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首页> 外文期刊>Neuropsychiatric Disease and Treatment >Safety and tolerability of switching to asenapine from other antipsychotic agents: pooled results from two randomized multicenter trials in stable patients with persistent negative symptoms in schizophrenia
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Safety and tolerability of switching to asenapine from other antipsychotic agents: pooled results from two randomized multicenter trials in stable patients with persistent negative symptoms in schizophrenia

机译：从其他抗精神病药转向阿塞那平的安全性和耐受性：两项针对精神分裂症持续阴性症状的稳定患者的随机多中心试验的两项汇总结果

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Background: In clinical practice, clinicians often need to switch antipsychotic medications in patients with schizophrenia to optimize treatment outcomes. Here, we describe the safety and tolerability of switching existing antipsychotic treatments to asenapine or olanzapine monotherapy using various switching regimens.Methods: Data were pooled from 949 patients in two 26-week randomized double-blind studies. Patients with persistent negative symptoms of schizophrenia, stable for at least 5 months prior to screening and 1 additional month before randomization, were randomized to and treated with either asenapine (n = 485) or olanzapine (n = 464), and were tapered off existing antipsychotic(s) at variable rates within 28 days.Results: Prior to randomization, most patients were treated with second-generation antipsychotics (SGAs) (asenapine: 79.6%; olanzapine: 78.2%) and first-generation antipsychotics (FGAs) (31.1%; 29.7%), while depot formulations were used by 12.4% and 11.4%, respectively. Median time to taper off previous antipsychotics was 7 days, with approximately 40% of patients abruptly discontinuing their previous medication. Similar percentages of patients in each group reported at least one adverse event (AE) (asenapine: 76.9%; olanzapine: 75.2%). The majority of AEs occurred within the first 28 days. The most frequently reported AEs were somnolence, insomnia, and headache. The incidence of AEs in patients switching from SGAs, FGAs, or depot medications was similar between asenapine and olanzapine (77.5% vs 74.6%, 75.5% vs 79.7%, 85.0% vs 86.8%, respectively). AEs were more frequent in subjects previously treated with two antipsychotics (asenapine: 79.4%; olanzapine: 83.9%) versus one antipsychotic (asenapine: 76.3%; olanzapine: 72.2%) in the switch period.Conclusion: The presented data from post hoc pooled analyses may provide practical guidance for physicians switching partially stabilized patients with schizophrenia and persistent negative symptoms to asenapine or olanzapine.
机译：背景：在临床实践中，临床医生通常需要对精神分裂症患者使用抗精神病药物，以优化治疗效果。在这里，我们描述了使用各种转换方案将现有的抗精神病药物转换为阿塞那平或奥氮平单药治疗的安全性和耐受性。方法：在两项为期26周的随机双盲研究中，从949名患者中收集了数据。患有精神分裂症持续阴性症状，在筛选前至少稳定5个月，在随机分组前稳定1个月的患者被随机分配到阿塞那平（n = 485）或奥氮平（n = 464）并接受治疗，并逐渐减少结果：在随机分组之前，大多数患者接受了第二代抗精神病药（SGA）（阿塞那平：79.6％;奥氮平：78.2％）和第一代抗精神病药（FGA）（31.1）的治疗。 ％; 29.7％），而仓库配方分别使用了12.4％和11.4％。逐渐减少以前使用的抗精神病药的时间为7天，大约40％的患者突然停药。每组患者报告至少一种不良事件（AE）的百分比相似（阿塞那平：76.9％;奥氮平：75.2％）。大部分AE发生在头28天内。报道最频繁的AE是嗜睡，失眠和头痛。在阿塞那平和奥氮平之间，从SGA，FGA或储库药物转换的患者中AE的发生率相似（分别为77.5％vs 74.6％，75.5％vs 79.7％，85.0％vs 86.8％）。在转换期之前，先前接受过两种抗精神病药（阿塞那平：79.4％;奥氮平：83.9％）的受试者的AE发生频率高于一种抗精神病药（阿塞那平：76.3％;奥氮平：72.2％）。分析可能为医生将部分稳定的精神分裂症和持续阴性症状的患者转换为阿塞那平或奥氮平提供实用指导。

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