阿塞那平透皮系统HP-3070对成年精神分裂症患者敌意症状的疗效:一项为期6周的3期研究的事后分析

L. Citrome, Marina Komaroff, Brittney R Starling, Sandeep Byreddy, T. Terahara, M. Hasebe
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引用次数: 0

摘要

目的:精神分裂症患者可能表现出敌意症状。HP-3070是美国食品和药物管理局(FDA)批准的第一个用于成人精神分裂症的抗精神病贴片。其疗效已在一项三期研究中得到证实。本事后分析评估了HP-3070治疗精神分裂症敌意的疗效。方法:在2016年8月至2017年11月进行的关键3期研究中,成年精神分裂症患者(按照DSM-5标准)随机分为HP-3070 3.8 mg/24 h、HP-3070 7.6 mg/24 h或安慰剂组。从基线到第6周,使用混合效应模型对阳性和阴性综合征量表(PANSS)敌意项目和PANSS-兴奋成分(PANSS- ec)得分的最小二乘平均值(LSM)变化进行事后评估,该模型用于重复测量,调整了选定的PANSS-阳性症状和嗜睡或无运动障碍的存在。结果:442例基线PANSS敌意项目评分>.1 (n = 151, HP-3070 7.6 mg/24 h;N = 147, 3.8 mg/24 h;n = 144,安慰剂),第6周LSM (95% CI)从基线(CFB)的敌意评分变化HP-3070优于安慰剂7.6 mg/24 h(-0.4[-0.6至-0.2];P 1。结论:在这项事后分析中,HP-3070在减少精神分裂症相关敌意方面优于安慰剂,即使在调整协变量后也是如此,这表明这些作用至少部分独立于一般抗精神病药物作用或镇静或静坐的作用。这些发现表明HP-3070对精神分裂症患者具有特异性的抗敌意作用。临床试验注册:ClinicalTrials.gov标识符:NCT02876900;审稿号:2015-005134-21。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study.
Objective: Patients with schizophrenia may exhibit symptoms of hostility. HP-3070 is the first antipsychotic patch approved by the US Food and Drug Administration (FDA) for adults with schizophrenia. Its efficacy was demonstrated in a phase 3 study. This post hoc analysis assessed the efficacy of HP-3070 in treating hostility in schizophrenia. Methods: In the pivotal phase 3 study, conducted between August 2016 and November 2017, adults with schizophrenia (per DSM-5 criteria) were randomized to HP-3070 3.8 mg/24 h, HP-3070 7.6 mg/24 h, or placebo. Least-squares mean (LSM) changes in Positive and Negative Syndrome Scale (PANSS) hostility item and PANSS-Excited Component (PANSS-EC) scores from baseline to week 6 were assessed post hoc using a mixed-effects model for repeated measures adjusted for selected PANSS-Positive symptoms and presence of somnolence or akathisia. Results: Among 442 patients with baseline PANSS hostility item score > 1 (n = 151, HP-3070 7.6 mg/24 h; n = 147, 3.8 mg/24 h; n = 144, placebo), week 6 LSM (95% CI) change from baseline (CFB) in hostility score was superior with HP-3070 versus placebo for 7.6 mg/24 h (-0.4 [-0.6 to -0.2]; P < .001) and 3.8 mg/24 h (-0.3 [-0.6 to -0.1]; P < .01), with similar results for 7.6 mg/24 h after adjusting for covariates (P < .05). For all patients regardless of baseline PANSS hostility item score, PANSS-EC week 6 LSM CFB was greater for HP-3070 7.6 mg/24 h (-1.1 [-1.9 to -0.4]; n = 203; P < .01) and 3.8 mg/24 h (-1.3 [-2.0 to -0.6]; n = 201; P < .001) than for placebo (n = 203), with similar results observed in patients with baseline hostility item score > 1. Conclusions: In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia. These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT02876900; EudraCT number: 2015-005134-21.
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