Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials.

IF 2.2 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Zahinoor Ismail, Shivani Kapadia, Anton M Palma, Murat Yildirim, Anja Farovik
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Abstract

Objective: For people with schizophrenia and their caregivers, anxiety is among the top symptoms for which they would like an effective treatment. The aims of this post hoc analysis of clinical trial data were to characterize the efficacy, safety and tolerability of brexpiprazole on anxiety symptoms in adults with schizophrenia, and to investigate the relationships between anxiety symptoms, functioning, and patient life engagement.

Methods: Data were pooled for brexpiprazole 2-4 mg/day and placebo from three six-week, randomized, double-blind trials of brexpiprazole in adult inpatients with schizophrenia (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380) and for brexpiprazole 1-4 mg/day from two 52-week, open-label extension trials (NCT01397786, NCT01810783). People with comorbid anxiety disorders were not enrolled. In this post hoc analysis, anxiety was measured by a single item (G2) of the Positive and Negative Syndrome Scale (PANSS), functioning was measured by the Personal and Social Performance scale, and patient life engagement was measured by a 14-item PANSS subset. Least squares mean changes from baseline were calculated using a mixed model for repeated measures. Anxiety response was defined using two definitions: (1) PANSS G2 improvement of ≥1 point (a clinically interpretable score change) from baseline to Week 6, and (2) PANSS G2 score of <3 points (anxiety symptoms reduced to "minimal" or "absent") at Week 6 for the subgroup who had anxiety at baseline (G2 score ≥3). This was an exploratory, hypothesis-generating analysis with no correction for multiple comparisons.

Results: Anxiety at baseline (G2 score ≥3) was present in 763/868 (87.9%) participants on brexpiprazole, and 449/517 (86.8%) on placebo. At Week 6, least squares mean change from baseline in G2 score favored brexpiprazole versus placebo: mean difference, -0.19; 95% confidence interval, -0.33 to -0.06; p = .005; Cohen's d effect size, 0.19. Anxiety response for brexpiprazole and placebo, respectively, was shown in 547/863 (63.4%) and 291/515 (56.5%) participants (p = .012; response definition 1), and 283/541 (52.3%) and 135/303 (44.6%) participants (p = .036; response definition 2). Functioning and patient life engagement improved regardless of whether participants' anxiety improved. Long-term data suggested maintenance of treatment effects. Adverse events were consistent with prior analyses.

Conclusion: Exploratory analyses suggest that brexpiprazole may help in the management of anxiety symptoms, functioning, and patient life engagement - important outcomes for people with schizophrenia.

Brexpiprazole治疗精神分裂症患者的焦虑症状:短期和长期试验的汇总分析
目的:对于精神分裂症患者和他们的照顾者来说,焦虑是他们最希望得到有效治疗的症状之一。本临床试验数据事后分析的目的是表征brexpiprazole对成年精神分裂症患者焦虑症状的有效性、安全性和耐受性,并调查焦虑症状、功能和患者生活参与之间的关系。方法:汇总布雷克斯哌唑2-4 mg/天和安慰剂的数据,这些数据来自3个为期6周的布雷克斯哌唑成人住院精神分裂症患者的随机双盲试验(ClinicalTrials.gov识别号:NCT01396421、NCT01393613、NCT01810380),以及布雷克斯哌唑1-4 mg/天的数据来自2个为期52周的开放标签扩展试验(NCT01397786、NCT01810783)。患有共病性焦虑症的人没有被纳入研究。在这个事后分析中,焦虑是通过正面和负面综合症量表(PANSS)的一个项目(G2)来测量的,功能是通过个人和社会表现量表来测量的,病人的生活参与是通过一个14个项目的PANSS子集来测量的。使用重复测量的混合模型计算基线的最小二乘平均值变化。焦虑反应的定义采用两种定义:(1)从基线到第6周PANSS G2改善≥1分(临床可解释的评分变化),(2)结果的PANSS G2评分:布雷哌唑组763/868(87.9%)参与者存在基线焦虑(G2评分≥3),安慰剂组449/517(86.8%)参与者存在基线焦虑(G2评分≥3)。在第6周,最小二乘平均变化从基线来看,brexpiprazole优于placebo:平均差值为-0.19;95%置信区间为-0.33 ~ -0.06;p = 0.005;科恩效应值为0.19。brexpiprazole和placebo分别在547/863(63.4%)和291/515(56.5%)参与者(p = 0.012;应答定义1)和283/541(52.3%)和135/303(44.6%)参与者(p = 0.036;应答定义2)中显示焦虑反应。无论参与者的焦虑是否改善,功能和患者生活参与度都有所改善。长期数据显示治疗效果维持。不良事件与先前的分析一致。结论:探索性分析表明,brexpiprazole可能有助于控制焦虑症状、功能和患者生活参与——这是精神分裂症患者的重要结局。
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来源期刊
Current Medical Research and Opinion
Current Medical Research and Opinion 医学-医学:内科
CiteScore
4.40
自引率
4.30%
发文量
247
审稿时长
3-8 weeks
期刊介绍: Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance
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