Use of sodium-glucose co-transporter-2 inhibitors from clinical trial results to practical application in Russia

Abstract

In clinical trials of drugs, including sodium-glucose co-transporter-2 inhibitors (SGLT2), the main reason for the discontinuation of the therapy are side effects. However, there are additional factors that affect the discontinuation of the therapy in real clinical practice. This paper presents assessment of adverse events against the background of SGLT2 therapy with empagliflozin, identification of risk factors for these phenomena, and analysis of the reasons for discontinuation of SGLT2 therapy in real clinical practice. The study included 86 patients with type 2 diabetes mellitus, who were prescribed empagliflozin SGLT2 for the first time. During the trial, 24 (27.9%) cases of side effects were reported: infection in the genitourinary tract – 13 (15.1%) cases, hypoglycemia – 7 (8.1%) cases, and hypotension – 4 cases (4.7%). In general, the risk factors for adverse events were female gender, BMI ≥ 30 kg/m2 and reduced estimated glomerular filtration rate (eGFR<60 mL/min/1.73m2). The empaglyflosin therapy was discontinued in 37.1% of patients for the following reasons: the development of side effects – 11.6%, lack of efficacy of the therapy – 8.1%, the cost of the drug – 13.9%, other reasons – 3.5%. Thus, in real clinical practice, not only the development of side effects, but also socio-economic factors play an important role in supporting medication adherence.