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).

Conclusion: Duloxetine was effective in an elderly patient subset with GAD, although there was a high rate of discontinuations due to adverse events.