Analysis of trends in the positioning of pharmaceutical drugs of the SGLT-2 class of gliflozin derivatives at the pharmaceutical market and the application prospects
DOI:
https://doi.org/10.24959/sphhcj.23.282Abstract
Aim – is to analyze trends in the use and positioning of pharmaceuticals of the class of gliflozin derivatives on the Ukrainian pharmaceutical market.
Materials and methods. In the conducted research, the methods of systematic and comparative analysis, generalization, statistical processing and synthesis were used in determining the projected perspectives, tabular and graphic means of presenting the results. To implement the goal and objectives of the research, software and electronic resources of ATX (Anatomical-Therapeutically-Chemical), ATC (Anatomical Therapeutically Chemical Classification System), BSC (Biopharmaceutical Classification System), Vidal, Compendium, and the State Register of Medicinal Products of Ukraine were used.
Results of the research. The results of a systematic analysis of application trends and a comparative analysis of marketing research on the positioning of pharmaceuticals of the class of gliflozin derivatives on regulated markets and the Ukrainian pharmaceutical market are presented. A steady trend in the positioning of the number of appointments in the segments of mono and combined drugs and the number of sales on regulated markets was revealed. It is established that as of the end of 2022, the total number of pharmaceuticals from API class SGLT-2 pharmaceutically acceptable of gliflozin derivatives in the form of solid dosage forms, which are positioned on regulated markets and pharmaceutical campaign research on the pharmaceutical development of new dosage forms of mono and combined drugs is 35, the number of registered pharmaceutical drugs in Ukraine is 4 mono and 2 combined drugs. The segment of this group of drugs - mono and combined drugs - has been systematized, according to the ATX classification by active substances - API - pharmaceutically acceptable salts of gliflozin derivatives on regulated markets and on the pharmaceutical market of Ukraine.
Conclusions. The analysis of positioning on regulated markets and statistics of R&D research of pharmaceutical companies for the development of new dosage forms of mono and combined drugs provides grounds to generalize and conclude that SGLT-2 inhibitors are the newest and promising class of antidiabetic drugs, which, according to evidence-based medicine, are used in combination with with insulin and other antidiabetic drugs in the treatment of diabetes mellitus (DM) of I and II types, in combined regimens with metformin and DPP-4 inhibitors, as well as in combinations of all three and TZD drugs. SGLT-2 inhibitors are the second largest group of antidiabetic agents by the volume of clinical trials, which is 12%.
Recommended for use by FDA regulatory authorities, EMA is an API of the SGLT-2 class of pharmaceutically acceptable derivatives of gliflozin: canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, tofogliflozin, sotagliflozin, as well as pharmaceutically acceptable salts; remogliflozin etabonate; sergliflozin etabonate.
It has been established that SGLT-2 API drugs of pharmaceutically acceptable derivatives of gliflozin have a constant trend of positioning the number of appointments in the segments of mono and combined drugs and the number of sales on regulated markets, the total amount is 35 in the form of solid dosage forms. Distribution by volume of sales of solid dosage forms of pharmaceutical preparations with API class SGLT-2 of pharmaceutically acceptable of gliflozin derivatives is: tableted monopreparations – 59.2%; combined – 37.2%; mono preparations, hard capsules - 3.6%.
The number of registered pharmaceutical drugs in Ukraine is 4 mono and 2 combined drugs, the level of prices from a pharmacoeconomic point of view, according to the results of price comparison of other antihyperglycemic drugs, are not affordable for Ukrainian patients who need systemic use. Therefore, the increase in the range of SGLT-2 class API drugs of pharmaceutically acceptable gliflozin derivatives on the Ukrainian pharmaceutical market and competitive manufacturers will contribute to the availability of use for the treatment of DM in Ukrainian patients.
Key words: trends; positioning; application; pharmaceutically acceptable derivatives of gliflozin; drug support; best practice; evidence-based medicine; rational pharmacotherapy.
References
World Health Organization. (2022) Fact Sheet Diabetes. URL: https://www.who.int/en/news-room/fact-sheets/detail/diabetes.Accessed (Access date:12.08.2022)
PhRMA (2019). Medicines in Development for Diabetes and Related Conditions. URL: https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/M-O/MID-Diabetes-Drug-List-2019.pdf (Access date: 12.08.2022)
Garcia-Ropero, A., Badimon, J. J.: (2018) The pharmacokinetics and pharmacodynamics of SGLT2 inhibitors for type 2 diabetes mellitus: the latest developments. Expert Opinion on Drug Metabolism and Toxicol, 14(12), 1287-1302.
Hsia, D.S., Grove, O., Cefale, W.T. (2017) An update on SGLT2 inhibitors for the treatment of diabetes mellitus. HHS Public Access, 24(1), 73-79.
Dahlen, A.D., Dashi, G., Maslov, I., Attwood, M.M., Jonsson, J., Trukhan, V., Schioth, H.B. (2021) Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Drugs in Clinical Trials and Global Sales. Front. Pharmacology, Vol.12,1–16.
Singh, M., Kumar, A. (2018) Risks Associated with SGLT2 Inhibitors: An Overview, Current Drug Safety,13(2), 2–3.
Tiwari, S.S., Wadher, S.J., Fartade, S.J.,Vikhar, C.N. (2019) Gliflozin a new class for type-II diabetes mellitus: an overview. Int J Pharm Sci & Res., 10 (9), 4070-4077.
Dapagliflozin: MedlinePlus Drug Information. URL: https://medlineplus. gov/ druginfo/meds/a614015.html
Macisaac, R.J., Lee, M.H. (2018) Empagliflozin as adjunctive therapy for type 1 diabetes. Ann Transl Med., 6(S-2),134.
Yang, J. (2018) Ertugliflozin for treatment of patients with Type 2 diabetes mellitus. Expert Review of Clinical Pharmacology, 11(8),747-753.
Yasuo, T., Masahiro, T., Masayuki, S., Ryoji, G., Kohei, K. (2017) Efficacy and safety of tofogliflozin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy (J‐STEP/INS): Results of a 16‐week randomized, double‐blind, placebo‐controlled multicentre trial. Diabetes Obesity and Metabolism. Jour of Pharmacology and Therapeutics, 19(10), 1397-1407.
Sims H., Smith K.H., Bramlage P., Minguet J. (2018) Sotagliflozin: a dual sodium-glucose cotransporter-1 and -2 inhibitors for the management of Type 1 and Type 2 diabetes mellitus. Diabetic Medicine, 35(8),1037-1048.
Downloads
Published
Issue
Section
License
Copyright (c) 2023 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
