Safety and tolerability of Aviandr (maritupirdine) in long-term therapy of generalized anxiety disorder: results of a 36-week post-marketing observational study

Long-term therapy is necessary for the prevention of relapses of generalized anxiety disorder (GAD), and adherence to it may be hindered by the development of adverse events (AEs). The new domestic drug Aviandr (maritupirdine) has shown efficacy and good tolerability in the treatment of GAD in clinical trials. Objective: to evaluate the safety and tolerability profile of long-term (36-week) GAD therapy with Aviandr (maritupirdine) in real-world clinical practice. Material and methods. An open-label, non-comparative prospective study included 126 patients over 18 years of age with an established diagnosis of GAD. The frequency and severity of AEs, the dynamics of daytime sleepiness on a visual analogue scale (VAS), the presence of with-drawal syndrome, and tolerability features in special patient groups (elderly individuals, patients with somatic comorbidity) were assessed. Results. The vast majority of patients (98.4%) completed the 36-week course of therapy; no patient discontinued the drug due to AEs. Drug-related AEs were registered in 13.49% of patients, predominantly mild in severity (73.1%). The most common AE was somnolence (5.56%), but no clinically significant sedation was noted: the VAS daytime sleepiness score decreased significantly from 39.72±26.29 to 17.73±17.23 by week 36 (p<0.001). No cases of initial worsening of anxiety, sexual dysfunction, weight gain, or Q–T interval prolongation were recorded. No with-drawal syndrome was present 4 weeks after drug discontinuation. In patients aged 65 years and older and in individuals with somatic comorbidity, the safety profile did not differ from the general population. Conclusion. Aviandr demonstrates a high safety and tolerability profile in long-term GAD therapy. The absence of sedation, worsening of anxiety, sexual dysfunction, and withdrawal syndrome ensures high adherence to treatment and makes the drug a safe agent of choice for elderly patients and individuals with concomitant somatic pathology.