Ye Wenyu, Fujikoshi Shinji, Nakahara Naohiro, Takahashi Michihiro, Ascher-Svanum Haya, Ohmori Tetsuro
Eli Lilly Japan KK, Kobe, Japan.
Eli Lilly Japan KK, Kobe, Japan; Terauchi-Takahashi Psychiatric Clinic, Ashiya, Japan.
Pragmat Obs Res. 2012 Jun 13;3:41-49. doi: 10.2147/POR.S28008. eCollection 2012.
The purpose of this study was to assess the 1-year clinical, functional, and safety-related outcomes following a switch to olanzapine of at least one typical antipsychotic drug in the previous regimen in the treatment of patients of schizophrenia in Japan.
Using data from a large 1-year prospective, multicenter, naturalistic study of olanzapine for the treatment of schizophrenia in Japan, patients who were switched from any oral typical antipsychotic to olanzapine were identified. Mixed models for repeated measures, controlling for baseline demographics, were utilized to assess outcomes for clinical and functional measures.
Of the 262 patients who switched from typical antipsychotics to olanzapine, 41% were outpatients and 59% were inpatients. Most of these patients were switched due to poor medication efficacy (71.0%) or medication intolerability (25.6%). Most patients (71.4%) completed the 1-year study. Clinically and statistically significant ( < 0.01) improvements were observed in patient illness severity and health-related quality of life, including improvements in global symptom severity and in positive, negative, depressive, and cognitive symptoms. Over half of the patients (58.3%) demonstrated a treatment response to olanzapine and 47.4% achieved symptom remission. Mean weight gain from baseline to endpoint was 2.31 ± 4.72 kg, with 30.4% of patients experiencing clinically significant weight gain (at least 7% of baseline weight).
During this 1-year naturalistic treatment of schizophrenia patients in Japan, switching from typical antipsychotics to olanzapine resulted in significant improvements in patients' clinical and functional outcomes. Approximately one-third of patients had clinically significant weight gain. These findings highlight the favorable benefit to risk profile of switching to olanzapine following failure on typical antipsychotics.
本研究旨在评估日本精神分裂症患者先前治疗方案中至少一种传统抗精神病药物换用奥氮平后的1年临床、功能及安全性相关结局。
利用一项针对日本奥氮平治疗精神分裂症的大型1年前瞻性、多中心、自然主义研究的数据,确定从任何口服传统抗精神病药物换用奥氮平的患者。采用重复测量混合模型,控制基线人口统计学特征,以评估临床和功能指标的结局。
在从传统抗精神病药物换用奥氮平的262例患者中,41%为门诊患者,59%为住院患者。这些患者大多数因药物疗效不佳(71.0%)或药物不耐受(25.6%)而换药。大多数患者(71.4%)完成了1年的研究。在患者疾病严重程度和健康相关生活质量方面观察到临床和统计学上的显著改善(<0.01),包括总体症状严重程度以及阳性、阴性、抑郁和认知症状的改善。超过一半的患者(58.3%)对奥氮平有治疗反应,47.4%的患者症状缓解。从基线到终点的平均体重增加为2.31±4.72千克,30.4%的患者出现临床上显著的体重增加(至少为基线体重的7%)。
在日本对精神分裂症患者进行的这1年自然主义治疗期间,从传统抗精神病药物换用奥氮平使患者的临床和功能结局得到显著改善。约三分之一的患者出现临床上显著的体重增加。这些发现凸显了在传统抗精神病药物治疗失败后换用奥氮平的有利获益风险比。