Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study
Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study
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DOI：
10.1159/000471507
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发表时间：
2017-01-01
影响因子：
2.4
通讯作者：
Boeve, Bradley F.
中科院分区：
文献类型：
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作者：
Lapid, Maria I.;Kuntz, Karen M.;Boeve, Bradley F.
背景/目的：睡眠过度在路易体痴呆（DLB）中很常见。我们评估了阿莫达非尼治疗与DLB相关的嗜睡症的疗效、安全性和耐受性。方法：我们进行了为期12周的试点试验，阿莫达非尼治疗（125-250毫克口服每日）DLB门诊患者嗜睡。患者接受神经系统检查，神经心理电池，实验室检查，心电图，多导睡眠图。在第2、4、8和12周评估疗效。安全性评估包括实验室检查、QTc间期和心率。通过不良事件分析评估耐受性。采用末次观察值结转法分析数据。结果：20名参与者中，17人完成了方案。中位年龄为72岁，大多数参与者为男性（80%），大多数有配偶作为照顾者。第12周时，埃普沃思嗜睡量表（p < 0.001）、觉醒维持试验（p = 0.003）和临床总体印象变化（p < 0.001）评分改善。第4周时，神经精神量表总分（p = 0.003）、幻视（p = 0.003）和激越（p = 0.02）改善。第12周时，护理人员的整体生活质量有所改善（p = 0.004）。未发生不良事件。结论：这些初步研究数据表明，在患有DLB的嗜睡患者中，阿莫达非尼治疗可改善嗜睡和觉醒以及合理的安全性和耐受性。我们的研究结果为管理这些患者的嗜睡提供了药物策略。(C)2017 S. Karger AG，巴塞尔
Background/Aims: Hypersomnia is common in dementia with Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability of armodafinil for hypersomnia associated with DLB. Methods: We performed a 12-week pilot trial of armodafinil therapy (125-250 mg orally daily) in DLB outpatients with hypersomnia. The patients underwent neurologic examinations, a neuropsychological battery, laboratory testing, electrocardiography, and polysomnography. Efficacy was assessed at 2, 4, 8, and 12 weeks. Safety assessment included laboratory examinations, QTc interval, and heart rate. Tolerability was assessed by analysis of adverse events. Data were analyzed using the last-observation-carried-forward method. Results: Of 20 participants, 17 completed the protocol. The median age was 72 years, most of the participants were men (80%), and most had spouses as caregivers. The Epworth Sleepiness Scale (p < 0.001), Maintenance of Wakefulness Test (p = 0.003), and Clinical Global Impression of Change (p < 0.001) scores improved at week 12. The Neuropsychiatric Inventory total score (p = 0.003), visual hallucinations (p = 0.003), and agitation (p = 0.02) improved at week 4. Caregiver overall quality of life improved at week 12 (p = 0.004). No adverse events occurred. Conclusion: These pilot data suggest improvements in hypersomnia and wakefulness and reasonable safety and tolerability of armodafinil therapy in hypersomnolent patients with DLB. Our findings inform the use of pharmacologic strategies for managing hypersomnolence in these patients. (C) 2017 S. Karger AG, Basel