Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 14, 2021; 27(10): 959-975
Published online Mar 14, 2021. doi: 10.3748/wjg.v27.i10.959
Ursodeoxycholic acid as a means of preventing atherosclerosis, steatosis and liver fibrosis in patients with nonalcoholic fatty liver disease
Maria Nadinskaia, Marina Maevskaya, Vladimir Ivashkin, Khava Kodzoeva, Irina Pirogova, Evgeny Chesnokov, Alexander Nersesov, Jamilya Kaibullayeva, Akzhan Konysbekova, Aigul Raissova, Feruza Khamrabaeva, Elena Zueva
Maria Nadinskaia, Vladimir Ivashkin, Khava Kodzoeva, Department of Propaedeutics of Internal Diseases, Gastroenterology and Hepatology, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia
Marina Maevskaya, Vasilenko Clinic of Internal Diseases Propedeutics, Gastroenterology and Hepatology, University Clinical Hospital №2, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia
Irina Pirogova, LLC MC “Lotus”, Center for Gastroenterology and Hepatology, Chelyabinsk 454092, Russia
Evgeny Chesnokov, Department of Hospital Therapy with the Course of Endocrinology and Clinical Pharmacology, Tyumen State Medical University, Tyumen 625003, Russia
Alexander Nersesov, Jamilya Kaibullayeva, Department of Gastroenterology, S. Asfendiyarov Kazakh National Medical University, Almaty 050000, Kazakhstan
Akzhan Konysbekova, Functional and Ultrasound Diagnostics, Scientific and Research Institute of Cardiology and Internal Diseases, Almaty 050000, Kazakhstan
Aigul Raissova, Department of Internal Diseases, Scientific and Research Institute of Cardiology and Internal Diseases, Almaty 050000, Kazakhstan
Feruza Khamrabaeva, Faculty of Therapy, Tashkent Institute of Advanced Medical Studies, Tashkent 100007, Uzbekistan
Elena Zueva, Department of Therapy № 1 with Training General Practitioners, Tashkent Medical Academy, Tashkent 100109, Uzbekistan
Author contributions: Nadinskaia M, Maevskaya M, and Ivashkin V contributed equally to this work and should be considered as co-first authors; Maevskaya M, and Ivashkin V conceived the design; Nadinskaia M and Kodzoeva Kh analyzed the results; Nadinskaia M, and Maevskaya M wrote the original draft; Kodzoeva Kh, Pirogova I, Chesnokov E, Nersesov A, Kaibullayeva J, Konysbekova A, Raissova A, Khamrabaeva F, and Zueva E conducted the study; all the authors revised the manuscript and approved the final version.
Institutional review board statement: The study was reviewed and approved by the Russian Scientific Liver Society Review Board. Approval No. 003.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Maria Yu. Nadinskaia, in 2015-2019 provided consulting services for the PRO.MED.CS Marketing. Marina V. Maevskaya in 2015-2019 provided consulting services for the PRO.MED.CS Marketing. Vladimir T. Ivashkin in 2015-2019, provided consulting services for the PRO.MED.CS Marketing. Feruza I. Khamrabaeva in 2015-2019, provided consulting services for the PROMEDCSCA. Elena B. Zueva, in 2015-2019, provided consulting services for the PROMEDCSCA. Alexander V. Nersesov, in 2018-2019, provided consulting services for the PROMEDCSCA. Aigul M. Raissova, in 2018-2019, provided consulting services for the PROMEDCSCA. Khava B. Kodzoeva declares that there are no conflicts of interest. Irina Yu. Pirogova declares that there are no conflicts of interest. Evgenii V. Chesnokov declares that there are no conflicts of interest. Jamilya A. Kaibullayeva declares that there are no conflicts of interest. Akzhan Konysbekova declares that there are no conflicts of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at liver.orc@mail.ru. Informed consent was not obtained but the presented data are anonymized and risk of identification is low.
CONSORT 2010 statement: The authors confirm that the manuscript was prepared according to the CONSORT 2010 checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Marina Maevskaya, MD, Professor, Vasilenko Clinic of Internal Diseases Propedeutics, Gastroenterology and Hepatology, University Clinical Hospital №2, Sechenov First Moscow State Medical University (Sechenov University), 8/2, Trubetskaya str., Moscow 119991, Russia. liver.orc@mail.ru
Received: December 3, 2020
Peer-review started: December 3, 2020
First decision: December 11, 2020
Revised: December 30, 2020
Accepted: February 24, 2021
Article in press: February 24, 2021
Published online: March 14, 2021
Processing time: 97 Days and 16 Hours
Core Tip

Core Tip: An open-label, multicenter, international noncomparative trial demonstrated the effect of ursodeoxycholic acid (UDCA) on hepatic steatosis and fibrosis, atherogenesis, and atherosclerotic cardiovascular disease risk in 174 ultrasound-diagnosed nonalcoholic fatty liver disease patients who received 15 mg/kg/d UDCA for 6 mo and were prescribed lifestyle modifications with diet and exercise. UDCA had a bidirectional positive effect on the liver and cardiovascular system in patients with and without > 5% weight loss: It improved liver enzymes, lipid profiles, and hepatic steatosis in addition to improving carotid intima-media thickness and atherosclerotic cardiovascular disease risk.