科研之友
微信
新浪微博
Facebook
分享链接
摘要
Background: Coexisting anxiety is common in major depressive disorder (MDD) and more difficult to treat than depression without anxiety. This analysis assessed the efficacy, safety, and tolerability of vortioxetine in MDD patients with high levels of anxiety (baseline Hamilton Anxiety Rating Scale [HAM A] total score >= 20). Methods: Efficacy was assessed using an aggregated, study-level meta-analysis of 10 randomized, placebo-controlled, 6/8-week trials of vortioxetine 5-20 mg/day in adults (18-75 years), with a study in elderly patients (>= 65 years) analyzed separately. Outcome measures included mean differences from placebo in change from baseline to endpoint (Delta) in the Montgomery-Asberg Depression Rating Scale (MADRS), HAM-A total, and HAM-A subscales. Safety and tolerability were assessed by treatment emergent adverse events (TEAEs). Results: A total of 1497 (48.6%) vortioxetine-treated and 860 (49.1%) placebo-treated patients had baseline HAM-A >= 20. There were significant differences from placebo in MADRS (vortioxetine 5 mg/day, n=415, Delta-2.68, P=0.005; 10 mg/day, n=373, Delta-3.59, P < 0.001; 20 mg/day, n=207, Delta-4.30, P=0.005) and HAM-A total (5 mg/day, n=419, Delta-1.64, P=0.022; 10 mg/day, n=373, Delta-2.04, P=0.003; 20 mg/day, n=207, Delta-2.19, P=0.027). There were significantly greater improvenients versus placebo on the HAM-A psychic subscale for all doses. The most common TEAEs (>= 5.0%) were nausea, headache, dizziness, dry mouth, diarrhea, nasopharyngitis, constipation, and vomiting. Incidence of serious TEAEs was 1.3% (placebo) and <= 1.3% (vortioxetine, across doses). Limitations: Study heterogeneity limits this analysis. Patients with baseline HAM-A >= 20 were not directly compared to baseline HAM-A < 20 or total MDD population. Conclusions: Vortioxetine was efficacious in reducing depressive and anxiety symptoms in patients with MDD and high levels of anxiety.
- 出版日期2016-12
