Abstract 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.
OTSUBO et al. (Mon,) studied this question.