Mexazolam and Alprazolam in the Treatment of Generalised Anxiety Disorder: A Double-Blind, Randomised Clinical Trial
Authors: Vaz-Serra A.1; Figueira M.L.2; Bessa-Peixoto A.3; Firmino H.2; Albuquerque R.2; Paz C.3; Dolgner A.4; Vaz-Silva M.4; Almeida L.4
Source: Clinical Drug Investigation, Volume 21, Number 4, 1 April 2001 , pp. 257-263(7)
Publisher: Adis International
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Abstract:
Objective: To compare the anxiolytic effects of mexazolam with those of alprazolam in patients with generalised anxiety disorder (GAD).Methods: Multicentre, randomised, double-blind, parallel-group clinical trial in 64 outpatients with GAD (DSM-IV criteria). Patients were assigned to mexazolam 1mg three times daily (n = 32) or alprazolam 0.5mg three times daily (n = 32) during 1 week, followed sequentially by a period of 2 weeks of reducing dosage according to therapeutic response and by 1-week taper and 1-week treatment-free periods. The Hamilton Anxiety Rating Scale (HAM-A), the Clinical Global Impression (CGI), and the Snaith & Zigmund anxiety and depression self-rating scale (SZS) were used to evaluate the patient 's clinical status.Results: Both treatment groups showed a statistically significant anxiolytic effect: a decrease of mean HAM-A score of 16.28 with mexazolam (p < 0.0001 vs baseline) and 14.2 with alprazolam (p < 0.0001) and a reduction in CGI-disease severity score of 2.66 (p < 0.0001) with mexazolam and 2.44 with alprazolam (p < 0.0001). Although a higher absolute rate of responders was observed in the mexazolam group, there were no statistically significant differences in the between-group comparisons (80% vs 70% in HAM-A and 96.7% vs 86.7% in CGI evaluations). Five mexazolam and nine alprazolam recipients reported mild adverse events.Conclusion: Both mexazolam and alprazolam showed a significant anxiolytic effect and were well tolerated in the treatment of GAD, making it an effective pharmacotherapeutic alternative in the treatment of GAD.Keywords: Alprazolam, therapeutic use; Anxiety disorders, treatment; Anxiolytics, therapeutic use; Generalised anxiety disorders, treatment; Mexazolam, therapeutic use
Document Type: Original article
Affiliations: 1: Department of Psychiatry, Hospital of the University of Coimbra, Coimbra, Portugal 2: Department of Psychiatry, Hospital Santa Maria/Faculty of Medicine, Lisbon, Portugal 3: Department of Psychiatry, Hospital S. Marcos, Braga, Portugal 4: Department of Research & Development, Bial, S. Mamede do Coronado, Portugal
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