MIDTERM RESULTS OF THE OBSERVATIONAL NON-INTERVENTIONAL CLINICAL STUDY "EVALUATION OF THE EFFECTIVENESS OF THE CARNITINE OROTATE AND BIPHENYLDIMETHYLDICARBOXYLATE COMPLEX IN THE PATHOGENETIC THERAPY OF METABOLIC-ASSOCIATED FATTY LIVER DISEASE: A PROSPEC
Introduction. Metabolic dysfunction-associated fatty liver disease (MAFLD) is a widespread pathology requiring effective treatment approaches. One promising direction is the use of a complex of carnitine orotate and biphenyldimethyldicarboxylate (COC and BDD), which possess antioxidant and hepatoprotective properties.
Materials and methods. As part of the observational, non-interventional, prospective cohort study KASVM-01 [NCT06078722], the impact of COC and BDD on the progression of MAFLD in patients in the Republic of Kazakhstan was investigated. From February 2023 to July 2024, a total of 121 participants from Almaty and Almaty Region were enrolled in the study and received COC and BDD. The observation period lasted 12 months, with an interim analysis conducted on 78 participants who completed a 24-week treatment course. Anthropometric parameters (BMI, waist circumference), liver steatosis and fibrosis levels measured via transient elastography (FibroScan) with CAP, ALT, AST, total cholesterol, triglycerides, and FIB-4 (a non-invasive fibrosis marker) were assessed at baseline and after completing 24 weeks of therapy with COC and BDD.
Results. The interim analysis revealed a statistically significant reduction in ALT levels (from 32.4 to 20.1 U/mL, p<0.001), triglycerides (from 1.4 to 1.3 mmol/L, p=0.007), steatosis grade (from 304 to 283 dB/m, p<0.001), and fibrosis level (from 6.5 to 6.0 kPa, p=0.022). The prevalence of severe steatosis (S3) decreased from 52.7% to 45.7%, whereas mild steatosis (S1, S0) increased to 21.4% and 10%, respectively (p=0.001). The proportion of patients with F3 fibrosis declined from 8.1% to 1.4%, while F2 fibrosis decreased from 27% to 21.4% (p=0.022), indicating an improvement in fibrosis markers. During the observation period, BMI decreased (from 30.4 to 29.8 kg/m²), although the changes were not statistically significant (p=0.214). No significant changes were observed in total cholesterol and FIB-4 levels.
Conclusion. The interim analysis confirmed the effectiveness of COC and BDD in the treatment of MAFLD, demonstrating improvements in biochemical parameters as well as regression of liver steatosis and fibrosis. Further research and validation of these findings in later stages of observation are necessary to assess the final efficacy and long-term safety of the therapy.
Almagul Jumabayeva - MD, MSc, Assistant of the Department of Internal Diseases, JSC “Research Institute of Cardiology and Internal Diseases”, Address: 050000, Republic of Kazakhstan, Almaty, 120 Aiteke Bi street, https://orcid.org/0000-0002-8899-944X e-mail: almusa010@mail.ru, Phone: +7 701 512 2326
Jamilya Kaibullayeva - MD, PhD, Associate Professor, Deputy Chairman of the Board for Scientific, Clinical and Innovative Activities, JSC “Research Institute of Cardiology and Internal Diseases”, Address: 050000, Republic of Kazakhstan, Almaty, 120 Aiteke Bi street, https://orcid.org/0000-0002-0783-4441 e-mail: kaibullaev@mail.ru, Phone: +7 747 105 1195
Aliya Kaisina - MD, Assistant of the Department of Internal Diseases, JSC “Research Institute of Cardiology and Internal Diseases”, Address: 050000, Republic of Kazakhstan, Almaty, 120 Aiteke Bi street, https://orcid.org/0009-0008-6250-1448 e-mail: kasinusa@mail.ru Phone: + 77774132039
Balzhan Nugmanova - MD, Head of Therapy Department No. 1, JSC “Research Institute of Cardiology and Internal Diseases”, Address: 050000, Republic of Kazakhstan, Almaty, 120 Aiteke Bi street, https://orcid.org/0009-0000-0991-7673 e-mail: b.t.nugmanova@mail.ru, Phone: +7 776 201 9955
Zauresh Zhumadilova – MD, Professor of the Department of Internal Diseases and Rheumatology, NсJSC «Semey Medical University», Address: 071400, Republic of Kazakhstan, Abai Region, Semey, 103 Abay Kunanbayev St., https://orcid.org/0000-0001-6211-6154 e-mail: Zauresh.z@mail.ru, Phone: +7 777 153 9910
