Efficacy and tolerability of duloxetine in elderly patients with generalized anxiety disorder: a pooled analysis of four randomized, double-blind, placebo-controlled studies.
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 (>or=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 >or= 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).


CONCLUSIONS
Duloxetine was effective in an elderly patient subset with GAD, although there was a high rate of discontinuations due to adverse events.
Davidson
Jonathan
J
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA. jonathan.davidson@duke.edu
Allgulander
Christer
C
Pollack
Mark H
MH
Hartford
James
J
Erickson
Janelle S
JS
Russell
James M
JM
Perahia
David
D
Wohlreich
Madalaine M
MM
Carlson
Janice
J
Raskin
Joel
J
D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000368:Aged; D001008:Anxiety Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
D018759:Adrenergic Uptake Inhibitors; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes