McMaster University, Hamilton, Ontario, Canada.
Menopause. 2010 Jul;17(4):700-11. doi: 10.1097/gme.0b013e3181d88962.
This study assessed the efficacy, safety, and tolerability of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine and the selective serotonin reuptake inhibitor escitalopram for major depressive disorder (MDD) in postmenopausal women.
In this randomized, double-blind study, postmenopausal outpatients (aged 40-70 y) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition MDD received flexible-dose desvenlafaxine (100-200 mg/d) or escitalopram (10-20 mg/d) for 8 weeks. Acute-phase responders, that is, women with a 50% or greater reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, were eligible to continue the same double-blind treatment in the 6-month continuation phase. The primary efficacy outcomes were mean change from baseline in HAM-D17 total score (acute phase), analyzed using a mixed-effects model for repeated measures, and the proportion of women who maintained response (continuation phase), analyzed using logistic regression.
Reductions in HAM-D17 total score at acute-phase endpoint were similar for desvenlafaxine- and escitalopram-treated women (-13.6 vs -14.3, respectively; P = 0.24). No significant difference was observed between groups at continuation-phase endpoint in the proportion of women who maintained response (desvenlafaxine, 82%; escitalopram, 80%; P = 0.70). In both phases, desvenlafaxine and escitalopram were generally safe and well tolerated.
Among postmenopausal outpatients with MDD, there were no significant differences in the efficacy of desvenlafaxine and escitalopram based on primary efficacy analyses. The results do not support the overall hypothesis that the serotonin-norepinephrine reuptake inhibitor desvenlafaxine has an efficacy advantage for the treatment of MDD in postmenopausal women because, in this particular subgroup, desvenlafaxine failed to prove superiority over escitalopram. Safety and tolerability were comparable.
本研究评估了去甲肾上腺素- 血清素再摄取抑制剂地昔帕明和选择性血清素再摄取抑制剂依地普仑治疗绝经后妇女重性抑郁障碍（MDD）的疗效、安全性和耐受性。
在这项随机、双盲研究中，绝经后门诊患者（年龄 40-70 岁）符合《精神障碍诊断与统计手册》第 4 版 MDD 标准，接受了地昔帕明（100-200mg/d）或依地普仑（10-20mg/d）的灵活剂量治疗，疗程 8 周。急性期应答者，即汉密尔顿抑郁量表 17 项总分（HAM-D17）较基线降低 50%或更多的患者，有资格继续参加 6 个月的双盲维持治疗期。主要疗效终点为 HAM-D17 总分自基线的平均变化（急性期），采用重复测量混合效应模型进行分析；维持治疗期的女性应答者比例采用 logistic 回归进行分析。
地昔帕明和依地普仑治疗的女性在急性期终点时 HAM-D17 总分的降低相似（分别为-13.6 分和-14.3 分；P=0.24）。在维持治疗期终点，两组的女性应答者比例无显著差异（地昔帕明组为 82%，依地普仑组为 80%；P=0.70）。在两个阶段，地昔帕明和依地普仑通常安全且耐受性良好。
在绝经后 MDD 门诊患者中，基于主要疗效分析，地昔帕明和依地普仑的疗效无显著差异。结果不支持去甲肾上腺素- 血清素再摄取抑制剂地昔帕明在治疗绝经后妇女 MDD 方面具有疗效优势的总体假设，因为在这个特定亚组中，地昔帕明未能证明优于依地普仑。安全性和耐受性相当。
