Treatment satisfaction and effectiveness of Lurasidone on quality of life and functioning in adult patients with schizophrenia in the real-world Italian clinical practice: a prospective 3-month observational study.

IF 3.6 3区 医学 Q1 PSYCHIATRY Annals of General Psychiatry Pub Date : 2024-11-05 DOI:10.1186/s12991-024-00531-z
Sergio De Filippis, Antonio Vita, Alessandro Cuomo, Emanuela Amici, Valeria Giovanetti, Ginevra Lombardozzi, Simone Pardossi, Luca Altieri, Andrea Cicale, Marisa Dosoli, Alessandro Galluzzo, Elena Invernizzi, Paola Rodigari, Patrizia Mascagni, Claudia Santini, Nathalie Falsetto, Marta Antonia Manes, Marco Micillo, Andrea Fagiolini
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: Lurasidone represents a valid option for the treatment of schizophrenia and positively affects subjective well-being, quality of life and satisfaction.

Trial registration: NCT06527885 retrospectively registered (01/08/2024).

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在意大利临床实践中,鲁拉西酮对成年精神分裂症患者生活质量和功能的治疗满意度和有效性:一项为期 3 个月的前瞻性观察研究。
背景:尽管第二代抗精神病药物(SGAs)已被证明是精神分裂症患者的有效治疗选择,但关于患者对这些药物的幸福感、生活质量和满意度的主观看法却明显缺乏证据。本研究旨在评估意大利临床实践中成年精神分裂症患者的治疗满意度以及鲁拉西酮对其生活质量和功能的影响:这是一项多中心、全国性、非干预、单臂、为期3个月的前瞻性研究。研究人员招募了对鲁拉西酮治疗不了解的患者,并对其进行了为期3个月的评估。符合条件的患者均为初诊为精神分裂症的成年人(≥18岁),他们正在接受鲁拉西酮治疗(首次[即对鲁拉西酮不敏感]),这是常规临床实践的一部分。疗效终点为服用鲁拉西酮6周和3个月后患者/护理人员治疗满意度的变化(用药治疗满意度问卷中的七点Likert量表)、患者生活质量和功能(QLS)、研究者评分的功能总体评估(CGI-S、IAQ)以及复发和住院次数:61名患者入组,59名患者完成了研究。基线时鲁拉西酮的中位剂量为37.00毫克/天。滴定时间的中位数为86.0天(最少28天,最多115天);剂量变化的中位数为1.0次。3个月观察期结束时,鲁拉西酮的中位剂量为每天74.00毫克。随着时间的推移,QoL和功能评分呈改善趋势,研究结束时与基线相比的平均变化为9.8。根据 CGI-S,"病情明显或严重 "的患者比例从基线到 3 个月持续下降,从 62.29% 降至 8.20%。随着时间的推移,患者的满意度不断提高,研究结束时,80.32%的患者表示 "比较满意"、"比较满意 "或 "非常满意"(包括63.93%的患者表示 "完全满意 "或 "非常满意")。没有因精神病复发/住院的报告。鲁拉西酮的耐受性良好,没有安全性问题,也没有因AE而停药:结论:鲁拉西酮是治疗精神分裂症的有效选择,对患者的主观幸福感、生活质量和满意度有积极影响:NCT06527885回顾性注册(01/08/2024)。
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来源期刊
CiteScore
6.60
自引率
2.70%
发文量
43
审稿时长
>12 weeks
期刊介绍: Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged. Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.
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