Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada.
J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.
Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. We report the results of long-term treatment with asenapine in patients with bipolar I disorder.
Patients completing either of two 3-week efficacy trials and a subsequent 9-week double-blind extension were eligible for this 40-week double-blind extension. Patients in the 3-week trials were randomized to flexible-dose asenapine (5 or 10mg BID), placebo, or olanzapine (5-20mg QD; included for assay sensitivity only). Patients entering the extension phase maintained their preestablished treatment; those originally randomized to placebo received flexible-dose asenapine (placebo/asenapine). Safety and tolerability endpoints included adverse events (AEs), extrapyramidal symptoms, laboratory values, and anthropometric measures. Efficacy, a secondary assessment, was measured as change in Young Mania Rating Scale (YMRS) total score from 3-week trial baseline to week 52 with asenapine or olanzapine; the placebo/asenapine group was assessed for safety only.
Incidence of treatment-emergent AEs was 71.9%, 86.1%, and 79.4% with placebo/asenapine, asenapine, and olanzapine, respectively. The most frequent treatment-emergent AEs were headache and somnolence with placebo/asenapine; insomnia, sedation, and depression with asenapine; and weight gain, somnolence, and sedation with olanzapine. Among observed cases, mean ± SD changes in YMRS total score at week 52 were -28.6 ± 8.1 and -28.2 ± 6.8 for asenapine and olanzapine, respectively.
The study did not have a long-term placebo group.
In this 52-week extension in patients with bipolar mania, asenapine was well tolerated and long-term maintenance of efficacy was supported.
阿塞那平在美国被批准用于治疗伴有或不伴有精神病特征的双相 I 型障碍的急性躁狂或混合发作。我们报告了阿塞那平治疗双相 I 型障碍患者的长期治疗结果。
完成两项为期 3 周疗效试验并随后进入 9 周双盲扩展期的患者有资格参加这项为期 40 周的双盲扩展期。在 3 周试验中，患者被随机分配到阿塞那平（5 或 10mg BID）、安慰剂或奥氮平（5-20mg QD；仅用于检测灵敏度）的灵活剂量组。进入扩展阶段的患者维持其预先确定的治疗方案；最初随机分配到安慰剂的患者接受灵活剂量的阿塞那平（安慰剂/阿塞那平）。安全性和耐受性终点包括不良事件（AE）、锥体外系症状、实验室值和人体测量指标。疗效是次要评估指标，用 3 周试验基线至 52 周时的 Young Mania Rating Scale（YMRS）总分变化来衡量，使用阿塞那平和奥氮平；仅评估安慰剂/阿塞那平组的安全性。
安慰剂/阿塞那平、阿塞那平和奥氮平的治疗中出现的不良事件发生率分别为 71.9%、86.1%和 79.4%。最常见的治疗中出现的不良事件是头痛和安慰剂/阿塞那平引起的嗜睡；阿塞那平引起的失眠、镇静和抑郁；奥氮平引起的体重增加、嗜睡和镇静。在观察病例中，阿塞那平和奥氮平治疗 52 周时 YMRS 总分的平均变化分别为-28.6 ± 8.1 和-28.2 ± 6.8。
该研究没有长期安慰剂组。
在这项为期 52 周的双相躁狂症患者扩展研究中，阿塞那平耐受性良好，疗效长期维持。
