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http://repository.pdmu.edu.ua/handle/123456789/21443
Назва: | A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease |
Автори: | Romero-Gómez, Manuel Lawitz, Eric Shankar, R Ravi Chaudhri, Eirum LH Lam, Raymond Skrypnyk, Igor Bassan, Isaac Скрипник, Ігор Миколайович |
Дата публікації: | 22-чер-2023 |
Видавець: | Elsevier |
Бібліографічний опис: | A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease / M. Romero-Gómez, E. Lawitz, I. Skrypnyk [et al.] // Journal of Hepatology. – 2023. – Vol. 78. – P. 1–10. |
Короткий огляд (реферат): | Methods: This was a phase IIa, randomized, active-comparator-controlled, parallel-group, open-label study. A magnetic resonance imaging-estimated proton density fat fraction assessment was performed to determine LFC at screening and Week 24. Participants with an LFC of >− 10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks. Participants were stratified according to the concurrent diagnosis of type 2 diabetes mellitus (T2DM). Both drugs were titrated to the target dose over an 8-week time period. The primary efficacy endpoint was relative reduction from baseline in LFC (%) after 24 weeks of treatment. Results: Among 145 randomized participants (efinopegdutide n = 72, semaglutide n = 73), 33.1% had T2DM. At baseline, mean BMI was 34.3 kg/m2 and mean LFC was 20.3%. The least squares (LS) mean relative reduction from baseline in LFC at Week 24 was significantly (p <0.001) greater with efinopegdutide (72.7% [90% CI 66.8–78.7]) than with semaglutide (42.3% [90% CI 36.5–48.1]). Both treatment groups had an LS mean percent reduction from baseline in body weight at Week 24 (efinopegdutide 8.5% vs. semaglutide 7.1%; p = 0.085). Slightly higher incidences of adverse events and drug-related adverse events were observed in the efinopegdutide group compared with the semaglutide group, primarily related to an imbalance in gastrointestinal adverse events. |
Ключові слова: | Non-alcoholic fatty liver disease steatosis hepatic lipogenesis |
DOI: | https://doi.org/10.1016/j.jhep.2023.05.013 |
URI: | http://repository.pdmu.edu.ua/handle/123456789/21443 |
Розташовується у зібраннях: | Наукові праці. Кафедра внутрішньої медицини № 1 |
Файли цього матеріалу:
Файл | Опис | Розмір | Формат | |
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a_phase_IIa_active_comparator_controlled.pdf | 809,34 kB | Adobe PDF | Переглянути/Відкрити |
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