Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. (October 2013)

• Record Type: Journal Article
• Authors: Montgomery, Stuart; Emir, Birol; Haswell, Hannah; Prieto, Rita
• Is Part Of: Current medical research and opinion. Volume 29:Number 10(2013:Oct.)
• Page Start: 1223
• Page End: 1230
• Publication Date: 2013-10
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2013.820694
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>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).</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>Patients (<italic>n</italic> = 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.</p> </sec> <sec id="ss3"> <title>Clinical trial registration:</title> <p>NCT00150449.</p> </sec> <sec id="ss4"> <title>Main outcome measures:</title> <p>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.</p> </sec> <sec id="ss5"> <title>Results:</title> <p>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 (<italic>n</italic> = 528; score, 3.4) and GAD groups (<italic>n</italic> = 330; score, 3.6), and CGI-S responder rates were similar at last-observation-carried-forward endpoint (51.3% and 48.1%, respectively).</p> </sec> <sec id="ss6"> <title>Conclusions:</title> <p>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.</p> </sec> </abstract>