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首页> 美国卫生研究院文献>Lippincott Williams Wilkins Open Access >Efficacy and safety of vortioxetine (Lu AA21004) 15 and 20 mg/day: a randomized double-blind placebo-controlled duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder
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Efficacy and safety of vortioxetine (Lu AA21004) 15 and 20 mg/day: a randomized double-blind placebo-controlled duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder

机译：伏替西汀（Lu AA21004）的疗效和安全性（每天15毫克和20毫克）：一项随机双盲安慰剂对照度洛西汀为参考的研究用于成人重大抑郁症患者的急性治疗

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This study assessed the efficacy, tolerability and safety of vortioxetine versus placebo in adults with recurrent major depressive disorder. This double-blind, randomized, placebo-controlled study included 608 patients [Montgomery–Åsberg Depression Rating Scale (MADRS) total score≥26 and Clinical Global Impression – Severity score≥4]. Patients were randomly assigned (1 : 1 : 1 : 1) to vortioxetine 15 mg/day, vortioxetine 20 mg/day, duloxetine 60 mg/day or placebo. The primary efficacy endpoint was change from baseline in MADRS total score at week 8 (mixed model for repeated measurements). Key secondary endpoints were: MADRS responders; Clinical Global Impression – Improvement scale score; MADRS total score in patients with baseline Hamilton Anxiety Rating Scale ≥20; remission (MADRS≤10); and Sheehan Disability Scale total score at week 8. On the primary efficacy endpoint, both vortioxetine doses were statistically significantly superior to placebo, with a mean difference to placebo (n=158) of −5.5 (vortioxetine 15 mg, P<0.0001, n=149) and −7.1 MADRS points (vortioxetine 20 mg, P<0.0001, n=151). Duloxetine (n=146) separated from placebo, thus validating the study. In all key secondary analyses, both vortioxetine doses were statistically significantly superior to placebo. Vortioxetine treatment was well tolerated; common adverse events (incidence≥5%) were nausea, headache, diarrhea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters. Vortioxetine was efficacious and well tolerated in the treatment of patients with major depressive disorder.
机译：这项研究评估了伏替西汀与安慰剂在复发性重度抑郁症成人中的疗效，耐受性和安全性。这项双盲，随机，安慰剂对照研究包括608例患者[蒙哥马利-奥斯伯格抑郁量表（MADRS）总分≥26，临床总体印象-严重度分≥4]。患者被随机分配（1：1：1：1）伏替西汀15毫克/天，伏替西汀20毫克/天，度洛西汀60毫克/天或安慰剂。主要功效终点是第8周时MADRS总评分的基线变化（重复测量的混合模型）。主要的次要终点是：MADRS响应者；临床总体印象–改善量表分数；基线汉密尔顿焦虑量表≥20的患者的MADRS总分；缓解（MADRS≤10）;和Sheehan Disability Scale总评分在第8周。在主要疗效终点，两种伏替西汀剂量在统计学上均显着优于安慰剂，与安慰剂的平均差异（n = 158）为-5.5（伏替西汀15 mg，P <0.0001，n = 149）和-7.1 MADRS点（伏替西汀20 mg，P <0.0001，n = 151）。度洛西汀（n = 146）从安慰剂中分离出来，从而验证了该研究。在所有关键的次要分析中，两种伏立西汀剂量在统计学上均显着优于安慰剂。伏替西汀治疗耐受性良好；常见不良事件（发生率≥5％）为恶心，头痛，腹泻，口干和头晕。临床安全实验室值，体重，ECG或生命体征参数未见临床相关变化。伏替西汀在重度抑郁症患者的治疗中有效且耐受良好。

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