medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2022-16-4-128-137medsovet-6777Research ArticleРациональная фармакотерапияRational pharmacotherapyЭра двойной бронходилатации: новые возможности в новом средстве доставкиThe double bronchodilation era: new capabilities in a new drug delivery devicehttps://orcid.org/0000-0001-7169-3586ОрловаЕ. А.OrlovaE. A.

Орлова Екатерина Алексеевна, к.м.н., доцент, заведующая кафедрой фармакологии

414000, Астрахань, ул. Бакинская, д. 121

Ekaterina A. Orlova, Cand. Sci. (Med.), Associate Professor, Head of  Pharmacology Department

121, Bakinskaya St., Astrakhan, 414000

eorlova56@mail.ruhttps://orcid.org/0000-0003-1561-0592ДорфманИ. П.DorfmanI. P.

Дорфман Инна Петровна, к.м.н., доцент кафедры клинической фармакологии

414000, Астрахань, ул. Бакинская, д. 121

Inna P. Dorfman, Cand. Sci. (Med.), Associate Professor of Clinical Pharmacology Department

121, Bakinskaya St., Astrakhan, 414000

inna1977@mail.ruhttps://orcid.org/0000-0002-8995-6572ОрловМ. А.OrlovM. A.

Орлов Михаил Александрович, д.м.н., профессор, заведующий кафедрой медицинской реабилитации

414000, Астрахань, ул. Бакинская, д. 121

Mikhail A. Orlov, Dr. Sci. (Med.), Professor, Head of Medical Rehabilitation Department

121, Bakinskaya St., Astrakhan, 414000

orlovdoc56@gmail.comhttps://orcid.org/0000-0001-7374-2660АбдуллаевМ. А.AbdullaevM. A.

Абдуллаев Мусалитдин Абсаламович, аспирант кафедры фармакологии

414000, Астрахань, ул. Бакинская, д. 121

Musalitdin A. Abdullaev, Postgraduate Student of Pharmacology Department

121, Bakinskaya St., Astrakhan, 414000

abdullaev-musalitdin@mail.ruАстраханский государственный медицинский университетРоссияAstrakhan State Medical UniversityRussian Federation20220604202204128137Copyright © Орлова Е.А., Дорфман И.П., Орлов М.А., Абдуллаев М.А., 20222022Орлова Е.А., Дорфман И.П., Орлов М.А., Абдуллаев М.А.Orlova E.A., Dorfman I.P., Orlov M.A., Abdullaev M.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/6777

В обзоре источников литературы показаны эффективность и безопасность применения инновационной комбинации гликопиррония бромида и формотерола фумарата (ГП/ФФ) в лечении пациентов с хронической обструктивной болезнью легких (ХОБЛ) по данным исследований PINNACLE 1, 2, 3, 4. В мировой практике и в России используются 4 фиксированные комбинации длительно действующих β2 -агонистов (ДДБА) и  длительно действующих антихолинергических препаратов (ДДАХ): вилантерол + умеклидиния бромид, гликопиррония бромид + индакатерол, олодатерол + тиотропия бромид и аклидиния бромид + формотерола фумарат. В настоящее время в Global Initiative for Chronic Obstructive Lung Disease (GOLD) присутствует комбинация ГП/ФФ, получившая одобрение в России. Для данной комбинации разработано новое средство доставки косуспензии через ингалятор Аэросфера. Эффективность и  безопасность дозированного аэрозольного ингалятора (ДАИ) ГП/ФФ по сравнению с его монокомпонентами, плацебо и тиотропия бромидом (ТБ) установлены в клинических исследованиях III фазы PINNACLE 1, 2, 3, 4. Также комбинация ГП/ФФ привела к улучшению утренних и последующих через 2 ч показателей объема форсированного выдоха за 1 сек (ОФВ1 ) по сравнению с монокомпонентами и плацебо. Данные исследований PINNACLE продемонстрировали улучшение качества жизни, связанного со снижением общего балла шкалы респираторного опросника госпиталя Святого Георгия (SGRQ) в сравнении с его исходным уровнем спустя 24 нед. от начала приема ГП/ФФ. На фоне приема ГП/ФФ значительно уменьшилась потребность использования сальбутамола по сравнению с плацебо. Объединенный анализ исследований PINNACLE 1, 2, 4 продемонстрировал возможности ГП/ФФ улучшать вентиляционную функцию легких и снижать риск обострений ХОБЛ по сравнению с монокомпонентами и плацебо. По результатам анализа также не выявлено увеличения количества наиболее часто регистрируемых нежелательных побочных реакций.

A literature review presents the efficacy and safety of the new glycopyrronium bromide/formoterol fumarate (GP/FF) combination in the treatment of patients with chronic obstructive pulmonary disease according to the PINNACLE 1, 2, 3, 4 studies. There are 4 fixed LAMA/LABA combinations which used in world practice, as well as in Russia: vilanterol + umeclidinium bromide, glycopyrronium bromide + indacaterol, olodaterol + tiotropium bromide and aclidinium bromide + formoterol. The GP/FF combination also approved in Russia, is currently present in Global Initiative for Chronic Obstructive Lung Disease (GOLD). A new method of co-suspension delivery via the Aerosphere inhaler has been developed for this combination. The efficacy and safety in GP/FF MDI compared to its monocomponents and tiotropium bromide were assessed in phase III clinical trials PINNACLE 1, 2, 3, 4. The GP/FF combination showed an improvement in the morning and after 2 hours parameters of FEV1 compared to monocomponents and placebo. Data from PINNACLE studies showed an improvement in the quality of life associated with a decrease in compared with the baseline level of the overall score on the scale of the St. George’s Hospital Respiratory Questionnaire (SGRQ) in 24 weeks against those taking GP/FF in contrast to monocomponents and placebo. The use of GP/FF showed a significant reduction in theuse of salbutamol compared with placebo. A pooled analysis of PINNACLE 1, 2, 4 demonstrated that GP/FF improved lung functionand reduced the risk of COPD exacerbations compared with monocomponents and placebo. According to the results of the analysis, there was also no increase in the number of the most frequently recorded side effects.

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