Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer's disease psychosis: A post hoc analysis
Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer's disease psychosis: A post hoc analysis
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DOI：
10.1002/gps.5381
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发表时间：
2020-08-25
影响因子：
4
通讯作者：
Foff, Erin
中科院分区：
文献类型：
--
作者：
Ballard, Clive G.;Coate, Bruce;Foff, Erin
目的阿尔茨海默病精神病（ADP）患者常伴有激越和攻击行为。我们研究了匹莫范色林治疗后ADP的降低是否会降低相关的激越和攻击性。方法ACP-103-019是一项为期12周的随机、双盲、安慰剂对照研究，评价匹莫范色林（34 mg）减轻ADP患者精神病性症状的疗效。主要终点是第6周时神经精神病量表-疗养院版-精神病评分（NPI-NH-PS）较基线的变化。一项事后分析检查了与未发生幻觉和妄想减少的患者（无应答者）相比，接受匹莫范色林治疗的患者（精神病应答者定义为NPI-NH-PS较基线减少>= 50%，第6周）的激越和攻击性（NPI-NH结构域C [激越/攻击性]和Cohen-Mansfield激越量表-简表[CMAI-SF]）减少是否更大。结果匹莫范色林治疗的精神病症状缓解率>= 50%的患者（n = 44）在NPI-NH结构域C上的激越和攻击症状方面表现出更大的改善（第6周，最小二乘均值[LSM]差异=-3.64，t =-4.69，P < .0001）和CMAI-SF（第6周，LSM差异=-3.71，t =-2.01，P = .0483）。在基线时NPI-NH结构域C上有更严重激越和攻击行为的患者中也观察到精神病应答者和无应答者之间的差异（应答者，n = 26;无应答者，n = 13;第6周，LSM差异=-3.03，t =-2.44，P = 0.019）。结论：匹莫范色林治疗后精神病症状改善的ADP患者，伴随的激越和攻击行为也有所改善。
Objectives Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression. We investigated whether a reduction in ADP following pimavanserin treatment conferred a reduction in associated agitation and aggression. Methods ACP-103-019 was a 12-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy of pimavanserin (34 mg) in reducing psychotic symptoms in patients with ADP. The primary endpoint was change from baseline in Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS) at week six. A post hoc analysis examined whether there was a greater reduction in agitation and aggression (NPI-NH domain C [agitation/aggression] and Cohen-Mansfield Agitation Inventory-Short Form [CMAI-SF]) in pimavanserin-treated patients who experienced a reduction of hallucinations and delusions (psychosis responders defined as >= 50% reduction from baseline in NPI-NH-PS, week six) when compared with those who did not (nonresponders). Results Pimavanserin-treated patients with >= 50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI-NH domain C (week six, least squares mean [LSM] difference = -3.64,t= -4.69,P< .0001) and the CMAI-SF (week six, LSM difference = -3.71,t= -2.01,P= .0483) than nonresponders (n = 32). Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = -3.03,t= -2.44,P= .019). Conclusions Patients with ADP, who show improvement in psychotic symptoms after pimavanserin treatment, also experience an improvement in concomitant agitation and aggression.