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Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics

机译:非急性精神分裂症患者先前曾用其他口服抗精神病药治疗失败的帕潘立酮缓释药

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摘要

Objective: This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design. Research design and methods: Patients were recruited from 23 countries. Adults with non-acute schizophrenia (n = 1812), previously unsuccessfully treated with other oral antipsychotics, were transitioned to paliperidone ER and prospectively treated for 6 months. Main outcome measures: Primary efficacy outcome for patients switching for the main reason of lack of efficacy was ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores. For patients switching for main reasons other than lack of efficacy, primary outcome was non-inferiority in efficacy compared with the previous medication. Results: Among the lack-of-efficacy group, 61% achieved a ≥ 20% improvement in PANSS total scores from baseline to endpoint. For switchers from other than the lack-of-efficacy group, efficacy maintenance after switching to paliperidone ER was confirmed. Clinically relevant and statistically significant symptomatic improvements occurred for each patient group based on main reason for switching. Conclusion: Paliperidone ER was well tolerated and associated with a meaningful clinical response in patients who switched from other oral antipsychotics, with insomnia and anxiety as most frequent side-effects.
机译:目的:本研究在实际设计中探索了灵活剂量帕潘立酮缓释(ER)的相关结果。研究设计和方法:患者来自23个国家。以前未曾用其他口服抗精神病药治疗失败的非急性精神分裂症(n = 1812)成人,转用帕潘立酮ER治疗,预期治疗6个月。主要结局指标:因缺乏疗效的主要原因而进行转换的患者的主要疗效结局为阳性和阴性综合征量表(PANSS)总评分提高≥20%。对于因主要原因而不是缺乏疗效而换药的患者,主要结局是与以前的药物相比疗效不逊色。结果:在缺乏效能的组中,从基线到终点的PANSS总得分提高了61%以上。对于非效率低下人群以外的其他转换者,已确认转换为帕潘立酮ER后的疗效得以维持。根据切换的主要原因,每个患者组的临床相关症状和统计学意义上的症状改善都发生了。结论:帕潘立酮ER耐受性好,并且在转用其他口服抗精神病药的患者中具有有意义的临床反应,失眠和焦虑是最常见的副作用。

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