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首页> 外文期刊>International clinical psychopharmacology >Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study
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Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study

机译：伏替西汀（15和20 mg）在重度抑郁症患者中的安全性和耐受性：开放标签，灵活剂量，52周扩展研究的结果

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Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in patients who completed one of three randomized, double-blind, placebo-controlled, 8-week vortioxetine trials. All patients were switched to 10mg/day vortioxetine for week 1, then adjusted between 15 and 20mg for the remainder of the study, but not downtitrated below 15mg. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), vital signs, laboratory values, physical examination, and the Columbia-Suicide Severity Rating Scale. Efficacy measures included the Montgomery-angstrom sberg Depression Rating Scale, the Hamilton Anxiety Scale, the Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability Scale. Of the 1075 patients enrolled, 1073 received at least one dose of vortioxetine and 538 (50.0%) completed the study. A total of 537 patients withdrew early, with 115 (10.7% of the original study population) withdrawing because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the most common TEAEs (10%) were nausea and headache. Laboratory values, vital signs, and physical examinations revealed no trends of clinical concern. The mean Montgomery-angstrom sberg Depression Rating Scale total score was 19.9 at the start of the extension study and 9.0 after 52 weeks of treatment (observed cases). Similar improvements were observed with the Hamilton Anxiety Scale (-4.2), the Clinical Global Impression Scale-Severity of Illness (-1.2), and the Sheehan Disability Scale (-4.7) total scores after 52 weeks of treatment (observed case). In this 52-week, flexible-dose OLE study, 15 and 20mg vortioxetine were safe and well tolerated. After entry into this study, patients continued to show improvement in depression and anxiety symptoms, as well as overall functioning, throughout the treatment period.
机译：伏替西汀被批准用于治疗患有严重抑郁症的成人。这项开放标签扩展（OLE）研究评估了vortioxetine在重大抑郁症患者的长期治疗中的安全性和耐受性，并通过抑郁，焦虑和整体功能的评估来评估其有效性。这是一项为期52周的灵活剂量OLE研究，研究对象是完成三个随机，双盲，安慰剂对照，为期8周的vortioxetine试验之一的患者。在第1周，所有患者均改用vortioxetine 10mg /天，然后在其余研究中调整为15mg至20mg，但不要调降到15mg以下。安全性和耐受性是根据治疗紧急不良事件（TEAE），生命体征，实验室值，体格检查和哥伦比亚－自杀严重性等级量表评估的。疗效测量包括蒙哥马利-埃斯特伯格抑郁量表，汉密尔顿焦虑量表，临床总体印象量表-疾病严重度和希恩残疾量表。在1075名患者中，有1073名接受了至少一剂伏替西汀治疗，其中538名（50.0％）完成了研究。共有537位患者提前退出，其中115位（占原始研究人群的10.7％）因TEAE退出研究。伏替西汀的长期治疗耐受性良好。最常见的TEAE（10％）是恶心和头痛。实验室值，生命体征和体格检查无临床趋势。扩展研究开始时，平均蒙哥马利-埃斯特伯格抑郁评定量表总分是19.9，治疗52周后是9.0（观察到的病例）。治疗52周后，汉密尔顿焦虑量表（-4.2），临床总体印象量表-疾病严重程度（-1.2）和希恩残疾量表（-4.7）的总得分（观察到的情况）观察到类似的改善。在这项为期52周的灵活剂量OLE研究中，伏替西汀15毫克和20毫克是安全且耐受性良好的。进入本研究后，患者在整个治疗期间继续表现出抑郁和焦虑症状以及整体功能的改善。

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