Pregabalin for the treatment of generalized anxiety disorder (GAD): Efficacy and safety in elderly patients

Abstract

Objective:

To evaluate the safety and efficacy of pregabalin in relieving the symptoms of GAD in patients ≥65 years of age.

Methods:

This was a multicenter, randomized, flexible-dose, placebo-controlled, double-blind, parallel-group trial of pregabalin in the treatment of GAD. Randomization was 2:1, pregabalin:placebo. Patients underwent an 8-week double-blind, flexible-dosage (150-600 mg/d) treatment phase, including a 1-week dose-escalation period (50 mg/d to 150 mg/d). The primary efficacy assessment was change from baseline to endpoint-LOCF in HAM-A total score. Additionally, change from baseline to week 8 (observed cases) in HAM-A psychic and somatic factors was evaluated.

Results:

Mean age at GAD onset was 56 years; 77% of patients were women; mean age at enrollment was 72 years; mean duration of GAD was 17 years. Mean change from baseline in HAM-A total score was –12.84 (n=177) for the pregabalin group and –10.7 (n=96) for the placebo group (P=.0437). At week 8, patients treated with pregabalin had significant improvement in both the HAM-A psychic (–7.8 vs –6.3, P=.0111) and somatic (–6.6 vs –5.4, P=.0248) factors. The most common adverse events (AEs) among pregabalin-treated patients were dizziness (20.3%), somnolence (13.0%), headache (10.2%), and nausea (9.0%). Most AEs were mild-to-moderate and self-limiting. Discontinuation rates due to AEs were 10.7% and 9.4% in the pregabalin and placebo groups, respectively.

Conclusions:

Pregabalin was effective in reducing the symptoms of GAD in patients aged 65 years and older, and it was safe and well tolerated in this population.