Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial.

Abstract

The objective of this study was to evaluate the anxiolytic efficacy, and speed of onset of efficacy, of pregabalin (PGB) and venlafaxine-XR (VXR) in patients with generalized anxiety disorder (GAD). In this double-blind trial, outpatients, ages 18-65 years, who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for GAD were randomized to 8 weeks of flexible-dose treatment with PGB (300-600 mg/day), VXR (75-225 mg/day), or placebo (PBO). The intent-to-treat sample consisted of 121 patients on PGB [least square (LS) mean ± SE baseline Hamilton Anxiety Rating Scale (HAM-A), 27.6 ± 0.4], 125 patients on VXR (baseline HAM-A, 27.4 ± 0.4), and 128 patients on PBO (baseline HAM-A, 26.8 ± 0.4). Treatment with PGB was associated with a significantly greater LS mean change in the HAM-A total score at last observation carried forward endpoint versus PBO (-14.5 ± 0.9 vs. -11.7 ± 0.9; P = 0.028). Treatment with VXR was not significant versus PBO at endpoint (-12.0 ± 0.9; -11.7 ± 0.9; P =0.968). Treatment with PGB showed an early onset of improvement, with significantly greater LS mean change in the HAM-A by day 4 versus both PBO (-5.3 ± 0.5 vs. -3.4± 0.5; P = 0.008) and VXR (-2.9 ± 0.5; P = 0.0012). The proportion of patients reporting a severe adverse event was similar for PGB (9.1%) and PBO (7.8%), but higher for VXR (20.0%; P < 0.05). In conclusion, PGB was a safe and effective treatment of GAD, with a significantly earlier onset of anxiolytic activity than VXR.

• Authors: Siegfried Kasper, Barry Herman, Giancarlo Nivoli, Michael Van Ameringen, Antonino Petralia, Francine S Mandel, Francesca Baldinetti, Borwin Bandelow
• Journal: International clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 24 Issue 2 Pg. 87-96 (Mar 2009) ISSN: 1473-5857 [Electronic] England
• PMID: 21456104 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Anxiety Agents
• Cyclohexanols
• Excitatory Amino Acid Antagonists
• Neurotransmitter Uptake Inhibitors
• Serotonin Uptake Inhibitors
• Pregabalin
• gamma-Aminobutyric Acid
• Venlafaxine Hydrochloride
• Norepinephrine

Topics

• Adult
• Anti-Anxiety Agents (adverse effects, therapeutic use)
• Anxiety Disorders (drug therapy, physiopathology)
• Cyclohexanols (adverse effects, therapeutic use)
• Diagnostic and Statistical Manual of Mental Disorders
• Double-Blind Method
• Excitatory Amino Acid Antagonists (adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Neurotransmitter Uptake Inhibitors (adverse effects, therapeutic use)
• Norepinephrine (physiology)
• Patient Dropouts
• Pregabalin
• Psychiatric Status Rating Scales
• Quality of Life
• Selective Serotonin Reuptake Inhibitors (adverse effects, therapeutic use)
• Time Factors
• Venlafaxine Hydrochloride
• gamma-Aminobutyric Acid (adverse effects, analogs & derivatives, therapeutic use)