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

Author(s): Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B

Affiliation(s): Department of General Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.

Publication date & source: 2009-03, Int Clin Psychopharmacol., 24(2):87-96.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

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