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Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD

机译：与ADHD的儿童和青少年的关羽延长释放的长期安全性和疗效

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Data are reported from SPD503-318, a phase 3, open-label, safety study of guanfacine extended release (GXR) in European children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Participants received dose-optimized GXR (1-7mg/day) for up to 2years. Of 215 enrolled participants, 214 were included in the safety population and 133 completed the study. Participants' mean age was 11.7years and 73.8% were male. Overall, 177 participants (82.7%) experienced a treatment-emergent adverse event (TEAE). TEAEs reported in at least 10% of participants were somnolence (36.0%), headache (28.5%), fatigue (20.1%), and nasopharyngitis (11.7%). Serious TEAEs were reported in 4.7% of participants and TEAEs leading to discontinuation were reported in 3.3% of participants. There were no deaths. Mean z-scores for BMI were stable throughout the study. The incidence of sedative TEAEs (somnolence, sedation, and hypersomnia) peaked during week 3 and decreased thereafter. Small changes from baseline to the final assessment in mean supine pulse [-5.5 bpm (standard deviation, 12.98)] and blood pressure [systolic, 0.6 mmHg (9.32); diastolic, 0.2 mmHg (9.17)] were reported. ADHD symptoms initially decreased and remained significantly lower than baseline at study endpoint. At the final assessment, the mean change in ADHD-RS-IV total score from baseline was -19.8 (standard error of mean, 0.84; nominal p0.0001). In conclusion, GXR was well tolerated and more than 60% of participants completed the 2-year study.
机译：从SPD503-318，欧洲儿童和青少年（ADHD）中的欧洲儿童和青少年（ADHD）中的欧洲儿童和青少年（ADHD）的青少年延长释放（GXR）的第3阶段，开放式标签，安全性研究报告。参与者接受了多达2年的剂量优化的GXR（1-7毫克/天）。在215名入门参与者中，214名纳入安全人口，133人完成了这项研究。参与者的平均年龄是11.7年，73.8％是男性。总体而言，177名参与者（82.7％）经历了一种治疗紧急的不良事件（茶）。在至少10％的参与者中报告的茶是嗜睡（36.0％），头痛（28.5％），疲劳（20.1％）和鼻咽炎（11.7％）。报告了4.7％的参与者和茶叶中报告了严重的茶叶，以3.3％的参与者报告。没有死亡。平均BMI的Z分数在整个研究中都稳定。在第3周期间达到镇静茶（嗜睡，镇静和疼痛）的发病率，此后减少。从基线到最终评估的小变化在仰卧脉冲中的最终评估[-5.5 bpm（标准偏差，12.98）]和血压[收缩，0.6mmHg（9.32）;报道了舒张，0.2mmHg（9.17）]。 ADHD症状最初下降，并且在研究终点上显着低于基线。在最终评估中，基线的ADHD-RS-IV总分的平均变化为-19.8（平均值的标准误差为0.84;标称P＆ 0.0001）。总之，GXR耐受良好，60多名参与者完成了2年的研究。

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