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Endocrine Abstracts (2016) 43 OC35 | DOI: 10.1530/endoabs.43.OC35

Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk National Research Medical Center, Russian Academy of Sciences.


In recent years non-alcoholic fatty liver disease (NAFLD) has been ascribed to conditions associated with the metabolic syndrome (MS). The high probability of an unfavorable course of NAFLD combined with MS symptoms dictates the need to search for some therapeutic approaches in the treatment of patients, given the similarity of the development mechanisms of both MS and NAFLD, i.e. the insulin-resistance. One of the drugs that reduces insulin resistance is Subetto (Subetta, NPF Materia Medica Holding, Russia), that provides antibodies to the C-terminal fragment of the beta-subunit of the insulin receptor and the endothelial NO synthase.

A prospective clinically controlled study was carried out/performed, in which 20 men (average age: 40.05±1.25 years) with ultrasound signs of NAFLD and a verified MS were examined. The research was carried out in accordance with the Declaration of Helsinki. The research lasted 3 months, during which all patients took the drug Subetto 3 times a day after meals. At baseline and after 3 months of treatment a physical examination was performed, together with the evaluation of carbohydrate metabolism (including determination of insulin and calculation of insulin resistance index HOMA-R) and the content of aspartate transaminase (AST) and alanine transaminase (ALT). Ultrasound examination of the liver was done on the scanner ClearVue 550. The results were processed according to the methods of variation statistics.

During the treatment with Subetto, 75% of the patients returned to normal levels of fasting plasma glucose, and the postprandial blood glucose levels decreased from 7.60±0.16 to 6.75±0.21 mmol/l. A decrease in the concentration of basal insulin by 28.7% (P>0.05) was recorded, which resulted in a significant reduction of HOMA-R index from 2.42±0 to 1.49±0. The number of patients with insulin resistance decreased from 100% to 40%.

Evaluation of the cytolytic syndrome showed significant reduction in the ALT activity (from 48.16±5.18 to 30.39±4.09 U/l, P<0.01) and AST (from 39.74±3.03 to 29.35±4.09 U/l, P<0.01), which is indicative of improvement of the functional state of the liver among the patients with NAFLD. Treatment with Subetto also positively affected the size of the liver: the vertical side level size of the right lobe of the liver decreased from 159.90±3.62 to 150.20±2.79 mm and cranio-caudal size of the left lobe - from 83.80±8.37 mm to 78.60±5.74 mm (P>0.05). For patients with NAFLD and MS, treatment with Subetto (Subetta, NPF Materia Medica Holding, Russia) contributed to a relief of the key manifestations of metabolic disorders, coupled with a decrease of the severity of the cytolytic syndrome, a reduction of the aminotransferase activity, and a decrease in liver size. In addition, a high compliance to the treatment among the patients was reported.

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