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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">10.30895/2312-7821-2025-13-3-300-312</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-508</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>ГЛАВНАЯ ТЕМА: БЕЗОПАСНОСТЬ ПАЦИЕНТА: КАК ДОКЛИНИЧЕСКИЕ ДАННЫЕ И ПОСТРЕГИСТРАЦИОННЫЙ ФАРМАКОНАДЗОР ФОРМИРУЮТ СОВРЕМЕННЫЙ ЛАНДШАФТ ФАРМАКОТЕРАПИИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>MAIN TOPIC: PATIENT SAFETY: THE WAY PRECLINICAL DATA AND POST-AUTHORISATION PHARMACOVIGILANCE SHAPE MODERN PHARMACOTHERAPEUTIC LANDSCAPE</subject></subj-group></article-categories><title-group><article-title>Безопасность двойной антитромбоцитарной терапии после острого инфаркта миокарда и приверженность пациентов лечению: анализ данных ЕМИАС</article-title><trans-title-group xml:lang="en"><trans-title>Safety of Post-Infarction Dual Antiplatelet Therapy and Patient Adherence: EMIAS Data Analysis</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8395-419X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фитилев</surname><given-names>С. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Fitilev</surname><given-names>S. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Фитилев Сергей Борисович, д-р мед. наук, профессор</p><p>ул. Миклухо-Маклая, д. 6, Москва, 117198</p><p>ул. Фруктовая, д. 12, Москва, 117556</p></bio><bio xml:lang="en"><p>Sergey B. Fitilev, Dr. Sci. (Med.), Professor</p><p>6 Miklukho-Maklay St., Moscow 117198</p><p>12 Fruktovaya St., Moscow 117556</p></bio><email xlink:type="simple">fitilev-sb@rudn.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/0000-0002-0070-3115</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шкребнева</surname><given-names>И. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Shkrebneva</surname><given-names>I. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шкребнева Ирина Ивановна, канд. мед. наук, доцент</p><p>ул. Миклухо-Маклая, д. 6, Москва, 117198</p><p>ул. Фруктовая, д. 12, Москва, 117556</p></bio><bio xml:lang="en"><p>Irina I. Shkrebneva, Cand. Sci. (Med.), Associate Professor</p><p>6 Miklukho-Maklay St., Moscow 117198</p><p>12 Fruktovaya St., Moscow 117556</p></bio><email xlink:type="simple">shkrebneva-ii@rudn.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/0000-0003-2400-3938</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Клюев</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Klyuev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Клюев Дмитрий Алексеевич, канд. фарм. наук</p><p>ул. Миклухо-Маклая, д. 6, Москва, 117198</p></bio><bio xml:lang="en"><p>Dmitry A. Klyuev, Cand. Sci. (Pharm.)</p><p>6 Miklukho-Maklay St., Moscow 117198</p></bio><email xlink:type="simple">dmitrijkluev07@yandex.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/0000-0002-2687-5986</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Возжаев</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Vozzhaev</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Возжаев Александр Владимирович, д-р фарм. наук, доцент</p><p>ул. Миклухо-Маклая, д. 6, Москва, 117198</p></bio><bio xml:lang="en"><p>Alexander V. Vozzhaev, Dr. Sci. (Pharm.), Associate Professor</p><p>6 Miklukho-Maklay St., Moscow 117198</p></bio><email xlink:type="simple">vozzhaev-av@rudn.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/0009-0006-5245-3791</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Оваева</surname><given-names>А. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Ovaeva</surname><given-names>A. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Оваева Анна Олеговна</p><p>ул. Миклухо-Маклая, д. 6, Москва, 117198</p></bio><bio xml:lang="en"><p>Anna O. Ovaeva</p><p>6 Miklukho-Maklay St., Moscow 117198</p></bio><email xlink:type="simple">ovaeva-ao@rudn.