当前位置： SCI文献检索 > CURRENT MEDICAL RESEARCH AND OPINION期刊下所有文献 > Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability.

Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability.

Abstract：

OBJECTIVE:Short-term clinical trials have demonstrated the efficacy and safety of pregabalin in the treatment of generalized anxiety disorder (GAD). This study examined long-term safety and tolerability of pregabalin in patients with GAD, social anxiety disorder (SAD), or panic disorder (PD). RESEARCH DESIGN AND METHODS:Patients (n = 528) completing one of four randomized, double-blind, placebo-controlled trials of pregabalin for GAD, SAD, or PD were treated, open label, with flexible-dose pregabalin (150-600 mg/day) for 1 year. CLINICAL TRIAL REGISTRATION:NCT00150449. MAIN OUTCOME MEASURES:The primary outcomes were safety and tolerability. Illness severity was assessed at baseline and Weeks 27/52 using the Clinical Global Impression of Severity (CGI-S) scale. Patients were characterized as 'responders' or 'non-responders' based on CGI-S scores ≤2 and >2, respectively. Analyses were performed on the total anxiety (GAD, SAD and PD) and GAD groups. RESULTS:During 1 year of treatment with pregabalin, dizziness (12.5%) was the only treatment-related adverse event (AE) occurring ≥10%. Somnolence, weight gain, headache and insomnia occurred at 7.6%, 5.5%, 5.3% and 4.7%, respectively. Few treatment-related AEs were rated as severe in the total anxiety (5.1%) or GAD (3.6%) groups. Discontinuation rates due to AEs were similar (9.7% and 10.6%, respectively). No clinically significant laboratory, electrocardiogram, or other treatment-related safety findings were noted, except for treatment-related weight gain, which occurred in both the total (24.4%) and GAD (19.4%) groups. Mean CGI-S scores were similar at baseline in the total (n = 528; score, 3.4) and GAD groups (n = 330; score, 3.6), and CGI-S responder rates were similar at last-observation-carried-forward endpoint (51.3% and 48.1%, respectively). CONCLUSIONS:Pregabalin was generally well tolerated in the long-term treatment of anxiety disorders. Improvement in illness severity was maintained over time. The key limitations of this study were that it was not randomized and neither placebo- nor active-comparator-controlled.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Montgomery S,Emir B,Haswell H,Prieto R

doi

10.1185/03007995.2013.820694

subject

Has Abstract

pub_date

2013-10-01 00:00:00

pages

1223-30

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

临床试验,杂志文章,多中心研究

在线工具

Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability.