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

Kasper, Siegfried and Herman, Barry and Nivoli, Giancarlo and Ameringen, Michael Van and Petralia, Antonino and Mandel, Francine S. and Baldinetti, Francesca and Bandelow, Borwin (2009) Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. International Clinical Psychopharmacology, Vol. 24 (2), p. 87-96. ISSN 0268-1315. Article.

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DOI: 10.1097/YIC.0b013e32831d7980

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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.

Item Type:Article
ID Code:6430
Status:Published
Refereed:Yes
Uncontrolled Keywords:Generalized anxiety disorder, pregabalin, venlafaxine-XR
Subjects:Area 06 - Scienze mediche > MED/25 Psichiatria
Divisions:001 Università di Sassari > 01 Dipartimenti > Neuroscienze, scienze materno infantili
Publisher:Lippincott Williams & Wilkins
ISSN:0268-1315
Copyright Holders:© 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins
Deposited On:31 Aug 2011 09:27

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