doi: 10.1111/dom.13149</mixed-citation></ref><ref id="B44"><label>44.</label><mixed-citation>Marso S.P., McGuire D.K., Zinman B., et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med 2017;377:723-32. Doi: 10.1056/NEJMoa1615692</mixed-citation></ref><ref id="B45"><label>45.</label><mixed-citation>Goto A., Arah O.A., Goto M., et al. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ. 2013;347:4533. Doi: 10.1136/ bmj.f4533.</mixed-citation></ref><ref id="B46"><label>46.</label><mixed-citation>Pieber T.R., Marso S.P., McGuire D.K., et al. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2018;61:58-65. Doi:10.1007/s00125-017-4422-0.</mixed-citation></ref><ref id="B47"><label>47.</label><mixed-citation>Frier B.M., Schernthaner G., Heller S.R. Hypoglycemia and cardiovascular risks. Diabetes Care. 2011;34(2):132-37.</mixed-citation></ref><ref id="B48"><label>48.</label><mixed-citation>Chow E., Bernjak A, Williams S., et al. Risk of cardiac arrhythmias during hypoglycemia in patients with type 2 diabetes and cardiovascular risk. Diabetes. 2014;63:1738-47. Doi: 10.2337/ db13-0468.</mixed-citation></ref><ref id="B49"><label>49.</label><mixed-citation>Chow E., Bernjak A, Walkinshaw E., et al. Cardiac autonomic regulation and repolarization during acute experimental hypoglycemia in type 2 diabetes. Diabetes. 2017;66:1322-33. Doi: 10.2337/db16-1310.</mixed-citation></ref></ref-list></back></article>
