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A non-inferiority comparison of duloxetine and venlafaxine in the treatment of adult patients with generalized anxiety disorder

Department of Clinical Neuroscience, Section of Psychiatry, Karolinska Institutet, Stockholm, Sweden, christer.allgulander{at}ki.se

D Nutt

Psychopharmacology Unit, University of Bristol, Bristol, UK

M Detke

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA, Department of Psychiatry, McLean Hospital/Harvard Medical School, Boston, MA, USA

J Erickson

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, Department of Psychiatry, McLean Hospital/Harvard Medical School, Boston, MA, USA, Orexigen Therapeutics, San Diego, CA, USA

M Spann

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

D Walker

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

SG Ball

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA

JM Russell

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

The present study is a non-inferiority comparison of duloxetine 60— 120 mg/day and venlafaxine extended-release (XR) 75—225 mg/day for the treatment of adults with generalized anxiety disorder (GAD). The non-inferiority test was a prespecified plan to pool data from two nearly identical 10-week, multicentre, randomized, placebo-controlled, double-blind studies of duloxetine 60-120 mg/day and venlafaxine 75—225 mg/ day for the treatment of GAD. An independent expert consensus panel provided six statistical and clinical criteria for determining non-inferiority between treatments. Response was defined as 50% reduction in Hamilton Anxiety Rating Scale (HAMA) total score. In the pooled sample, patients were randomly assigned to duloxetine (n = 320), venlafaxine XR (n = 333) or placebo (n = 331). For the non-inferiority analysis, the per-protocol patients who were treated with duloxetine (n = 239) or venlafaxine XR (n = 262) improved significantly more (mean HAMA reductions were –15.4 and –15.2, respectively) than placebo-treated patients (n = 267; –11.6, P 0.001, both comparisons). Response rates were 56%, 58% and 40%, respectively. Discontinuation rate because of AEs was significantly higher for duloxetine (13.4%, P 0.001) and venlafaxine XR (11.4%, P 0.01) groups compared with placebo (5.4%). Duloxetine 60—120 mg/day met all statistical and clinical criteria for non-inferiority and exhibited a similar tolerability profile compared with venlafaxine XR 75—225 mg/day for the treatment of adults with GAD.

Key Words: duloxetine • generalized anxiety disorder • non-inferiority • treatment • venlafaxine

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