An open-label, long-term extension, multicenter study to evaluate the safety and efficacy of venlafaxine extended release in Japanese outpatients with generalized anxiety disorder.

Aim: This study evaluated the long-term safety and efficacy of venlafaxine extended release (ER), which has been administered for 52 weeks in Japanese adult outpatients with generalized anxiety disorder (GAD). Methods: In this open-label, long-term extension, multicenter study, 135 Japanese patients with GAD were enrolled after completing 10 weeks of treatment with venlafaxine ER or placebo (including tapering) during the preceding placebo-controlled, double-blind study. Venlafaxine ER 75-225 mg/day was to be administered to all participants for 52 weeks in this study. Primary endpoints were the incidence of adverse events and suicidal ideation/behavior. Secondary endpoints included scores of the Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impressions-Severity of Illness (CGI-S), and Clinical Global Impressions-Global Improvement (CGI-I). Results: Venlafaxine ER was overall well-tolerated. Reported adverse events were in line with those reported in the preceding placebo-controlled, double-blind study. No serious adverse events or deaths were reported, and no tendency of venlafaxine ER to induce suicidal ideation was observed. No new safety findings were identified. A constant and consistent decrease in mean HAM-A total scores was observed (baseline: 15.9; Week 52: 8.0), as evidenced by a more pronounced change from baseline. Similar improvements were also observed in CGI-S and CGI-I scores, suggesting the effectiveness of venlafaxine ER with long-term use. Conclusion: The overall safety profile with long-term use of venlafaxine ER was consistent with the one previously observed, confirming the safety of long-term use of venlafaxine ER in Japanese adult patients with GAD.