Objective. To evaluate the efficacy and safety of non-benzodiazepine anxiolytic maritupirdine (Aviandr) in patients with panic disorder. Material and methods. In a multicenter, randomized, double-blind, placebo-controlled study with an open-label comparison, 288 patients with moderate PD were assigned to receive Aviandr 40 mg/day (n=144), placebo (n=72), or paroxetine 40 mg/day (n=72). The treatment duration was 12 weeks. Clinical and psychopathological, psychometric methods and statistical analysis were used. The Panic Disorder Severity Scale (PDSS), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), the Clinical Global Impression Scale (CGI), the Visual Analog Scale (VAS) of daytime sleepiness and the Sheehan Disability Scale (SDS) were used for a standardized assessment of the state change. The primary endpoint was the change in Panic Disorder Severity Scale (PDSS) total score at week 12. Results. The PDSS score reduction in the Aviandr group (–4.99) was statistically and clinically significantly greater than in the placebo group (–2.28; p=0.047). The drug demonstrated a rapid onset of action, with significant improvement beginning at week 2. Aviandr’s efficacy on secondary endpoints (SIGH-A and CGI) was also superior to placebo. The need for symptomatic hydroxyzine therapy was significantly lower in the Aviandr group. The safety profile was favorable, with adverse event rates comparable to placebo (44.44%) and lower than in the paroxetine group (50%). No serious adverse events were recorded. Conclusion. Aviandr demonstrated statistically significant superiority over placebo, rapid onset of action, and a favorable safety profile, making it a promising treatment option for panic disorder.
Vasyuta et al. (Tue,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: