Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study

Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study
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DOI:
10.1007/s00213-002-1344-3
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发表时间:
2003-04-01
期刊:
影响因子:
3.4
通讯作者:
Ingenito, GG
Ingenito, GG
中科院分区:
医学3区
文献类型:
--
作者:
Casey, DE;Carson, WH;Ingenito, GG

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理由:将患者从一种抗精神病药物转换为另一种抗精神病药物可能导致耐受性问题或一过性症状加重。重要的是要比较转换策略,以确定哪些方法产生最好的患者结果。目的:研究三种给药策略将慢性稳定期精神分裂症患者从目前的口服抗精神病药单药治疗转换为每日一次口服阿立哌唑单药治疗的疗效、安全性和耐受性。方法:在这项为期8周的开放标签门诊研究中,患者被随机分配至:1)立即开始30 mg/天阿立哌唑治疗,同时立即停用当前抗精神病药物; 2)立即开始30 mg/天阿立哌唑治疗,同时在2周内逐渐停用当前抗精神病药物;或3)在2周内将阿立哌唑剂量上调至30 mg/天,同时逐渐停用当前抗精神病药物。疗效评估包括PANSS、CGI-S和CGI-I评分。安全性评估包括:不良事件(AE)记录、锥体外系症状(EPS)评价、生命体征、ECG和临床实验室检查。结果在研究期间,与基线相比,所有三组中阿立哌唑的疗效均得到了数值改善。所有组间AE的总体发生率大致相当,AE的严重程度通常为轻度至中度,且有时间限制。各组间因AE而停药的情况相当。任何组均未发生EPS恶化。三组间转换为阿立哌唑后体重和血浆催乳素水平的降低相当。结论:所评估的三种策略中的任何一种都可以安全地用于将患者从抗精神病药单药治疗转为阿立哌唑治疗。此外,患者的症状可能会继续改善后切换到阿立哌唑。
Rationale: Switching patients from one antipsychotic to another can lead to tolerability problems or transient symptom exacerbations. It is important to compare switching strategies to determine which methods produce the best possible patient outcomes. Objective: To investigate the efficacy, safety and tolerability of three dosing strategies for switching chronic, stable patients with schizophrenia from current oral antipsychotic monotherapy to once-daily oral aripiprazole monotherapy. Method: Patients in this 8-week, open-label, outpatient study were randomized to: 1) immediate initiation of 30 mg/day aripiprazole with simultaneous immediate discontinuation of current antipsychotic; 2) immediate initiation of 30 mg/day aripiprazole while tapering off cur-rent antipsychotic over 2 weeks; or 3) up-titrating aripiprazole to 30 mg/day over 2 weeks, while simultaneously tapering off current antipsychotic. Efficacy assessments included PANSS, CGI-S, and CGI-I scores. Safety assessments included: adverse events (AEs) recording, evaluation of extrapyramidal symptoms (EPS), vital signs, ECG, and clinical laboratory tests.Results Efficacy with aripiprazole was maintained during the study with numerical improvements compared with baseline in all three groups. The overall incidence of AEs was broadly comparable across all groups, and AEs were generally mild to moderate in severity and time-limited. Discontinuations due to AEs were comparable across the groups. No deterioration in EPS occurred in any group. The reduction in body weight and plasma prolactin levels following switch to aripiprazole were comparable across the three groups. Conclusion: Any of the three strategies evaluated can be used safely for switching patients to aripiprazole from antipsychotic monotherapy. Furthermore, patients' symptoms may continue to improve after switching to aripiprazole.