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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">sibmed</journal-id><journal-title-group><journal-title xml:lang="ru">Сибирский научный медицинский журнал</journal-title><trans-title-group xml:lang="en"><trans-title>Сибирский научный медицинский журнал</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2410-2512</issn><issn pub-type="epub">2410-2520</issn><publisher><publisher-name>ИЦиГ СО РАН</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18699/SSMJ20230403</article-id><article-id custom-type="elpub" pub-id-type="custom">sibmed-1154</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>Оценка мирового и национального рынка гиполипидемических средств: ретроспектива и инновации</article-title><trans-title-group xml:lang="en"><trans-title>Assessment of the global and national market for lipid modifying agents: retrospective and innovation</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1102-9680</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лохмачева</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Lokhmacheva</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Лохмачева Алена Валерьевна, к.фарм.н.</p><p>644099, г. Омск, ул. Ленина, 12</p></bio><bio xml:lang="en"><p>Alena V. Lokhmacheva, candidate of pharmaceutical sciences</p><p>644099, Omsk, Lenina st., 12</p></bio><email xlink:type="simple">asaltuk@mail.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/0000-0002-5575-4083</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фоминых</surname><given-names>С. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Fominykh</surname><given-names>S. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Фоминых Стелла Геннадьевна, д.м.н.</p><p>644099, г. Омск, ул. Ленина, 12</p></bio><bio xml:lang="en"><p>Stella G. Fominykh, doctor of medical sciences</p><p>644099, Omsk, Lenina st., 12</p></bio><email xlink:type="simple">stella_fominyh@mail.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/0000-0002-2292-6520</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Трубина</surname><given-names>Л. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Trubina</surname><given-names>L. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Трубина Лариса Владимировна, к.фарм.н.</p><p>644099, г. Омск, ул. Ленина, 12</p></bio><bio xml:lang="en"><p>Larisa V. Trubina, candidate of pharmaceutical sciences</p><p>644099, Omsk, Lenina st., 12</p></bio><email xlink:type="simple">larisa_trubina@mail.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/0000-0002-8561-1411</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сихвардт</surname><given-names>И. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Sikhvardt</surname><given-names>I. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сихвардт Ирина Эдуардовна</p><p>644099, г. Омск, ул. Ленина, 12</p></bio><bio xml:lang="en"><p>Irina E. Sikhvardt</p><p>644099, Omsk, Lenina st., 12</p></bio><email xlink:type="simple">sihvardtiren@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Омский государственный медицинский университет Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Omsk State Medical University of Minzdrav of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>29</day><month>08</month><year>2023</year></pub-date><volume>43</volume><issue>4</issue><fpage>23</fpage><lpage>43</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Лохмачева А.В., Фоминых С.Г., Трубина Л.В., Сихвардт И.Э., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Лохмачева А.В., Фоминых С.Г., Трубина Л.В., Сихвардт И.Э.</copyright-holder><copyright-holder xml:lang="en">Lokhmacheva A.V., Fominykh S.G., Trubina L.V., Sikhvardt I.E.</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://sibmed.elpub.ru/jour/article/view/1154">https://sibmed.elpub.ru/jour/article/view/1154</self-uri><abstract><p>Гиполипидемическая терапия является одним из важнейших аспектов в лечении пациентов с сердечно-сосудистыми заболеваниями, которые по-прежнему лидируют среди причин смертности взрослого населения. За последние 10 лет в обращении появились принципиально новые гиполипидемические средства, такие как алипогена типарвовек, мипомерсен, ломитапид, эволокумаб, алирокумаб, бемпедоевая кислота, инклисиран, эвинакумаб, воланесорсен. С целью актуализации информации по эффективности и безопасности применения гиполипидемических препаратов, их потребления на фармацевтическом рынке в ретроспективе и в настоящее время нами проведен систематический поиск в научных базах данных