Efficacy and safety of non-immunogenic staphylokinase in the ischemic stroke in real-world clinical practice in the Sverdlovsk region

Abstract

To compare the efficacy and safety of non-immunogenic staphylokinase (Fortelysine) and alteplase in patients with ischemic stroke (IS) in real-world clinical practice. A retrospective, observational, non-interventional study of data the register of the Territorial Compulsory Health Insurance Fund was conducted. The proportion of patients with a favorable outcome, the degree of disability at discharge from the hospital, the duration of hospitalization, the proportion of lethal outcome in the groups of Fortelysine and alteplase were evaluated. The effect of the Rankin scale points at the hospitalization, the choice of a medical organization, the month of hospitalization, the choice of a thrombolytic on achieving a favorable outcome was determined. The data of 1238 patients from 26 hospitals of the Sverdlovsk region were included. There were no statistically significant differences in the proportion of a favorable outcome between the groups of Fortelysine and alteplase (26% and 25% respectively, p=0.845). Mediana of duration of hospitalization in the Fortelysine group was one day less, which is statistically significant compared to the alteplase group (9 [7;12] and 10 [7;13] respectively, p<0.001). There were no differences in the frequency of mortality (11% and 13% respectively, p=0.331). The hospital, the year and month of hospitalization, the level of disability at the baseline have a statistically significant effect on the outcome of hospitalization. The choice of a thrombolytic drug did not have a statistically significant effect on the frequency of favorable outcome. The comparable efficacy and safety of Fortelysine and alteplase in IS has been proven in clinical study and confirmed by real-world clinical practice.