Abstract：
UNASSIGNED: Tardive dyskinesia (TD) and Huntington\'s disease (HD)-associated chorea are persistent and disabling hyperkinetic disorders that can be treated with vesicular monoamine transporter type 2 (VMAT2) inhibitors, including the recently approved once-daily (QD) formulation of deutetrabenazine (DTBZ ER). While its efficacy and safety profile have not been directly investigated, currently available data confirms bioequivalence and similar bioavailability to the twice-daily formulation (DTBZ BID).
UNASSIGNED: The authors briefly review the pivotal trials establishing efficacy of DTBZ for TD and HD-associated chorea, the pharmacokinetic data for bioequivalence between QD and BID dosing of DTBZ, as well as dose proportionality evidence, titration recommendations, and safety profile for DTBZ ER.
UNASSIGNED: Long-term data show that DTBZ is efficacious and well tolerated for the treatment of TD and HD-associated chorea. DTBZ ER likely demonstrates therapeutic equivalence with no new safety signals. Due to the lack of comparative clinical trial data, no evidence-based recommendation about choice of VMAT2 inhibitor or switching between VMAT2 inhibitors can be made about best practice. Ultimately, QD dosing may offer the chance of improved medication adherence, an important consideration in patients with complex treatment regimens and/or patients with cognitive decline.
UNASSIGNED: The authors briefly review the pivotal trials establishing efficacy of DTBZ for TD and HD-associated chorea, the pharmacokinetic data for bioequivalence between QD and BID dosing of DTBZ, as well as dose proportionality evidence, titration recommendations, and safety profile for DTBZ ER.
UNASSIGNED: Long-term data show that DTBZ is efficacious and well tolerated for the treatment of TD and HD-associated chorea. DTBZ ER likely demonstrates therapeutic equivalence with no new safety signals. Due to the lack of comparative clinical trial data, no evidence-based recommendation about choice of VMAT2 inhibitor or switching between VMAT2 inhibitors can be made about best practice. Ultimately, QD dosing may offer the chance of improved medication adherence, an important consideration in patients with complex treatment regimens and/or patients with cognitive decline.
摘要：
■迟发性运动障碍（TD）和亨廷顿病（HD）相关的舞蹈症是持续性和致残的多动障碍，可以用2型囊泡单胺转运蛋白（VMAT2）抑制剂治疗，包括最近批准的每日一次（QD）的deutrabenazine（DTBZER）制剂。虽然其疗效和安全性尚未得到直接调查，目前可获得的数据证实了生物等效性和与每日两次制剂(DTBZBID)相似的生物利用度.
■作者简要回顾了确定DTBZ对TD和HD相关舞蹈症疗效的关键试验，DTBZ的QD和BID给药之间生物等效性的药代动力学数据，以及剂量比例证据，滴定建议，和DTBZER的安全配置文件。
■长期数据表明，DTBZ对TD和HD相关舞蹈病的治疗有效且耐受性良好。DTBZER可能证明治疗等效，没有新的安全信号。由于缺乏比较临床试验数据,关于最佳实践,没有关于选择VMAT2抑制剂或在VMAT2抑制剂之间切换的循证建议.最终,QD给药可能提供改善药物依从性的机会，复杂治疗方案患者和/或认知功能减退患者的重要考虑因素。
■作者简要回顾了确定DTBZ对TD和HD相关舞蹈症疗效的关键试验，DTBZ的QD和BID给药之间生物等效性的药代动力学数据，以及剂量比例证据，滴定建议，和DTBZER的安全配置文件。
■长期数据表明，DTBZ对TD和HD相关舞蹈病的治疗有效且耐受性良好。DTBZER可能证明治疗等效，没有新的安全信号。由于缺乏比较临床试验数据,关于最佳实践,没有关于选择VMAT2抑制剂或在VMAT2抑制剂之间切换的循证建议.最终,QD给药可能提供改善药物依从性的机会，复杂治疗方案患者和/或认知功能减退患者的重要考虑因素。
