cardiovascularКардиоваскулярная терапия и профилактикаCardiovascular Therapy and Prevention1728-88002619-0125«SILICEA-POLIGRAF» LLC10.15829/1728-8800-2022-3243cardiovascular-3243Research ArticleОБЗОРЫ ЛИТЕРАТУРЫREVIEW ARTICLESКонечные точки: виды, особенности выбора, интерпретация полученных результатов на примере кардиологических исследованийEndpoints: types, selection, interpretation of the results obtained on the example of cardiology studieshttps://orcid.org/0000-0002-4022-2981НавасардянА. Р.NavasardyanA. R.

Артур Рубенович Навасардян — кандидат медицинских наук, руководитель группы региональных медицинских советников компании.

Москва, Тел.: +7 (926) 558-38-81

Moscow

bk_nar@mail.ruhttps://orcid.org/0000-0002-7717-4362МарцевичС. Ю.MartsevichS. Yu.

Сергей Юрьевич Марцевич — доктор медицинских наук, профессор, руководитель отдела профилактической фармакотерапии.

Москва

Moscow

smartsevich@gnicpm.ruАртур Рубенович Навасардян — кандидат медицинских наук, руководитель группы региональных медицинских советников компании. Москва, Тел.: +7 (926) 558-38-81Bayer, AOНациональный медицинский исследовательский центр терапии и профилактической медицины. Россия, 101990, Москва, Петроверигский пер., 10National Medical Research Center for Therapy and Preventive Medicine20220406202221532433243Copyright © Навасардян А.Р., Марцевич С.Ю., 20222022Навасардян А.Р., Марцевич С.Ю.Navasardyan A.R., Martsevich S.Y.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://cardiovascular.elpub.ru/jour/article/view/3243

Важность проведения качественных рандомизированных контролируемых исследований на современном этапе развития медицины сложно переоценить. Каждое такое исследование пытается дать ответ на конкретный клинический вопрос. Для этого необходимо заранее задать показатель достижения конкретного результата за определенный период времени. Этим показателем является конечная точка (КТ) исследования, т.е. тот или иной исход заболевания или изменение лабораторных и функциональных показателей организма. Ее выбор напрямую влияет на предполагаемый дизайн и на объем выборки исследования. В статье приведена классификация и иерархия КТ (в зависимости от цели), описаны особенности и ограничения применения важных клинических исходов и суррогатных показателей. Описаны причины, почему широкое распространение в кардиологических исследованиях получили именно комбинированные КТ. Отдельного внимания заслуживает интерпретация КТ в рамках вторичного анализа, положительный результат которых можно оценить только в том случае, если будет продемонстрирован эффект лечения по первичному показателю эффективности или безопасности. Текущий обзор дополнен клиническими примерами исследований, выполненных в кардиологии.

The importance of high-quality randomized controlled trials cannot be overemphasized. Each such study attempts to answer a specific clinical question. To do this, it is necessary to determine in advance the indicator of achievement of a specific result for a certain period of time. This indicator is the endpoint (EP) of the study, i.e. one or another outcome of the disease or a change in the laboratory and functional characteristics. Its choice directly affects the intended design and sample size of the study. The article provides a classification and hierarchy of EPs (depending on the purpose), describes the features and limitations of the use of important clinical outcomes and surrogate indicators. The reasons why composite EPs are widely used in cardiology studies are described. Special attention should be paid to EP interpretation within secondary analysis, a positive result of which can only be assessed if a treatment effect is demonstrated in terms of the primary indicator of efficacy or safety. The current review is supplemented by clinical examples of cardiology studies.

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