缬苯那嗪对迟发性运动障碍老年人（≥65岁）的改善：2项长期研究的事后分析

IF 4.5 2区医学 Q1 PSYCHIATRY

Journal of Clinical Psychiatry Pub Date : 2025-04-23 DOI:10.4088/JCP.24m15550

Martha Sajatovic, George S Alexopoulos, Eric Jen, Khody Farahmand, Celia Zinger

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引用次数: 0

摘要

目的：评价缬苯那嗪（40或80 mg）每日一次治疗老年人（≥65岁）迟发性运动障碍（TD）的长期疗效。方法：数据来自两项为期48周的研究，KINECT 3扩展（NCT02274558）和KINECT 4 (NCT02405091)，并在老年参与者（≥65岁）和第48周按年龄组进行分析(结果：在合并分析人群（N = 304）中，55(18.1%)≥65岁。≥65岁年龄组AIMS总分（±标准误差）与基线相比的平均变化从第8周开始增加(-4.5±0.7；至第48周（-8.8±0.9）。这些稳健和持续的改善与第8、24和48周达到缓解阈值的百分比一致：AIMS≥30%改善（58.0%、88.5%和89.3%）；AIMS改善≥50%(40.0%、65.4%、82.1%)；CGI-TD评分≤2分（33.3%、88.5%、92.9%）；PGIC评分≤2分（43.1%、84.6%、85.7%）。老年人最常见的teae是尿路感染（10.9%）和嗜睡（10.9%）。在研究期间，精神状态保持稳定。结论：缬苯那嗪对接受48周治疗的老年人安全有效。根据临床医生评估（AIMS, CGI-TD）和患者报告（PGIC），长期治疗导致实质性和持续的TD改善，对精神稳定性没有影响。

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Improvements Over Time with Valbenazine in Elderly Adults (≥65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies.

Objective: To evaluate the long-term effects of once-daily valbenazine (40 or 80 mg) on tardive dyskinesia (TD) in elderly adults (age ≥65 years).

Methods: Data were pooled from two 48-week studies, KINECT 3 extension (NCT02274558) and KINECT 4 (NCT02405091), with analyses performed over time in elderly participants (≥65 years) and at Week 48 by age group (<65 and ≥65 years). Outcomes included mean change in Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response thresholds (≥30% and ≥50% improvement from baseline), and response threshold for Clinical Global Impression of Change-TD (CGI-TD) and Patient Global Impression of Change (PGIC), defined as a score ≤2 ("much improved" or "very much improved"). Safety assessments included treatment-emergent adverse events (TEAEs) and psychiatric symptom scales (eg, Positive and Negative Syndrome Scale).

Results: Of the pooled analysis population (N = 304), 55 (18.1%) were ≥65 years of age. The mean change from baseline in AIMS total score (±standard error) in the ≥65-year age group increased from Week 8 (-4.5 ± 0.7; first visit after dose escalation in KINECT 4) through Week 48 (-8.8 ± 0.9). These robust and sustained improvements were consistent with the percentage who met response thresholds at Weeks 8, 24, and 48: AIMS ≥30% improvement (58.0%, 88.5%, and 89.3%); AIMS ≥50% improvement (40.0%, 65.4%, and 82.1%); CGI-TD score ≤2 (33.3%, 88.5%, and 92.9%); and PGIC score ≤2 (43.1%, 84.6%, and 85.7%). The most common TEAEs among elderly participants were urinary tract infections (10.9%) and somnolence (10.9%). Psychiatric status remained stable during the studies.

Conclusion: Valbenazine was safe and effective in elderly adults who received up to 48 weeks of treatment. Long-term treatment led to substantial and sustained TD improvements per clinician assessment (AIMS, CGI-TD) and patient report (PGIC), with no impact on psychiatric stability.

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来源期刊

Journal of Clinical Psychiatry 医学-精神病学

CiteScore

7.40

自引率

1.90%

发文量

审稿时长

3-8 weeks

期刊介绍： For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.