ObjectiveAn open-label extension study (NCT02873208) evaluated the long-term tolerability, safety, and efficacy of combination olanzapine/samidorphan (OLZ/SAM) treatment in patients with schizophrenia. This qualitative sub study explored perceptions of benefit, burden, and satisfaction with previous medications and OLZ/SAM.MethodsSemi-structured interviews (60 minutes; audio-recorded) were conducted. Interviewer sensitivity training, senior interviewer oversight, and a list of common medications to aid recall supported data collection. Interview transcripts were content coded and analyzed (NVivo v11.0).ResultsAll 41 patients reported a lifetime burden with schizophrenia adversely impacting employment, relationships, emotional health, social activities, and daily tasks. Hospitalization for schizophrenia management was another reported aspect of disease burden. Although most (n=32) patients reported previous medication benefits, side effects affecting physical, emotional/behavioral, and cognitive functioning were reported by all (n=41). Following OLZ/SAM treatment, 39/41 patients (95%) reported improvements in symptoms including hallucinations, paranoia, depression, sleep, and concentration. Furthermore, patients described improvements in self-esteem, social activities, relationships, and daily activities. Twenty-three patients (56%) reported side effects attributed to OLZ/SAM; lack of energy (n=12 [29%]) and dry mouth (n= 5 [12%]) were most common. Twenty-four (59%) patients were “very satisfied” with OLZ/SAM; most (n=35 [85%]) preferred to continue OLZ/SAM vs switching to another medication. As most substudy patients (n=40; 98%) completed the extension study, satisfied patients may be overrepresented in this analysis.ConclusionThis qualitative interview approach provided valuable insight into patients’ experiences with previous medications and OLZ/SAM. Overall, most patients reported treatment satisfaction and improvements in symptoms, function, and health-related quality of life with OLZ/SAM.FundingAlkermes, Inc.

中文翻译：

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评估精神分裂症患者的治疗益处、负担和满意度的定性临床试验退出访谈

目的一项开放标签扩展研究 (NCT02873208) 评估了奥氮平/沙米多芬 (OLZ/SAM) 联合治疗精神分裂症患者的长期耐受性、安全性和有效性。这项定性子研究探讨了对先前药物和 OLZ/SAM 的益处、负担和满意度的看法。方法进行了半结构化访谈（60 分钟；录音）。访调员敏感性培训、高级访调员监督以及帮助回忆的常用药物清单支持数据收集。访谈记录进行了内容编码和分析（NVivo v11.0）。结果所有 41 名患者都报告了精神分裂症的终生负担，对就业、人际关系、情绪健康、社交活动和日常任务产生了不利影响。精神分裂症住院治疗是疾病负担的另一个报告方面。尽管大多数 (n=32) 患者报告了以前的药物治疗益处，但所有 (n=41) 都报告了影响身体、情绪/行为和认知功能的副作用。OLZ/SAM 治疗后，39/41 名患者 (95%) 报告症状有所改善，包括幻觉、偏执、抑郁、睡眠和注意力集中。此外，患者描述了自尊、社交活动、人际关系和日常活动的改善。23 名患者 (56%) 报告了归因于 OLZ/SAM 的副作用；最常见的是精力不足（n=12 [29%]）和口干（n=5 [12%]）。24 名 (59%) 患者对 OLZ/SAM “非常满意”；大多数 (n=35 [85%]) 更愿意继续使用 OLZ/SAM，而不是改用另一种药物。由于大多数子研究患者 (n=40; 98%) 完成了扩展研究，因此在该分析中满意的患者可能过多。结论这种定性访谈方法提供了对患者使用先前药物和 OLZ/SAM 的经验的宝贵见解。总体而言，大多数患者报告了 OLZ/SAM 的治疗满意度和症状、功能和健康相关生活质量的改善。FundingAlkermes, Inc.