Statutory regulation of obesity pharmacotherapy: analysis of domestic and international approaches
Year: 2025
Type: article
Abstract: Introduction. The article provides a comparative analysis of national regulatory documents issued by the Ministry of Health (MOH) of Ukraine and international clinical guidelines governing the use of medicinal products by INN (International Nonproprietary Name) for obesity treatment. Official guidelines from NICE (UK), EMA and EASO (EU), FDA (USA), and the Spanish GIRO manual were reviewed. It was established that in Ukraine only two INN medicinal products are recommended for clinical use: liraglutide and orlistat. In contrast, international approaches endorse a broader range of pharmacological agents, including semaglutide, tirzepatide, naltrexone/bupropion, phentermine/topiramate, and setmelanotide. Purpose. to compare domestic and international regulatory recommendations and standards for modern obesity pharmacotherapy. Materials and methods. The study used the documentary-analytical method, bibliographic analysis, and the method of systematisation and generalisation of data from regulatory sources. Results. The results of the study indicate that modern obesity pharmacotherapy is primarily based on preparations with mechanism of action as glucagon-like peptide-1 (GLP-1) receptor agonists and GLP-1/glucose-dependent insulinotropic polypeptide (GIP) co-agonists. This group includes such medicinal products as semaglutide, liraglutide, and tirzepatide, which show high efficacy in reducing body weight (by 8% to 21%) and improving metabolic parameters. These preparations also reduce the risk of cardiovascular complications, which makes them particularly valuable to patients with concomitant type 2 diabetes mellitus. Additionally, other pharmacological groups are used in obesity treatment, such as lipase inhibitors (orlistat), naltrexone/bupropion combinations, sympathomimetics (phentermine), and others, which are applied in the absence of the possibility of prescribing incretin mimetics or in combination with them. Comparative analysis of international and domestic recommendations shows that in Ukraine, the officially approved only two preparations for obesity treatment – liraglutide and orlistat, whereas in Europe, the USA and the UK, the list of affordable preparations is much broader and includes semaglutide, tirzepatide, bupropion/naltrexone combination, and phentermine/topiramate. It shows a certain lag of the Ukrainian regulatory framework behind global standards, which limits the therapeutic capabilities of clinicals. At the same time, as of 2025, semaglutide was registered in Ukraine, which partially addresses this gap. A significant aspect of the research is the analysis of the role of pharmacists in obesity treatment. While in Europe and the USA, pharmacists are actively involved in therapy monitoring, patient counselling, and side effect prevention, in Ukrainian clinical guidelines their participation is limited, reducing the effectiveness of a comprehensive approach to treatment. This is particularly relevant under martial law, when pharmaceutical care could significantly improve the safety and efficacy of therapy for civilians and military personnel. Conclusions. Based on the analysis results, it is established that there are differences between national and international approaches to obesity pharmacotherapy, particularly among recommended INNs. Only two medications are approved in Ukraine, while leading international guidelines recommended a wider range of medicinal products.
Authors: A. V. Kabachna, T. O. Shapoval, O. P. Shmatenko, A. M. Solomennyi, V. O. Tarasenko, O. V. Pleshkova, T. M. Krasnianska
Language: English
Subfield: Pharmacology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4415020119