Ainur Botabayeva - MD, assistant of the Department of Internal Diseases and Rheumatology, NсJSC «Semey Medical University», Address: 071400, Republic of Kazakhstan, Abai Region, Semey, 103 Abay Kunanbayev St., https://orcid.org/0009-0008-9228-7788 e-mail: aibota7878@mail.ru Phone: +7 701 100 2098
Aliya Ualiyeva - Head of the Department of Epidemiology, Biostatistics and Evidence-Based Medicine, Al-Farabi Kazakh National University, Address: 71 Al-Farabi Ave., Almaty, Republic of Kazakhstan, 050040. https://orcid.org/0000-0002-4776-1988 e-mail: aualiyeva9@gmail.com Phone: +7 707 431 6857
Marat Pashimov - Chairman of the Board JSC “Research Institute of Cardiology and Internal Diseases”, Address: 050000, Republic of Kazakhstan, Almaty, 120 Aiteke Bi street, https://orcid.org/0009-0004-9316-9549, e-mail: ncvb-dir@yandex.kz
Gulshahira Kambarova - Chief Physician of the “City Polyclinic No. 6”, Address: 050062, Republic of Kazakhstan, Almaty, microdistrict 4, 3a Altynsarin Ave., https://orcid.org/0009-0006-8099-9097 e-mail: gulya_11@mail.ru, Phone: +7 701 559 5252
Kamka Omarova - Chief Physician of the “City Polyclinic No.5”, Address: 050026, Republic of Kazakhstan, Almaty, 141 Makatayeva Street, https://orcid.org/0000-0002-9313-4774, e-mail: gkkp5@inbox.ru, Phone: +77272333961
Aizhan Muratbekova – MD, Head of the Hepatocenter, “City Polyclinic No. 5”, Address: 050026, Republic of Kazakhstan, Almaty, 141 Makatayeva Street, https://orcid.org/0009-0006-7248-0850, e-mail: ai_zere2014@bk.ru, Phone: +7 747 690 4042
Aliya Balabek - MD, “City Polyclinic No. 5”, Address: 050026, Republic of Kazakhstan, Almaty, 141 Makatayeva Street, https://orcid.org/0009-0009-4560-5939, e-mail: turganbaevy.aaa@mail.ru, Phone: +7 747 427 6626
Assya Yergaliyeva - MD, “City Polyclinic No. 5”, Address: 050026, Republic of Kazakhstan, Almaty, 141 Makatayeva Street, https://orcid.org/0009-0003-5250-9298, e-mail: aaergaliyeva@mail.ru, Phone: +7 778 433 9874
Tamilya Reshidova – MD, Enbekshikazakh Interdistrict Multidisciplinary Hospital, Address: 050026, Republic of Kazakhstan, Enbekshikazakh district, Esik, 336 Abay St., https://orcid.org/0009-0008-3172-4817 e-mail: tamikbashirova@mail.ru, Phone: +7 702 777 7094
Aikerim Saktagan – MD, "Mangistau Regional Multidisciplinary Hospital", Address: 130000, Republic of Kazakhstan, Mangistau region, 26th microdistrict, building No. 53, https://orcid.org/0009-0008-3093-2462, e-mail: Saktagan.aikerim@gmail.com, Phone: +7 775 542 3214
Tatyana Kassymova – MD, "Regional Clinical Hospital" of the Public Health Department of the Turkestan Region, Address: 161200, Republic of Kazakhstan, Turkestan region, Turkestan city, 56b Kozhanov st., https://orcid.org/0009-0005-5581-7725, e-mail: Kassymovatv@gmail.com, Phone: +7 775 226 8143
Guldana Mutaliyeva - MD, Medical center "GastroMed", Address: 160016, Republic of Kazakhstan, Shymkent, 16 Kolhoznaya Street, https://orcid.org/0009-0001-3134-4354, e-mail: gmutalieva@mail.ru, Phone: +7 701 377 3034
Aidana Anuar - MD, Dermatovenerological unit, “Multidisciplinary city hospital No. 3" Akimat of Astana, Address: Z11C8H8, Republic of Kazakhstan, Astana, Saryarka district, 281 Aliya Moldagulova street, https://orcid.org/0009-0000-1694-4565, e-mail: anr.aidana@ya.ru, Phone: +77015516699
Shynar Kudaibergenova - Department of Regulation and Control in the Sphere of Social Protection of the Population of the Republic of Kazakhstan, Address: 040800, Republic of Kazakhstan, Almaty region, Konaev, 41 1st microdistrict, https://orcid.org/0009-0001-7732-5642, e-mail: china_aa@mail.ru, Phone: +7 707 415 3430
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Jumabayeva A., Kaibullayeva J., Kaisina A., Nugmanova B., Zhumadilova Z., Botabayeva A., Ualiyeva A., Pashimov M., Kambarova G., Omarova K., Muratbekova A., Balabek A., Yergaliyeva A., Reshidova T., Saktagan A., Kassymova T., Mutaliyeva G., Anuar A., Kudaibergenova Sh. Midterm results of the observational non-interventional clinical study "Evaluation of the effectiveness of the carnitine orotate and biphenyldimethyldicarboxylate complex in the pathogenetic therapy of metabolic-associated fatty liver disease: a prospective cohort study» // Nauka i Zdravookhranenie [Science & Healthcare]. 2025. Vol.27 (1), pp. 7-14. doi 10.34689/SH.2025.27.1.001Похожие публикации:
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