Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
Department of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, United States.
J Affect Disord. 2019 Mar 1;246:217-223. doi: 10.1016/j.jad.2018.12.023. Epub 2018 Dec 17.
Few studies have assessed the treatment of tardive dyskinesia (TD) in patients with primary mood disorders who are managed with antipsychotics. The effects of once-daily valbenazine on TD were evaluated in adults with a bipolar or depressive disorder.
Data were pooled from two 6-week double-blind placebo-controlled trials (KINECT 2 and KINECT 3; 114 mood participants) and a long-term blinded extension study (KINECT 3 extension; 77 mood participants) of valbenazine in adults with TD. Efficacy assessments included Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7), Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD), and Patient Global Impression of Change (PGIC). Safety assessments included treatment-emergent adverse events (TEAEs), Young Mania Rating Scale, and Montgomery-Åsberg Depression Rating Scale.
At Week 6, mean improvements in AIMS total score were significantly greater with valbenazine versus placebo (40 mg/day, -3.1 [P < 0.01]; 80 mg/day, -3.5 [P < 0.001]; placebo, -0.9). Significant differences between valbenazine (80 mg/day) and placebo were also found for Week 6 AIMS response (≥50% total score improvement) and CGI-TD response ("much improved" or "very much improved"), but not PGIC response. Sustained improvements in AIMS, CGI-TD, and PGIC were found through 48 weeks. Valbenazine was generally well tolerated, with no unexpected TEAEs, worsening in psychiatric symptoms, or emergence of suicidality.
Pooled analyses were conducted post hoc, and neither study was designed to focus solely on mood disorder patients.
In participants with primary mood disorders, once-daily treatment with valbenazine was generally well tolerated and resulted in 6-week and sustained TD improvements.
很少有研究评估抗精神病药物治疗原发性心境障碍患者的迟发性运动障碍（TD）。本文评估了每日一次 valbenazine 治疗 TD 的效果，入组患者为患有双相或抑郁障碍的成年人。
数据来自 valbenazine 治疗 TD 成人患者的两项 6 周双盲安慰剂对照试验（KINECT 2 和 KINECT 3；114 名心境障碍参与者）和一项长期盲法扩展研究（KINECT 3 扩展；77 名心境障碍参与者）的汇总分析。疗效评估包括异常不自主运动量表（AIMS）总分（项目 1-7 的总和）、迟发性运动障碍临床总体印象变化量表（CGI-TD）和患者总体印象变化量表（PGIC）。安全性评估包括治疗出现的不良事件（TEAEs）、Young 躁狂评定量表和 Montgomery-Åsberg 抑郁评定量表。
在第 6 周，与安慰剂相比，valbenazine 治疗组 AIMS 总分的平均改善显著更大（40mg/天，-3.1[P<0.01]；80mg/天，-3.5[P<0.001]；安慰剂，-0.9）。在第 6 周时，valbenazine（80mg/天）与安慰剂相比，AIMS 应答（总分改善≥50%）和 CGI-TD 应答（“明显改善”或“非常明显改善”）也存在显著差异，但 PGIC 应答没有差异。在第 48 周时，仍观察到 AIMS、CGI-TD 和 PGIC 的持续改善。Valbenazine 通常具有良好的耐受性，无意外 TEAEs、精神症状恶化或自杀意念出现。
汇总分析是事后进行的，并且没有一项研究专门针对心境障碍患者。
在原发性心境障碍患者中，每日一次 valbenazine 治疗通常具有良好的耐受性，并导致 TD 在 6 周和持续时间上的改善。
