vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2023-452vedomostiregmed-452Research ArticleПРОГРАММЫ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙCLINICAL TRIAL PROGRAMMESПланирование программы клинических исследований препаратов для лечения ожиренияPlanning of clinical trial programmes for medicines for the treatment of obesityhttps://orcid.org/0000-0003-0934-5067ПроскуринаИ. А.ProskurinaI. A.

Проскурина Ирина Анатольевна, канд. мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация

Irina A. Proskurina, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Proskurina@expmed.ruhttps://orcid.org/0000-0002-5430-6975ГорскаяТ. Е.GorskayaT. E.

Горская Татьяна Евгеньевна

Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация

Tatiana E. Gorskaya

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

gorskayate@expmed.ruhttps://orcid.org/0000-0001-8583-2372ГорячевД. В.GoryachevD. V.

Горячев Дмитрий Владимирович, д-р мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация

Dmitry V. Goryachev, Dr. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Gorachev@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202303072023134503518Copyright © Проскурина И.А., Горская Т.Е., Горячев Д.В., 20232023Проскурина И.А., Горская Т.Е., Горячев Д.В.Proskurina I.A., Gorskaya T.E., Goryachev D.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/452Актуальность

Актуальность. Нормативные документы и рекомендации по планированию клинических исследований (КИ) новых препаратов для лечения ожирения в Российской Федерации и в других государствах — членах Евразийского экономического союза в настоящее время отсутствуют.

Цель

Цель. Представить рекомендации по основным принципам планирования и проведения КИ препаратов для лечения ожирения.

Обсуждение

Обсуждение. Проведен анализ требований к проведению КИ препаратов для лечения ожирения Европейского агентства по лекарственным средствам, Управления по контролю за качеством продуктов питания и лекарственных средств. Рассмотрены подходы, позволяющие достоверно оценить эффективность и безопасность препаратов для лечения ожирения при проведении КИ. Показано, что первичной конечной точкой является демонстрация статистически значимого снижения массы тела по крайней мере на 5% от исходной массы тела после 12 мес. терапии. Вторичные конечные точки: уменьшение степени выраженности абдоминального ожирения; оценка количества подкожного и висцерального жира; оценка влияния препарата на поддержание сниженной массы тела.

Выводы

Выводы. Должно быть оценено влияние препарата на сердечно-сосудистые факторы риска и сердечно-сосудистую заболеваемость/смертность. В протоколе КИ необходимо представить определение интеркуррентных событий, влияние которых также нужно учитывать при анализе полученных результатов. В отношении безопасности препаратов для лечения ожирения следует сделать акцент на нейропсихической безопасности, потенциале злоупотреблений/зависимости и реакциях отмены, развитии вальвулопатии и легочной гипертензии. Настоящие рекомендации могут использоваться экспертами, осуществляющими оценку программы клинической разработки препаратов для лечения ожирения и экспертизу с целью регистрации.

Scientific relevance

Scientific relevance. Obesity is a significant public health problem. Currently, the Russian Federation and the other Member States of the Eurasian Economic Union (EAEU) do not have regulatory documents and recommendations for planning clinical trials (CTs) of new (original) medicines for the treatment of obesity.

Aim

Aim. The study aimed to provide recommendations on the basic principles of planning and conducting CTs of medicines for the treatment of obesity.

Discussion

Discussion. The authors reviewed the requirements for conducting CTs of medicines for the treatment of obesity set forth by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). In addition, the authors analysed approaches to CTs providing for a reliable evaluation of the efficacy and safety of medicines for the treatment of obesity. The primary endpoint of such CTs is a statistically significant loss of at least 5% of the baseline weight after 12 months of treatment. Secondary endpoints include assessments of abdominal obesity reduction, subcutaneous and visceral fat reduction, and the medicinal product’s effect on maintaining a reduced body weight.

Conclusions

Conclusions. In addition, CTs should investigate the effects of treatment on cardiovascular risk factors and cardiovascular morbidity/mortality. A CT protocol should define the intercurrent events that should be considered in the analysis of trial results. When investigating the safety of medicines for the treatment of obesity, studies should focus on neuropsychiatric safety, the potential for abuse/addiction and withdrawal reactions, and the development of valvulopathy and pulmonary hypertension. These recommendations may be of use to experts evaluating clinical development programmes or marketing authorisation submissions for medicines for the treatment of obesity.

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The authors declare that there are no conflicts of interest present.