Häge A, Banaschewski T, Dittmann R W
Fortschr Neurol Psychiatr. 2015 Dec;83(12):676-85. doi: 10.1055/s-0041-110441. Epub 2015 Dec 29.
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder - which may persist into adolescence and adulthood. Psychostimulants and atomoxetine (ATX) are frequently prescribed to treat ADHD in Germany. Lisdexamfetamine dimesylate (LDX) is the most recently approved ADHD medication in Germany and other European countries. Data used to support the European registration of LDX is summarised from three phase-3/3b studies in children and adolescents with ADHD. Short-term efficacy (study SPD489 - 325), maintenance of efficacy (study SPD489 - 326) and efficacy in patients who had previously responded inadequately to methylphenidate (MPH) treatment (study SPD489 - 317) were demonstrated. The safety and tolerability profile of LDX in all three European studies was shown to be in line with that of other psychostimulants used to treat patients with ADHD.
注意力缺陷多动障碍(ADHD)是一种神经发育障碍,可能会持续到青少年期和成年期。在德国,精神兴奋剂和托莫西汀(ATX)常用于治疗ADHD。二甲磺酸赖右苯丙胺(LDX)是德国和其他欧洲国家最近批准用于治疗ADHD的药物。用于支持LDX在欧洲注册的数据来自三项针对ADHD儿童和青少年的3期/3b期研究。研究证明了其短期疗效(SPD489-325研究)、疗效维持(SPD489-326研究)以及在先前对哌甲酯(MPH)治疗反应不佳的患者中的疗效(SPD489-317研究)。在所有三项欧洲研究中,LDX的安全性和耐受性与用于治疗ADHD患者的其他精神兴奋剂一致。