OBJECTIVE:To review the pharmacology, pharmacokinetics, efficacy, and safety of the prodrug lisdexamfetamine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults and describe its potential place in therapy. DATA SOURCES:Primary literature published between January 1, 1990, and August 1, 2008, was selected from PubMed using the search key words lisdexamfetamine, Vyvanse, and NRP104. References of selected publications were also reviewed. Posters and abstracts of research presented at national meetings were reviewed when available. The product labeling for Vyvanse was also used. STUDY SELECTION AND DATA EXTRACTION:Preference was given to published, randomized, and controlled research describing the pharmacokinetics, efficacy, and safety of lisdexamfetamine. Noncontrolled studies, postmarketing reports, and poster presentations were considered secondly. All published studies were included. DATA SYNTHESIS:Lisdexamfetamine is a prodrug of dextroamphetamine covalently bound to l-lysine, which is activated during first-pass metabolism. The unique pharmacokinetic profile owing to lisdexamfetamine's prodrug design and rate-limited enzymatic biotransformation allows for once-daily dosing with a duration of activity of approximately 12 hours. Lisdexamfetamine has been proven to reduce the symptoms of ADHD both in children aged 6-12 years and adults aged 18-55 years, decreasing ADHD rating scale scores by approximately 27 and 19 points, respectively. Adverse effects with an incidence greater than 10% during preclinical trials included appetite suppression, insomnia, and headache. Lisdexamfetamine's unique pharmacokinetic properties may provide additional safety with regard to reducing abuse potential. As with other central nervous system (CNS) stimulants, concerns regarding sudden cardiac death and adverse effects on growth also apply to lisdexamfetamine. CONCLUSIONS:Lisdexamfetamine provides another amphetamine-based CNS stimulant option for treatment of children and adults with ADHD. However, its use may be limited by a lack of significant differentiation when compared with currently used stimulants and a lack of evidence to support its use in adolescents.

译文

目的:探讨前体药物赖斯地非胺的药理学,药代动力学,疗效和安全性,用于治疗儿童和成人的注意力缺陷/多动障碍(ADHD),并描述其在治疗中的潜在地位。
数据来源:1990年1月1日至2008年8月1日之间发布的主要文献是使用搜索词lisdexamfetamine,Vyvanse和NRP104从PubMed中选择的。还对选定出版物的参考文献进行了审查。如有可能,对在国家会议上发表的研究海报和摘要进行审查。还使用了Vyvanse的产品标签。
研究选择和数据提取:优先选择已公开,随机和对照的研究,这些研究描述了赖氨苯丙胺的药代动力学,功效和安全性。其次考虑了非对照研究,上市后报告和海报展示。所有已发表的研究都包括在内。
数据合成:右旋苯丙胺是右旋苯丙胺的前药,与右旋赖氨酸共价结合,在首过代谢中被激活。由于赖氨苯丙胺的前药设计和速率受限的酶促生物转化而产生的独特药代动力学特征允许每天一次给药,持续时间约12小时。事实证明,葡糖胺可以减轻6-12岁儿童和18-55岁成年人的ADHD症状,使ADHD评分量表的得分分别降低约27和19分。临床前试验中发生率大于10%的不良反应包括食欲不振,失眠和头痛。 Lisdexamfetamine独特的药代动力学特性可以在减少滥用可能性方面提供额外的安全性。与其他中枢神经系统(CNS)刺激剂一样,赖斯美沙酮也涉及心脏猝死和对生长的不利影响。
结论:葡糖胺能提供另一种基于苯丙胺的中枢神经系统兴奋剂,用于治疗多动症儿童和成人。但是,与目前使用的兴奋剂相比,它的使用可能会受到限制,因为缺乏明显的区别,并且缺乏支持其在青少年中使用的证据。

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