Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder
Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder
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DOI：
10.1097/yic.0b013e3283530ad7
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发表时间：
2012-07-01
影响因子：
2.6
通讯作者：
Florea, Ioana
中科院分区：
文献类型：
--
作者：
Baldwin, David S.;Loft, Henrik;Florea, Ioana
本研究的目的是探讨Lu AA21004 5或10 mg/天预防广泛性焦虑障碍（GAD）患者复发的疗效的长期维持。初步诊断为GAD （DSM-IV标准）且基线汉密尔顿焦虑（HAM-A）总分至少为20分的患者（n = 687）接受了为期20周的开放标签Lu AA21004治疗。总共有459名患者有反应，并被随机分配到24-56周的双盲治疗中，使用Lu AA21004 （n = 229）或安慰剂（n = 230）。采用Cox模型，预先设定的主要疗效终点为复发时间（HAM-A总分>= 15）；在多重性控制下，关键的次要疗效终点是治疗至少12周的患者的复发时间。初步分析显示，与安慰剂相比，Lu AA21004对GAD复发时间的影响具有统计学意义，风险比为2.71 （P < 0.001）。Lu AA21004对稳定应答者的影响有统计学意义（风险比= 3.06,P < 0.001）。Lu AA21004耐受性良好，双盲期不良事件停药率分别为9%（开放标签）、3%（安慰剂）和4% （Lu AA21004）。在本研究中，Lu AA21004 5或10 mg/天均能有效预防复发，并且在GAD维持治疗中耐受性良好。中国精神病学杂志，27(3),2012。
The purpose of this study was to investigate the long-term maintenance of the efficacy of Lu AA21004 5 or 10 mg/day in the prevention of relapse in patients with generalized anxiety disorder (GAD). Patients (n = 687) with a primary diagnosis of GAD (DSM-IV criteria) and a baseline Hamilton Anxiety (HAM-A) total score of at least 20 underwent a 20-week, open-label Lu AA21004 treatment. In all, 459 patients responded and were randomized to 24-56 weeks of a double-blind treatment with Lu AA21004 (n = 229) or placebo (n = 230). The predefined primary efficacy endpoint was time to relapse (HAM-A total score >= 15) using a Cox model; the key secondary efficacy endpoint under multiplicity control was time to relapse for patients responding to treatment for at least 12 weeks. The primary analysis showed a statistically significant effect of Lu AA21004 relative to the placebo on the time to relapse of GAD, with a hazard ratio of 2.71 (P < 0.001). There was a statistically significant effect of Lu AA21004 in the stable responders (hazard ratio = 3.06, P < 0.001). Lu AA21004 was well tolerated, with withdrawal rates due to adverse events of 9% (open-label) and 3% (placebo) and 4% (Lu AA21004) in the double-blind period. In this study, Lu AA21004 5 or 10 mg/day was efficacious in preventing relapse and was well tolerated in the maintenance treatment of GAD. Int Clin Psychopharmacol 27:197-207 (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.