Liebowitz Michael R, Asnis Gregory, Mangano Richard, Tzanis Evan
Department of Psychiatry, Columbia University, New York, NY 10025, USA.
J Clin Psychiatry. 2009 Apr;70(4):550-61. doi: 10.4088/jcp.08m04238. Epub 2009 Apr 7.
To evaluate the efficacy, safety, and tolerability of venlafaxine extended release (ER) in short-term treatment of panic disorder.
In this multicenter, double-blind study, conducted from April 2001 to December 2002, 343 adult outpatients who met criteria for panic disorder (with and without agoraphobia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, were randomly assigned to flexible-dose venlafaxine ER (75-225 mg/d) or placebo for 10 weeks (N = 155 per group, intent-to-treat population). The primary outcome measure was the percentage of panic-free patients as assessed using the Sheehan Panic and Anticipatory Anxiety Scale. Key secondary measures included the Panic Disorder Severity Scale (PDSS) score and Clinical Global Impressions-Improvement (CGI-I) scale response (score = 1 or 2). Last-observation-carried-forward data were analyzed, and statistical significance was set at p <or= .05.
At week 10, the percentage of patients who were free from full-symptom panic attacks was 52% in the venlafaxine ER group and 43% in the placebo group (p = .11). Mean change from baseline in PDSS total score was significantly (p = .006) greater for the venlafaxine ER group (-9.3) than for the placebo group (-7.5), and significantly (p = .03) more venlafaxine ER-treated patients achieved CGI-I response (71%) than did those receiving placebo (59%) at week 10. Treatment with venlafaxine ER was generally safe and well tolerated. Adverse events were the primary or secondary cause for discontinuation for 7 placebo patients (4%) and 12 venlafaxine ER patients (7%).
Venlafaxine ER appears to be effective, safe, and well tolerated in short-term treatment of panic disorder, although the results fell just short of significance on the primary outcome measure.
clinicaltrials.gov Identifier: NCT00038896.
评估文拉法辛缓释剂（ER）短期治疗惊恐障碍的疗效、安全性和耐受性。
在这项于2001年4月至2002年12月进行的多中心、双盲研究中，343名符合《精神障碍诊断与统计手册》第四版中惊恐障碍（伴或不伴广场恐惧症）标准的成年门诊患者被随机分配至灵活剂量的文拉法辛ER组（75 - 225毫克/天）或安慰剂组，为期10周（每组N = 155，意向性治疗人群）。主要结局指标是使用Sheehan惊恐和预期焦虑量表评估的无惊恐发作患者的百分比。关键次要指标包括惊恐障碍严重程度量表（PDSS）评分和临床总体印象改善（CGI - I）量表反应（评分 = 1或2）。采用末次观察结转数据进行分析，设定统计学显著性为p≤0.05。
在第10周时，文拉法辛ER组完全无惊恐发作症状的患者百分比为52%，安慰剂组为43%（p = 0.11）。文拉法辛ER组的PDSS总分较基线的平均变化（-9.3）显著大于安慰剂组（-7.5）（p = 0.006），且在第10周时，接受文拉法辛ER治疗的患者达到CGI - I反应（71%）的比例显著高于接受安慰剂治疗的患者（59%）（p = 0.03）。文拉法辛ER治疗总体安全且耐受性良好。不良事件是7名安慰剂组患者（4%）和12名文拉法辛ER组患者（7%）停药的主要或次要原因。
文拉法辛ER在惊恐障碍的短期治疗中似乎有效、安全且耐受性良好，尽管在主要结局指标上结果未达显著性水平。
clinicaltrials.gov标识符：NCT00038896。