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы» ; Государственное бюджетное учреждение здравоохранения города Москвы «Городская поликлиника № 2 Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Patrice Lumumba Peoples’ Friendship University of Russia; City Polyclinic No. 2, Moscow Healthcare Department</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы» ; Государственное бюджетное учреждение здравоохранения города Москвы «Городская поликлиника № 2 Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Patrice Lumumba Peoples’ Friendship University of Russia ;  City Polyclinic No. 2, Moscow Healthcare Department</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Patrice Lumumba Peoples’ Friendship University of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>29</day><month>09</month><year>2025</year></pub-date><volume>13</volume><issue>3</issue><fpage>300</fpage><lpage>312</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Фитилев С.Б., Шкребнева И.И., Клюев Д.А., Возжаев А.В., Оваева А.О., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Фитилев С.Б., Шкребнева И.И., Клюев Д.А., Возжаев А.В., Оваева А.О.</copyright-holder><copyright-holder xml:lang="en">Fitilev S.B., Shkrebneva I.I., Klyuev D.A., Vozzhaev A.V., Ovaeva A.O.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" 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/508">https://www.risksafety.ru/jour/article/view/508</self-uri><abstract><p>ВВЕДЕНИЕ. Реальную эффективность и безопасность двойной антитромбоцитарной терапии (ДАТТ) целесообразно оценивать, если есть уверенность, что пациенты выполняют предписания врачей. Для поиска причин неприверженности ДАТТ необходим совокупный анализ развития нежелательных реакций (НР), их врачебной коррекции и развития клинически значимых ишемических событий у пациентов после острого инфаркта миокарда (ОИМ).ЦЕЛЬ. Провести анализ частоты и тяжести геморрагических реакций в зависимости от приверженности пациентов двойной антитромбоцитарной терапии на основании данных Единой медицинской информационно-аналитической системы (ЕМИАС) за 2021–2023 гг. (г. Москва) для оценки влияния на клинические исходы.МАТЕРИАЛЫ И МЕТОДЫ. Проведен ретроспективный анализ данных ЕМИАС о пациентах, находившихся под диспансерным наблюдением кардиологов московской поликлиники в течение 1 года после ОИМ. Для регистрации НР использовали рекомендованный ВОЗ метод, основанный на учете всех медицинских записей о пациенте. Приверженность ДАТТ оценивали методом учета реализованных электронных рецептов. В анализ включены 168 пациентов, приверженных ДАТТ в первые 6 месяцев терапии.РЕЗУЛЬТАТЫ. При выписке из стационара пациенты получали ацетилсалициловую кислоту в дозе 100 мг (97,6%) в комбинации с ингибитором Р2Y12-рецепторов тромбоцитов, преимущественно тикагрелором (76,2%). Комплексную приверженность ДАТТ во втором полугодии утратили 73 (44,5%) человека (неприверженные). Геморрагии любой степени тяжести в течение года зарегистрированы у 24,4% пациентов (общее число НР — 57); в первом полугодии — у 15,5%. Во втором полугодии степень тяжести кровотечений по шкале BARC была выше среди сохранивших приверженность пациентов по сравнению с неприверженными (p=0,035). Коррекция ДАТТ кардиологами осуществлялась у 29,3% пациентов с кровотечениями, чаще в первом полугодии (22% против 7,3% во втором; р=0,029). Число госпитализаций по кардиальным причинам во втором полугодии было выше у неприверженных пациентов (р=0,047), которые преимущественно отказывались от приема ацетилсалициловой кислоты (доля обеспеченных дней 52,9±26,9%) в среднем на протяжении 111,7±37,7 сут («обрыв» терапии).ВЫВОДЫ. Только 56,5% пациентов после ОИМ сохранили приверженность ДАТТ во втором полугодии. Частота геморрагических НР за год составила 24,4%. Данные НР были тяжелее у приверженных (p=0,035), однако госпитализации по кардиальным причинам преобладали у неприверженных пациентов (p=0,047). Необходим мониторинг баланса риска кровотечений и тромботических событий при длительной ДАТТ; целесообразна персонализация подхода в клинической практике: стратификация риска кровотечений с использованием шкал PRECISE-DAPT/BARC, для пациентов с высоким риском — ранний переход на монотерапию (например, клопидогрел после 3–6 мес.) с акцентом на баланс между антиишемической эффективностью и геморрагическим риском.