The results of phase III multicenter open randomized controlled study REM-Chol-III-16 in patients with intrahepatic cholestasis syndrome caused by chronic diffuse liver diseases
- 作者: Stel'makh V.1, Kovalenko A.2, Popova V.3, Uspenskiy Y.4, Morozov V.5, Belikova T.6, Rafalskiy V.7, Antonova E.8
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隶属关系:
- Mechnikov North-Western State Medical University
- Golikov Scientific Clinical Center of Toxicology
- Medical center "Reavita Med SPb"
- Saint Petersburg State Paediatric Medical University
- Medical company "Hepatologist"
- Togliatti City Clinical Hospital №1
- Immanuel Kant Baltic Federal University
- "Modern Medical Technologies" Clinic
- 期: 卷 93, 编号 12 (2021)
- 页面: 1470-1476
- 栏目: Original articles
- URL: https://journals.rcsi.science/0040-3660/article/view/96444
- DOI: https://doi.org/10.26442/00403660.2021.12.201266
- ID: 96444
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Aim. To assess the safety and efficacy of Remaxol®, solution for infusion, compared with parenteral form of S-adenosyl-L-methionine, in the treatment of patients with intrahepatic cholestasis syndrome accompanying chronic diffuse liver diseases of various etiology.
Materials and methods. In a multicenter open-label comparative study of the safety and efficacy of Remaxol® (inosine + meglumine + methionine + nicotinamide + succinic acid) 317 patients aged 18 to 65 years were randomized into 2 groups: patients of the experimental group (n=168) received intravenous Remaxol®, solution for infusion, 400 ml, and patients of the control group (n=149) – Heptral® (S-adenosyl-L-methionine) 800 mg. The duration of treatment was 10 days. The primary efficacy endpoint was the proportion of patients who responded to therapy, as demonstrated by dynamics of laboratory parameters of liver functional status: decrease in gamma glutamyl transpeptidase level by ≥40%, and/or alkaline phosphatase level by ≥30%, and/or decrease total bilirubin level by ≥30% from baseline by the end of the treatment course.
Results. The proportion of responders was 51% in the Remaxol® group vs. 44.9% in the Heptral® group (p=0.303); the lower limit of the one-sided 95% confidence interval for the difference in the proportions of responders was -4.01%, which exceeds the non-inferiority margin pre-defined by the study protocol, thus, the non-inferiority hypothesis was proven, i.e. Remaxol at a dose of 400 ml/day demonstrates similar efficacy to Heptral at a dose of 800 mg/day in patients with intrahepatic cholestasis syndrome associated with chronic diffuse liver diseases. Similar positive trends in the levels of transaminases, total bilirubin and the severity of pruritus were revealed in both treatment groups. We did not reveal statistically significant between-group differences in the frequency of adverse events definitely related to the study treatment.
Conclusion. Administration of Remaxol® as a part of the pathogenetic therapy of patients with intrahepatic cholestasis syndrome who need hepatoprotection is justified.
作者简介
Viktoriia Stel'makh
Mechnikov North-Western State Medical University
编辑信件的主要联系方式.
Email: lednik-07@mail.ru
ORCID iD: 0000-0001-7942-1227
канд. мед. наук, доц. каф. внутренних болезней, клинической фармакологии и нефрологии
俄罗斯联邦, Saint PetersburgAleksey Kovalenko
Golikov Scientific Clinical Center of Toxicology
Email: lednik-07@mail.ru
ORCID iD: 0000-0003-3695-2671
д-р биол. наук, канд. хим. наук, вед. науч. сотр.
俄罗斯联邦, Saint PetersburgVeronika Popova
Medical center "Reavita Med SPb"
Email: lednik-07@mail.ru
ORCID iD: 0000-0001-8235-5654
канд. мед. наук, ген. дир.
俄罗斯联邦, Saint PetersburgYury Uspenskiy
Saint Petersburg State Paediatric Medical University
Email: lednik-07@mail.ru
ORCID iD: 0000-0001-6434-1267
д-р мед. наук, проф., зав. каф. факультетской терапии им. проф. В.А. Вальдмана
俄罗斯联邦, Saint PetersburgViacheslav Morozov
Medical company "Hepatologist"
Email: lednik-07@mail.ru
ORCID iD: 0000-0002-4451-7891
д-р мед. наук, проф., дир.
俄罗斯联邦, SamaraTatiana Belikova
Togliatti City Clinical Hospital №1
Email: lednik-07@mail.ru
ORCID iD: 0000-0002-8662-9373
зам. глав. врача
俄罗斯联邦, TogliattiVladimir Rafalskiy
Immanuel Kant Baltic Federal University
Email: lednik-07@mail.ru
ORCID iD: 0000-0002-2503-9580
д-р мед. наук, проф., дир. Центра клинических исследований
俄罗斯联邦, KaliningradElizaveta Antonova
"Modern Medical Technologies" Clinic
Email: lednik-07@mail.ru
ORCID iD: 0000-0002-5455-299X
врач-терапевт, клинический фармаколог
俄罗斯联邦, Saint Petersburg参考
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