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Guideline A non-inferiority comparison of duloxetine and venlafaxine in the treatment of adult patients with generalized anxiety disorder. 2008
Allgulander C, Nutt D, Detke M, Erickson J, Spann M, Walker D, Ball SG, Russell JM. · Department of Clinical Neuroscience, Section of Psychiatry, Karolinska Institutet, Stockholm, Sweden. · J Psychopharmacol. · Pubmed #18635722 No free full text.
Abstract: 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 > or =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 < or = 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 < or = 0.001) and venlafaxine XR (11.4%, P < or = 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.
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Article Quality of life among patients with a brain tumor and their carers. 2007
Janda M, Steginga S, Langbecker D, Dunn J, Walker D, Eakin E. · School of Public Health and Institute of Health and Biomedical Innovation, Queensland University of Technology, Department of Neurosurgery, Royal Women's and Brisbane Hospital, Brisbane, Queensland, Australia. · J Psychosom Res. · Pubmed #18061752 No free full text.
Abstract: OBJECTIVE: This study assessed the quality of life and psychosocial well-being of brain tumor patients and their carers. METHODS: A cross-sectional postal survey was completed by 75 patients and 70 carers (response rate=29.8%) who were listed in a community-based brain tumor support group database. Measures used were the Functional Assessment of Cancer Therapy-General (FACT-G) and the Hospital Anxiety and Depression Scale (HADS). Queensland population-based norms for the FACT-G were used for comparison. RESULTS: On average, as compared with population norms, the FACT-G summary scores of the patients (mean=74.6, S.D.=18.6) and carers (mean=76.7, S.D.=17.7) were between 0.5 and 1 S.D. lower, representing a clinically significant reduction in their quality of life. Among patients and carers, 30% and 40%, respectively, reported anxious moods and 17% and 10%, respectively, reported depressed moods on the HADS. Significant correlations were observed between the FACT-G and HADS subscales, particularly emotional well-being and anxiety, as well as physical and functional well-being and depression, and between patients' and their carers' quality of life. Among the patients, predictors of lower quality of life were older age and female sex, whereas for the carers, there was a trend for lower quality of life among those looking after a patient with a high-grade disease. CONCLUSIONS: The degree of detriment to quality of life by a brain tumor for patients and that for their carers are similar and clinically significant. The association between the FACT-G subscales and the HADS indicates that improvements could be achieved by alleviating emotional distress and improving functional well-being.
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Article Duloxetine as an SNRI treatment for generalized anxiety disorder: results from a placebo and active-controlled trial. 2007
Hartford J, Kornstein S, Liebowitz M, Pigott T, Russell J, Detke M, Walker D, Ball S, Dunayevich E, Dinkel J, Erickson J. · Community Research, Cincinnati, Ohio 45227, USA. · Int Clin Psychopharmacol. · Pubmed #17414743 No free full text.
Abstract: This study examined the efficacy and tolerability of duloxetine 60-120 mg/day for the treatment of patients with generalized anxiety disorder. This was a multicenter, randomized, double-blind, flexible-dose, placebo and active-controlled (venlafaxine extended-release 75-225 mg/day) trial designed to assess duloxetine 60-120 mg/day during 10 weeks of treatment in adults with Diagnostic and statistical manual of mental disorders-IV-defined generalized anxiety disorder. The primary efficacy outcome measure was mean change from baseline to endpoint in the Hamilton Anxiety Rating Scale total score assessed using analysis of covariance. A total of 487 patients were randomly assigned to duloxetine (n=162), venlafaxine XR (n=164), or placebo (n=161). Significantly greater improvement on the Hamilton Anxiety Rating Scale total score occurred in the duloxetine (P=0.007) and venlafaxine XR (P<0.001) groups compared with the placebo group. Overall discontinuation rates did not differ among the three groups, but adverse event-related discontinuation was significantly higher in the duloxetine (14.2%, P<0.001) and venlafaxine XR (11.0%, P=0.001) groups than in the placebo group (1.9%). During the 2-week drug-tapering phase, discontinuation-emergent adverse events were significantly greater in the venlafaxine XR group (26.9%, P=0.04), but not in the duloxetine group (19.4%, P=0.448) compared with placebo (15.8%). Duloxetine 60-120 mg/day and venlafaxine XR 75-225 mg/day were each efficacious treatments for patients with generalized anxiety disorder.
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