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No. 3 (2024)

ORIRGINAL RESEARCH

A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Aviandr® in the Treatment of Generalized Anxiety Disorder

Published 2024-09-30

  • M.A. Morozova
    • ,
  • T.P. Safarova
    • ,
  • L.Ya. Gluskina
    • ,
  • N.A. Penchul
    • ,
  • L.N. Kasimova
    • ,
  • I.I. Zaiarnaia
    • ,
  • Yu.O. Boychevskaya
    • ,
  • O.Yu. Shiryaev
    • ,
  • M.K. Reznikov
    • ,
  • O.A. Bukhanovskaya
    • ,
  • D.C. Mavani
    • ,
  • M.A. Reutova
    • ,
  • V.A. Nekrasov
    • ,
  • D.S. Gorchakov
    • ,
  • K.V. Balakin
    • ,
  • A.S. Tarakanova
    • ,
  • E.V. Yakubova
    • ,
  • A.V. Ivaschenko
    • ,
  • A.A. Ivaschenko

M.A. Morozova
Federal State Budgetary Scientific Institution “Mental Health Research Center”

T.P. Safarova
Federal State Budgetary Scientific Institution “Mental Health Research Center”

L.Ya. Gluskina
St. Petersburg State Budgetary Healthcare Institution “Psychiatric Hospital No. 1 named after P.P. Kashchenko”

N.A. Penchul
State Public Health Institution “Leningrad Regional Mental Health Center”

L.N. Kasimova
State Budgetary Healthcare Institution of the Nizhny Novgorod region “Clinical Psychiatric Hospital No. 1 of Nizhny Novgorod”

I.I. Zaiarnaia
State Budgetary Clinical Healthcare Institution of the Yaroslavl Region “Yaroslavl Regional Psychiatric Hospital”

Yu.O. Boychevskaya
Center for Professional Therapy LLC

O.Yu. Shiryaev
LION-MED LLC

M.K. Reznikov
Medical practice LLC

O.A. Bukhanovskaya
Scientific Center for Treatment and Rehabilitation “Phoenix“

D.C. Mavani
Medical center “NOVA VITA”

M.A. Reutova
Granat MC LLC

V.A. Nekrasov
Diagnostic and rehabilitation center “Praximed” LLC; Federal State Budgetary Educational Institution of Higher Education “North-Western State Medical University named after I.I. Mechnikov”

D.S. Gorchakov
iPharma LLC

K.V. Balakin
ChemRar RDI LLC

A.S. Tarakanova
ChemRar RDI LLC

E.V. Yakubova
Avineuro LLC

A.V. Ivaschenko
ChemDiv Inc.

A.A. Ivaschenko
ChemRar High-Tech Center

Abstract

Background. The development of new anxiolytic drugs is an important problem, despite the wide range of drugs available for the treatment of generalized anxiety disorder (GAD). This article presents the results of the clinical trial (phase III) of the new drug Aviandr® for the treatment of GAD.

Methods. The primary objective of this study was to evaluate the efficacy of Aviandr® compared to placebo based on changes in the total score on the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) after 8 weeks of treatment in patients with GAD. An additional objective was to evaluate the various efficacy and safety parameters of Aviandr® compared to placebo in patients with GAD during the 8-week study period and during 24 weeks of subsequent treatment with Aviandr® in the open-label long-term treatment period and 4 weeks after the end of treatment.

Results. The study included 160 patients, who were randomised in a 3:1 ratio to two treatment groups: group 1 (n = 121) received Aviandr® 20 mg twice a day, group 2 (n = 39) — placebo 1 tablet twice a day. Analysis of the data for the primary endpoint showed a statistically significant mean change in total SIGH-A score of –11.97 ± 7.60 in the Aviandr® group and –8.21 ± 6.20 in the placebo group after 8 weeks of treatment (p = 0.006, difference between groups was assessed using Student’s T-test). Positive dynamics were also demonstrated for most secondary efficacy parameters. Patients were followed for 4 weeks after completion of therapy. When Aviandr® was discontinued after a period of long-term use (up to 32 weeks), there was no deterioration in the patients' condition, and a statistically significant improvement continued on the main study scales (SIGH-A; Montgomery — Asberg Depression Rating Scale (MADRS); Clinical Global Impression — Severity scale (CGI-S); Clinical Global Impression — Improvement scale (CGI-I); Sheehan Disability Scale (SDS)).

Conclusion. A study of Aviandr® demonstrated its efficacy against the psychological and somatic symptoms of anxiety in GAD, making it a promising drug for the treatment of this disorder during the initial and continued periods of therapy. A favorable safety profile of the drug was demonstrated in long-term treatment period (up to 32 weeks). After completion of treatment, during the follow-up period (up to 4 weeks), no deterioration in patients' well-being, recurrence of GAD symptoms, or withdrawal symptoms were observed. The emergence of a new, effective and well-tolerated anxiolytic drug certainly expands the physician’s therapeutic arsenal for the treatment of anxiety disorders.

Keywords

generalized anxiety disorder, medication, drug safety and efficacy, pharmacotherapy, therapy efficacy, drug safety profile, double-blind, placebo-controlled clinical trial

PDF (Русский)

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