Maruyama Hidenori, Sano Fumiya, Sakaguchi Reiko, Okamoto Keisuke, Miura Itaru
Medical Science, Sumitomo Pharma Co., Ltd, Osaka, Japan.
Department of Data Science, Drug Development Division, Sumitomo Pharma Co., Ltd, Tokyo, Japan.
Neuropsychiatr Dis Treat. 2024 Jul 24;20:1453-1463. doi: 10.2147/NDT.S466479. eCollection 2024.
To evaluate the effect of lurasidone on a new, patient Life Engagement scale in schizophrenia.
This post-hoc analysis included participants (ages 18 to 74) diagnosed with schizophrenia who were randomized to lurasidone (40 mg/day) or placebo in a 6-week double-blind efficacy study and those who continued in a subsequent 12-week open-label extension study during which patients received either 40 or 80/mg day lurasidone (flexibly dosed). Change in life engagement was measured using the Positive and Negative Syndrome Scale (PANSS) 11-item Life Engagement subscale score, and individual subscale items, at week 6 during the double-blind phase and extension phase week 12 during the open-label extension phase.
Analysis focused on 478 subjects randomized to lurasidone or placebo during the 6-week trial, and 146 who received lurasidone during the extension phase. During the 6-week trial, there was a significantly greater change on the PANSS Life Engagement subscale score from baseline to week 6 in the lurasidone group compared to the placebo group (mean changes of -6.4 and -4.8, respectively, p = 0.006; effect size = 0.27). Further improvement was evident during the extension phase for patients who received lurasidone in both phases, with a mean change from double-blind baseline to week 12 of the open-label treatment phase of -10.1 on in PANSS Life Engagement subscale.
This post-hoc analysis suggests that lurasidone may improve life engagement in patients with schizophrenia, a meaningful outcome from patients' perspective. Further studies are needed to confirm this effect.
Trial registration: EudraCT Numbers: 2016-000060-42; 2016-000061-23.
评估鲁拉西酮对精神分裂症患者新型生活参与量表的影响。
这项事后分析纳入了年龄在18至74岁之间、被诊断为精神分裂症的参与者，这些参与者在一项为期6周的双盲疗效研究中被随机分配至鲁拉西酮组（40毫克/天）或安慰剂组，以及那些继续参加随后为期12周的开放标签扩展研究的患者，在该扩展研究中患者接受40或80毫克/天的鲁拉西酮治疗（剂量灵活调整）。在双盲阶段的第6周以及开放标签扩展阶段的第12周，使用阳性和阴性症状量表（PANSS）的11项生活参与分量表得分以及各个分量表项目来测量生活参与度的变化。
分析聚焦于在为期6周的试验中被随机分配至鲁拉西酮组或安慰剂组的478名受试者，以及在扩展阶段接受鲁拉西酮治疗的146名受试者。在为期6周的试验期间，与安慰剂组相比，鲁拉西酮组从基线到第6周时PANSS生活参与分量表得分的变化显著更大（平均变化分别为-6.4和-4.8，p = 0.006；效应大小 = 0.27）。对于在两个阶段均接受鲁拉西酮治疗的患者，在扩展阶段有进一步改善，从双盲基线到开放标签治疗阶段第12周时，PANSS生活参与分量表的平均变化为-10.1。
这项事后分析表明，鲁拉西酮可能改善精神分裂症患者的生活参与度，从患者角度来看这是一个有意义的结果。需要进一步研究来证实这种效果。
试验注册：欧盟临床试验注册号：2016 - 000060 - 42；2016 - 000061 - 23。
