De Filippis Sergio, Vita Antonio, Cuomo Alessandro, Amici Emanuela, Giovanetti Valeria, Lombardozzi Ginevra, Pardossi Simone, Altieri Luca, Cicale Andrea, Dosoli Marisa, Galluzzo Alessandro, Invernizzi Elena, Rodigari Paola, Mascagni Patrizia, Santini Claudia, Falsetto Nathalie, Manes Marta Antonia, Micillo Marco, Fagiolini Andrea
Neuropsychiatric Clinic, Villa Von Siebenthal, Genzano di Roma, Italy.
Department of Mental Health and Addiction Services, University of Brescia, Spedali Civili Hospital, Brescia, Italy.
Ann Gen Psychiatry. 2024 Nov 5;23(1):43. doi: 10.1186/s12991-024-00531-z.
Although second-generation antipsychotics (SGAs) have proven to be effective therapeutic options for patients with schizophrenia, there is a notable lack of evidence on patients' subjective perspectives regarding their well-being, quality of life, and satisfaction with these medications. This study aimed to evaluate the treatment satisfaction and effectiveness of lurasidone on quality of life and functioning in adult patients with schizophrenia in real-world Italian clinical practice.
This was a multicentre, national, non-interventional, single-arm, 3-month prospective study. Patients who were naive to lurasidone treatment and whose treating physician had decided to start them on this medication were enrolled and evaluated over a 3-month period. Eligible patients were adults (≥ 18 years of age) with a primary diagnosis of schizophrenia who were being treated with lurasidone (for the first time [i.e., they were lurasidone naive]) as part of routine clinical practice. Efficacy endpoints were changes in patient/caregiver treatment satisfaction (seven-point Likert scale from the Treatment Satisfaction Questionnaire for Medication), patient quality of life and functioning (QLS), investigator-rated global assessment of functioning (CGI-S, IAQ) after 6 weeks and 3 months of lurasidone, and number of relapses and hospitalizations.
Sixty-one patients were enrolled and 59 completed the study. The median dosage of lurasidone at baseline was 37.00 mg/day. The median duration of titration was 86.0 days (Min 28; Max 115 days); the median number of dosage changes was 1.0. At the end of 3-month observation period, the median dose of lurasidone was 74.00 mg/day. QoL and Functioning Score showed a trend of improvement over time, reaching a mean change from baseline of 9.8 at the end of the study. According to the CGI-S, the percentage of patients who were "markedly or severely ill" showed a continuous decrease from baseline to 3 months, from 62.29% to 8.20%. Patient satisfaction increased over time, with 80.32% of patients reporting that they were somewhat, fairly, or very satisfied (including 63.93% who were completely or very satisfied) at the end of the study. No relapses/hospitalizations for psychiatric reasons were reported. Lurasidone was well tolerated with no safety concerns or discontinuations due to AEs.
Lurasidone represents a valid option for the treatment of schizophrenia and positively affects subjective well-being, quality of life and satisfaction.
NCT06527885 retrospectively registered (01/08/2024).
尽管第二代抗精神病药物（SGAs）已被证明是治疗精神分裂症患者的有效选择，但关于患者对自身幸福感、生活质量以及对这些药物满意度的主观观点，明显缺乏相关证据。本研究旨在评估在意大利现实临床实践中，鲁拉西酮对成年精神分裂症患者的治疗满意度以及对生活质量和功能的有效性。
这是一项多中心、全国性、非干预性、单臂、为期3个月的前瞻性研究。纳入首次接受鲁拉西酮治疗且其主治医生决定让他们开始使用这种药物的患者，并在3个月期间进行评估。符合条件的患者为年龄≥18岁、原发性诊断为精神分裂症且作为常规临床实践一部分正在接受鲁拉西酮治疗（首次使用[即他们对鲁拉西酮无用药史]）的成年人。疗效终点包括患者/照料者治疗满意度（来自药物治疗满意度问卷的七点李克特量表）、患者生活质量和功能（QLS）、研究者评定的功能总体评估（CGI-S、IAQ）在鲁拉西酮治疗6周和3个月后的变化，以及复发和住院次数。
61名患者入组，59名完成研究。基线时鲁拉西酮的中位剂量为37.00毫克/天。滴定的中位持续时间为86.0天（最小值28天；最大值115天）；剂量变化的中位次数为1.0次。在3个月观察期结束时，鲁拉西酮的中位剂量为74.00毫克/天。生活质量和功能评分随时间呈现改善趋势，在研究结束时相对于基线的平均变化达到9.8。根据CGI-S，“明显或严重患病”的患者百分比从基线到3个月持续下降，从62.29%降至8.20%。患者满意度随时间增加，在研究结束时，80.32%的患者报告他们有点、相当或非常满意（包括63.93%完全或非常满意的患者）。未报告因精神疾病原因导致的复发/住院情况。鲁拉西酮耐受性良好，未出现因不良事件导致的安全问题或停药情况。
鲁拉西酮是治疗精神分裂症的有效选择，对主观幸福感、生活质量和满意度有积极影响。
NCT06527885，回顾性注册（2024年8月1日）。
