Global Medical Affairs, Pfizer Ltd., Tadworth, UK.
Global Medical Affairs, Pfizer GEP SLU, Madrid, Spain.
Int Clin Psychopharmacol. 2019 May;34(3):110-118. doi: 10.1097/YIC.0000000000000256.
Effects of baseline anxiety on the efficacy of venlafaxine extended release versus placebo were examined in a post hoc pooled subgroup analysis of 1573 patients enrolled in eight short-term studies of major depressive disorder. Anxiety subgroups were defined based on baseline 17-item Hamilton Rating Scale for Depression Item 10 score <3 (low) versus ≥3 (high). Change from baseline to final visit in Montgomery-Åsberg Depression Rating Scale total score and Montgomery-Åsberg Depression Rating Scale response and remission rates were analyzed. Change from baseline in Montgomery-Åsberg Depression Rating Scale total score and response and remission rates was significantly greater for venlafaxine extended release versus placebo in both low and high anxiety subgroups (all P < 0.0001). A statistically significant baseline anxiety by treatment interaction was observed for Montgomery-Åsberg Depression Rating Scale total score only (P = 0.0152). The adjusted mean change from baseline in Montgomery-Åsberg Depression Rating Scale total score was significantly greater in the high anxiety subgroup versus low anxiety subgroup for patients treated with venlafaxine extended release (-6.27 versus -3.89; P = 0.0440) but not placebo. These results support the efficacy of venlafaxine extended release for major depressive disorder treatment in patients with anxiety symptoms.
在 8 项短程重性抑郁障碍研究的 1573 例患者中，进行了事后亚组分析，评估了基线焦虑对文拉法辛缓释制剂与安慰剂疗效的影响。根据基线汉密尔顿抑郁量表 17 项总分第 10 项得分<3（低）与≥3（高），将焦虑亚组定义。分析了从基线到最终访视时蒙哥马利-Åsberg 抑郁评定量表总分和蒙哥马利-Åsberg 抑郁评定量表反应和缓解率的变化。文拉法辛缓释制剂与安慰剂相比，在低焦虑和高焦虑亚组中，从基线到最终访视时蒙哥马利-Åsberg 抑郁评定量表总分以及反应和缓解率的变化显著更大（均 P<0.0001）。仅观察到蒙哥马利-Åsberg 抑郁评定量表总分的基线焦虑与治疗的交互作用具有统计学意义（P=0.0152）。与低焦虑亚组相比，接受文拉法辛缓释制剂治疗的患者中，高焦虑亚组从基线到蒙哥马利-Åsberg 抑郁评定量表总分的调整平均变化显著更大（-6.27 与-3.89；P=0.0440），但安慰剂组无此差异。这些结果支持文拉法辛缓释制剂对伴有焦虑症状的重性抑郁障碍患者的疗效。
