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Efficacy and tolerability of duloxetine in elderly patients with generalized anxiety disorder: a pooled analysis of four randomized, double‐blind, placebo‐controlled studies
Author(s) -
Davidson Jonathan,
Allgulander Christer,
Pollack Mark H.,
Hartford James,
Erickson Janelle S.,
Russell James M.,
Perahia David,
Wohlreich Madalaine M.,
Carlson Janice,
Raskin Joel
Publication year - 2008
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.949
Subject(s) - duloxetine , tolerability , placebo , medicine , anxiety , psychology , nausea , adverse effect , somatic anxiety , generalized anxiety disorder , randomized controlled trial , anesthesia , psychiatry , pathology , alternative medicine
Objective To assess the efficacy and tolerability of duloxetine in elderly patients with generalized anxiety disorder (GAD). Methods Acute‐phase data from a subset of patients (≥65 years) with GAD were pooled from four randomized, double‐blind, placebo‐controlled trials of duloxetine (3 flexible, 1 fixed dosing). Patients were treated with duloxetine 60–120 mg once daily or placebo for 9–10 weeks. The primary outcome measure was the mean baseline‐to‐endpoint change in Hamilton anxiety scale (HAMA) total score. Secondary measures included the HAMA psychic and somatic anxiety subscales and the Hospital Anxiety Depression Scale (HADS). Results Of 1491 patients randomly assigned to treatment, 4.9% (duloxetine, n = 45; placebo, n = 28) were ≥ 65 years old. Compared with placebo‐treated patients, duloxetine‐treated patients experienced significantly greater improvements on the HAMA‐total ( p = 0.029), the HAMA‐psychic anxiety factor ( p = 0.034), HADS‐anxiety ( p = 0.049) and ‐depression scales ( p = 0.026), but not the HAMA somatic anxiety factor ( p = 0.074). Nausea was reported significantly more often in duloxetine‐treated patients (30.0% vs. 7.1%, p = 0.023); duloxetine‐treated patients experienced greater weight loss ( p = 0.018). More duloxetine‐treated patients discontinued treatment due to an adverse event (22.2% vs. 0%; p = 0.006). Conclusion Duloxetine was effective in an elderly patient subset with GAD, although there was a high rate of discontinuations due to adverse events. Copyright © 2008 John Wiley & Sons, Ltd.