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首页> 外文期刊>Clinical therapeutics >Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials.
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Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials.

机译：哌醋甲酯透皮系统对小儿注意力不足/多动症的长期耐受性：一项多中心，前瞻性，12个月，开放标签，不受控制的III期扩展的四项临床试验。

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BACKGROUND: Short-term treatment with the meth-ylphenidate transdermal system (MTS) has been well tolerated in several clinical trials in children with attention-deficit/hyperactivity disorder (ADHD). However, the effects of long-term use have not been systematically evaluated. OBJECTIVES: The primary objective of this study was to assess the 12-month tolerability of MTS in children with ADHD. Effectiveness was a secondary objective. METHODS: This Phase III study was a multicenter, 12-month, open-label, flexible-dose extension of 4 previous trials. In those studies, children aged 6 to 12 years with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria) received MTS, osmotic-release oral system methylphenidate, or placebo. At entry into the present study, the children either continued to receive their optimal dose of MTS (10, 15, 20, or 30 mg per 9-hour patch wear time) or underwent dose titration over 4 weeks to an optimal MTS dose, which was continued for the remainder of the study. Tolerability was evaluated based on adverse events (AEs), physical examinations, vital signs, electrocardiograms, laboratory tests, the Children's Sleep Habits Questionnaire, and the occurrence of application-site reactions. RESULTS: Of 327 enrolled subjects, 326 received treatment and 157 completed the study. The majority of enrolled subjects were male (64.8%) and white (73.7%), with a mean (SD) age of 9.2 (1.9) years. Two hundred sixty-five (81.3%) of the 326 subjects who received MTS reported AEs. AEs led to study discontinuation in 29 subjects (8.9%). The majority (98.3%) of treatment-emergent AEs were of mild or moderate severity. The most common AEs were decreased appetite (24.8%), headache (16.6%), upper respiratory tract infection (12.3%), cough (11.7%), pyrexia (10.1%), and decreased weight (10.1%). Of the 1118 AEs, 40.8% were considered possibly or probably related to study treatment. Three serious AEs (facial contusion, ankle fracture, and syncope) occurred and were considered unrelated to study treatment. Based on data collected across all study visits, application-site reactions generally consisted of mild erythema associated with mild discomfort at the patch site. Application-site reactions accounted for 22 (6.7%) study discontinuations. CONCLUSIONS: Slightly less than half (48.0%) of subjects completed this 12-month, open-label extension study of MTS. Most AEs were mild to moderate in severity and, with the exception of application-site reactions, were typical of those previously observed with methylphenidate. ClinicalTrials.gov identifier: NCT00151957.
机译：背景：在患有注意力缺陷/多动症（ADHD）的儿童中进行的几项临床试验中，对甲基苯哌丁酸透皮系统（MTS）的短期治疗耐受性良好。但是，长期使用的效果尚未得到系统的评估。目的：本研究的主要目的是评估多动症儿童对MTS的12个月耐受性。有效性是次要目标。方法：这项III期研究是一项多中心，为期12个月，开放标签，灵活剂量扩展的4项先前试验。在这些研究中，诊断为ADHD（精神障碍诊断和统计手册，第四版，文本修订标准）的6至12岁儿童接受了MTS，渗透释放的口服哌醋甲酯或安慰剂。在进入本研究时，儿童要么继续接受最佳剂量的MTS（每9小时贴片佩戴时间10、15、20或30毫克），要么在4周内进行剂量滴定至最佳MTS剂量，在其余的研究中继续进行。根据不良事件（AE），体格检查，生命体征，心电图，实验室检查，儿童睡眠习惯问卷以及应用现场反应的发生情况，评估耐受性。结果：在327名受试者中，有326名接受了治疗，其中157名完成了研究。入选的大多数受试者为男性（64.8％）和白人（73.7％），平均（SD）年龄为9.2（1.9）岁。接受MTS的326名受试者中有265名（81.3％）报告了AE。不良事件导致29名受试者（8.9％）的研究中断。大部分（98.3％）出现治疗的AE属于轻度或中度严重程度。最常见的AE是食欲下降（24.8％），头痛（16.6％），上呼吸道感染（12.3％），咳嗽（11.7％），发热（10.1％）和体重减轻（10.1％）。在1118例AE中，有40.8％被认为可能与研究治疗有关。发生了三种严重的不良事件（面部挫伤，踝部骨折和晕厥），被认为与研究治疗无关。根据所有研究访视收集的数据，应用部位反应通常包括轻度红斑和贴片部位轻度不适。应用现场反应占研究中断的22（6.7％）。结论：略少于一半（48.0％）的受试者完成了这项为期12个月的MTS开放标签扩展研究。大多数AE的严重程度为轻度至中度，除应用部位反应外，是以前使用哌醋甲酯观察到的典型事件。 ClinicalTrials.gov标识符：NCT00151957。

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