eLIBRARY.RU, PubMed, Embase, ClinicalTrials. gov, Кокрейновской библиотеки, Государственного реестра лекарственных средств за период с 1980 по 2023 г. Статины остаются главными препаратами выбора для регулярного применения при нарушении липидного обмена. Фибраты являются препаратами выбора у больных с редко встречающимися формами гиперлипидемии в сочетании с высоким уровнем триглицеридов. Охарактеризована группа других гиполипидемических средств с позиции механизмов действия, показаний к применению, наличия регистрационных удостоверений в РФ и мире. Возрастающий интерес к эзетимибу на российском фармацевтическом рынке подтверждается высоким ростом доли локальных компаний в его производстве в рамках стратегии импортозамещения. Установлено, что в составе комбинированной терапии препарат вызывает нежелательные эффекты с малой долей вероятности. Ингибиторы пропротеиновой конвертазы субтилизин-кексинового типа 9 (PCSK9) открывают новые возможности для лечения пациентов с очень высоким риском сердечно-сосудистых заболеваний. Ломитапид не зарегистрирован в РФ, однако с декабря 2021 г. внесен в перечень лекарственных препаратов, закупаемых фондом «Круг добра» для оказания помощи детям с гомозиготной семейной гиперхолестеринемией. В России с 2022 г. разрешен к применению инклисиран – препарат, ингибирующий синтез PCSK9 с помощью РНК-интерференции, безопасный у пациентов с гиперлипидемией и с непереносимостью статинов. Таким образом, в XXI в. в группе гиполипидемических средств появились принципиально новые позиции, являющиеся примерами биотехнологических и генотерапевтических лекарственных препаратов.</p></abstract><trans-abstract xml:lang="en"><p>Lipid-lowering therapy is one of the most important aspects in the treatment of patients with cardiovascular disease, which is still the leading cause of death in the adult population. Over the past 10 years, fundamentally new lipid-lowering drugs have appeared such as alipogene tiparvovec, mipomersen, lomitapide, evolocumab, alirocumab, bempedoic acid, inclisiran, evinacumab, volanesorsen. In order to update information on the effectiveness and safety of the use of lipidlowering drugs, their consumption in the pharmaceutical market in retrospect and at the present time, a systematic search was carried out in the scientific databases eLIBRARY.RU, PubMed, Embase, ClinicalTrials.gov, the Cochrane Library, Russian State Register of Medicines from 1980 to 2023. Statins remain the main drugs of choice for regular use in violation of lipid metabolism. Fibrates are the drugs of choice in patients with rare forms of hyperlipidemia associated with high triglyceride level. A group of other lipid-lowering drugs has been characterized from the point of view of the mechanisms of action, indications for use, and the availability of registration certificates in the Russian Federation and in the world. The growing interest in ezetimibe in the Russian pharmaceutical market is confirmed by the high growth in the share of local companies in its production as part of the import substitution strategy. It has been established that the drug causes undesirable effects with a small degree of probability as part of combination therapy. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) open up new possibilities for the treatment of patients at very high risk of cardiovascular disease. Lomitapide is not registered in the Russian Federation, but since December 2021 it has been included in the list of medicines purchased by the Krug Dobra Foundation to help children with homozygous familial hypercholesterolemia. Since 2022, inclisiran, a drug inhibiting synthesis of PCSK9 with RNA interference, has been approved for use in Russia and is safe in patients with hyperlipidemia and statin intolerance. Thus, in the 21st century, fundamentally new positions have appeared in the group of lipid-lowering drugs, which are examples of biotechnological and gene therapy drugs.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>гиполипидемические средства</kwd><kwd>гиперхолестеринемия</kwd><kwd>статины</kwd><kwd>фибраты</kwd><kwd>эзетимиб</kwd><kwd>ломитапид</kwd><kwd>эволокумаб</kwd><kwd>алирокумаб</kwd><kwd>инклисиран</kwd></kwd-group><kwd-group xml:lang="en"><kwd>lipid-lowering agents</kwd><kwd>hypercholesterolemia</kwd><kwd>statins</kwd><kwd>fibrates</kwd><kwd>ezetimibe</kwd><kwd>lomitapide</kwd><kwd>evolocumab</kwd><kwd>alirocumab</kwd><kwd>inclisiran</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">World Health Organization. The top 10 causes of death. 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