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<article article-type="research-article" dtd-version="1.3" 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" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">safetyrisk</journal-id><journal-title-group><journal-title xml:lang="ru">Безопасность и риск фармакотерапии</journal-title><trans-title-group xml:lang="en"><trans-title>Safety and Risk of Pharmacotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2312-7821</issn><issn pub-type="epub">2619-1164</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/2312-7821-2019-7-4-163-175</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-152</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Анализ проблем безопасности применения статинов у пациентов с сахарным диабетом и гипотиреозом</article-title><trans-title-group xml:lang="en"><trans-title>Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1441-3418</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Архипов</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Arkhipov</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Архипов Владимир Владимирович, доктор медицинских наук, доцент, член-корреспондент РАЕ</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Vladimir V. Arkhipov, Dr. Sci. (Med.), Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">arkhipov2005@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7322-3323</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Городецкая</surname><given-names>Г. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Gorodetskaya</surname><given-names>G. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Городецкая Галина Ивановна</p><p>Петровский бульвар, д. 8, стр. 2, Москва, 127051; Трубецкая ул., д. 8, стр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Galina I. Gorodetskaya</p><p>8/2 Petrovsky Blvd, Moscow 127051; 8/2 Trubetskaya St., Moscow 119991</p></bio><email xlink:type="simple">gorodetskaya@expmed.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0123-3044</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Демидова</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Demidova</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Демидова Ольга Александровна, кандидат фармацевтических наук</p><p>Петровский бульвар, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Olga A. Demidova, Cand. Sci. (Pharm.)</p><p>8/2 Petrovsky Blvd, Moscow 127051</p><p> </p></bio><email xlink:type="simple">demidova@expmed.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3855-5899</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александрова</surname><given-names>Т. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Alexandrova</surname><given-names>T. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Александрова Татьяна Владимировна, кандидат медицинских наук</p><p>Петровский бульвар, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Tatiana V. Alexandrova, Cand. Sci. (Med.)</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">aleksandrova@expmed.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6077-4273</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александров</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Alexandrov</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Александров Алексей Александрович</p><p>Петровский бульвар, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Alexey A. Alexandrov</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">alexandrov@expmed.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Scientific Centre for Expert Evaluation of Medicinal Products,<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Scientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical University,<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru">Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Scientific Centre for Expert Evaluation of Medicinal Products<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>13</day><month>11</month><year>2019</year></pub-date><volume>7</volume><issue>4</issue><fpage>163</fpage><lpage>175</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Архипов В.В., Городецкая Г.И., Демидова О.А., Александрова Т.В., Александров А.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Архипов В.В., Городецкая Г.И., Демидова О.А., Александрова Т.В., Александров А.А.</copyright-holder><copyright-holder xml:lang="en">Arkhipov V.V., Gorodetskaya G.I., Demidova O.A., Alexandrova T.V., Alexandrov A.A.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.risksafety.ru/jour/article/view/152">https://www.risksafety.ru/jour/article/view/152</self-uri><abstract><p>Широкое использование статинов в клинической практике предполагает необходимость системного подхода к оценке риска и безопасности их применения. Цель работы: анализ информации о нежелательных реакциях и особенностях их возникновения при применении статинов у пациентов с гиперхолестеринемией в сочетании с сахарным диабетом и гипотиреозом. Проведено сравнение препаратов из группы статинов (симвастатин, аторвастатин, правастатин, розувастатин, флувастатин) по частоте возникновения наиболее значимых нежелательных реакций — статин-индуцированной миопатии, поражения печени, вторичной гипергликемии. Рассмотрены особенности возникновения нежелательных реакций при применении статинов у пациентов с гипотиреозом и сахарным диабетом. Показано, что у пациентов с компенсированным гипотиреозом при наличии аллельных вариантов СС и ТС гена SLCO1B1*5 (c.521T&gt;C) применение статинов сопровождается повышением риска развития статин-индуцированных миопатий. Подбор доз статинов, особенно у пациентов с гипотиреозом и сахарным диабетом, целесообразно проводить по результатам фармакогенетического тестирования по аллельному варианту гена SLCO1B1*5 (c.521T&gt;C). Для коррекции лечения у данной категории пациентов необходимо учитывать в первую очередь результаты динамического клинико-лабораторного контроля уровня печеночных трансаминаз, а также уровней глюкозы, гликированного гемоглобина, тиреотропного гормона. Рассмотрены полиморфизмы генов, носительство которых связано с резистентностью к терапии статинами у пациентов с сахарным диабетом. Таким образом, применение статинов для первичной профилактики и лечения сердечно-сосудистых заболеваний у пациентов с гиперхолестеринемией в сочетании с сахарным диабетом и/или гипотиреозом требует комплексной оценки отношения риск/польза.</p></abstract><trans-abstract xml:lang="en"/><kwd-group xml:lang="ru"><kwd>статины</kwd><kwd>нежелательные реакции</kwd><kwd>безопасность применения</kwd><kwd>статин-индуцированная миопатия</kwd><kwd>гипергликемия</kwd><kwd>сахарный диабет</kwd><kwd>гипотиреоз</kwd></kwd-group><kwd-group xml:lang="en"><kwd>statins</kwd><kwd>adverse reactions</kwd><kwd>security applications</kwd><kwd>statin-induced myopathy</kwd><kwd>hyperglycemia</kwd><kwd>diabetes mellitus</kwd><kwd>hypothyroidism</kwd></kwd-group><funding-group xml:lang="ru"><funding-statement>Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00154-19-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590049-0)</funding-statement></funding-group><funding-group xml:lang="en"><funding-statement>The study reported in this publication was carried out as part of a publicly funded research project № 056- 00154-19-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&amp;D public accounting No. AAAA-A18-118021590049-0)</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Гайсенюк ОВ, Рожков АН, Лишута АС. 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