ADMINISTRATION OF CORVITIN AS AN OFF-LABEL AGENT FOR PHARMACOLOGICAL CORRECTION OF METABOLIC SYNDROME
Keywords:Corvitin, metabolic syndrome, off-label
Nowadays metabolic syndrome is a noninfectious pandemic of the ХХІ century. Therefore search of effective pharmacological agents for its pharmacological correction is an urgent issue of modern medicine and pharmaceutical community. At the same time, today off-label administration of medicines (for an unapproved indication) has become widely used. This approach is based on new determined pharmacological effects of drugs unknown before. These effects were not studied during the primary development of a pharmacological agent, but they were found after its registration and appearance at the pharmaceutical market.
The article presents the results of the experimental study of metabolism correcting properties of the drug «Corvitin®» (a frozen-dried (lyophilizied) powder to prepare solution for intravenous injections in the dose of 0,5 g in bottles by Borshchagivsky Chemical-Pharmaceutical Plant, Joint-Stock Company, Kyiv, Ukraine under conditions of experimental metabolic syndrome on golden or Syrian hamsters (Mesocricetus auratus).
The control pathology was simulated by means of Changiz Taghibiglou et al. method. During 14 days the following groups of animals: 2 (control pathology), 3 (control pathology + Corvitin) and 4 (control pathology + Metformin) were kept on the diet 60 % changed into fructose in the form of dry feed and drink (further — 60 % fructose diet). Beginning with the 15th day of the experiment with underlying 60 % fructose diet the groups 3 and 4 began to receive Corvitin under study and reference Metformin during 10 days. During this whole time the animals from group 2 (control pathology) were kept on 60% fructose diet, and the animals from group 1 (intact control) were kept of the standard vivarium forage getting a balanced diet containing proteins, fats, carbohydrates, essential trace elements and vitamins. The effects of Corvitin and Metformin produced on the parameters of carbohydrate metabolism were studied by the assessment of glucose and insulin concentration in the blood serum, and calculation of HOMA-IR. The following parameters of lipid type were examined: the level of the whole lipids, cholesterol, apolipoprotein В (apoB) and triglycerides (TG). The following cytokines were considered as markers of pro-inflammatory status: ІL-1 β, ІL-6, TNF-α.
The results of the study conducted enabled to establish a favorable Corvitin effect produced on the course of metabolic syndrome found under conditions of experimental simulation of the pathology in hamsters. All the 102 Проблеми ендокринної патології №1, 2021 Експериментальні дослідження above substantiates reasonability to indicate off-label administration of the drug in therapy of metabolic syndrome with the aim to increase efficacy and safety of its treatment. Moreover, the results obtained are the basis for wider pharmacodynamics of the drug «Corvitin®» and introduction of certain changes into the instruction of its medical administration.
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