</p></abstract><trans-abstract xml:lang="en"><p>INTRODUCTION. Actual effectiveness and safety of dual antiplatelet therapy (DAPT) can be evaluated only when patients genuinely adhere to prescribed therapy. Investigating the causes of non-adherence to DAPT inevitably involves a comprehensive analysis of adverse drug reactions (ADR), their clinical management, and the occurrence of clinically significant ischemic events in patients surviving acute myocardial infarction (AMI).AIM. This study aimed to analyse the adherence dynamics to DAPT in the context of haemorrhagic complications, their pharmacological management, and clinically significant cardiac events in patients over the first year following AMI. The data were provided by Unified Medical Information Analysis System (EMIAS), Moscow, for the years 2021-2023. MATERIALS AND METHODS. A retrospective analysis was performed using EMIAS data on patients who were under outpatient follow-up by cardiologists at a Moscow polyclinic for one year following AMI. "Method based on assessment of all medical records" (WHO) was used to register ADRs. Patient medication adherence was evaluated by tracking prescripton claims for individual DAPT components and in total. Only patients who demonstrated adherence to DAPT during the first six months of therapy (n=168) were included in the analysis.RESULTS. Upon hospital discharge, patients received acetylsalicylic acid 100 mg (97.6%) in combination with a P2Y12 platelet inhibitor, predominantly ticagrelor (76.2%). During the second six-month period, 73 (44.5%) patients lost adherence to DAPT (non-adherent). Haemorrhages of any severity were recorded in 24.4% of patients over the year (total ADRs — 57); and in 15.5% in the first six months. Within 6–12 months, compared to non-adherent patients, the severity of bleeding according to the BARC scale was higher among those who maintained adherence (p=0.035), with serious haemorrhagic ADRs observed only in this group. DAPT adjustment by cardiologists was performed in 29.3% of patients with bleeding, more often in the first half of the year than in the second (22% vs 7.3%; p=0.029). The number of hospitalisations for cardiac reasons in 6–12 months was higher in the non-adherent group (p=0.047), who mainly discontinued acetylsalicylic acid (PDC 52.9±26.9%) for an average of 111.7±37.7 days (“therapy interruption”).CONCLUSIONS. Among patients initially adherent to DAPT in the first six months, only 56.5% maintained adherence in the second half of the year following AMI. The annual incidence of haemorrhagic ADRs was 24.4%. These ADRs were more severe among those who maintained adherence (p=0.035), however, more non-adherent patients were hospitalised for cardiac reasons (p=0.047). Benefit-risk balance of haemorrhages and thrombosis should be monitored for long-term DAPT; personalised approach is feasible in clinical practice, including risk stratification of haemorrhages using PRECISE-DAPT/BARC scales; high-risk patients require early switch to monotherapy (such as clopidogrel after 3–6 months) focusing on the balance between anti-ischaemic effectiveness and risk of haemorrhage.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>геморрагические осложнения</kwd><kwd>двойная антитромбоцитарная терапия</kwd><kwd>доля обеспеченных дней</kwd><kwd>ЕМИАС</kwd><kwd>кровотечения</kwd><kwd>нежелательные реакции</kwd><kwd>острый инфаркт миокарда</kwd><kwd>приверженность фармакотерапии</kwd><kwd>учет реализованных электронных рецептов</kwd></kwd-group><kwd-group xml:lang="en"><kwd>haemorrhagic complications</kwd><kwd>dual antiplatelet therapy</kwd><kwd>proportion of days covered</kwd><kwd>EMIAS</kwd><kwd>bleeding</kwd><kwd>haemorrhage</kwd><kwd>adverse reactions</kwd><kwd>acute myocardial infarction</kwd><kwd>medication adherence</kwd><kwd>pharmacy refill records</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Mauri L, Kereiakes DJ, Yeh RW, et al. 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