The Effectiveness of 6-Month Treatment with Venlafaxine Extended Release in Generalized Anxiety Disorder: Prospective, Multi-Center, Open-Labeled Trial / 대한정신약물학회지

ABSTRACT

OBJECTIVE: We aimed to examine the efficacy and the safety of venlafaxine extended release (venlafaxine-XR), and its effect on the quality of life in patients with generalized anxiety disorder. METHODS: Fifty three patients who had generalized anxiety disorder were recruited for this study. They showed scores of 18 or higher on the Hamilton Rating Scale for Anxiety (HAMA) and did not have major depression. They were scheduled to be examined 5 times (at baseline, 4, 8, 16 and 24 weeks) and took venlafaxine-XR for 24 weeks with a flexible dosing schedule. The primary efficacy variables were the response and remission rates (response: more than 50% reduction from baseline in HAMA total score ; remission: HAMA total score< or =7). Other variables were the Hamilton Ratng Scale for Depression, Beck Anxiety Inventory, Sheehan Disabilities Scale (SDS), and World Health Organization Quality of Life Assessment Instrument-Brief Form (WHOQOL-BREF). Also, the evaluation on adverse effects was performed. RESULTS: The number of patients who completed 24 weeks of treatment was 32 (60.4%). Twenty one patients who were dropped out included 8 patients with intolerable adverse effects and 7 patients with unsatisfactory treatment response. Response/remission rates were 43.4/32.1% in the last-observation-carried-forward methods and 71.9/53.1% in the observed case data. Treatment with venlafaxine-XR improved anxiety and depressive symptoms during 24 weeks on all efficacy measures. By a completed patient analysis, venlafaxine-XR also significantly improved the disability scores on SDS and the quality of life scores on WHOQOL-BREF. In this study, nausea, palpitation, and severe tremor were common reasons of venlafaxine-XR discontinuation in GAD patients, but any serious adverse effect did not occur. CONCLUSION: Treatment with venlafaxine-XR was effective and well-tolerated for the patients with GAD, and also improved quality of life in the GAD patients.