title: 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: Department of General Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.
authors: Siegfried
authors: S
authors: Kasper
authors: Barry
authors: B
authors: Herman
authors: Giancarlo
authors: G
authors: Nivoli
authors: Michael
authors: M
authors: Van Ameringen
authors: Antonino
authors: A
authors: Petralia
authors: Francine S
authors: FS
authors: Mandel
authors: Francesca
authors: F
authors: Baldinetti
authors: Borwin
authors: B
authors: Bandelow
mesh_terms: D000328:Adult; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000503:physiopathology; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D018691:Excitatory Amino Acid Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014179:Neurotransmitter Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D009638:Norepinephrine / Q000502:physiology; D010352:Patient Dropouts; D000069583:Pregabalin; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D000069470:Venlafaxine Hydrochloride; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D014151:Anti-Anxiety Agents; D003511:Cyclohexanols; D018691:Excitatory Amino Acid Antagonists; D014179:Neurotransmitter Uptake Inhibitors; D009638:Norepinephrine; D000069583:Pregabalin; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride; D005680:gamma-Aminobutyric Acid