Efficacy of Guanfacine Extended Release in the Treatment of Combined and Inattentive Only Subtypes of Attention-Deficit/Hyperactivity Disorder
Efficacy of Guanfacine Extended Release in the Treatment of Combined and Inattentive Only Subtypes of Attention-Deficit/Hyperactivity Disorder
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DOI：
10.1089/cap.2010.0135
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发表时间：
2012-06-01
影响因子：
1.9
通讯作者：
Wigal, Timothy L.
中科院分区：
文献类型：
--
作者：
Sallee, Floyd R.;Kollins, Scott H.;Wigal, Timothy L.
背景：缓释胍(GXR)被批准用于治疗6-17岁儿童和青少年的注意缺陷/多动障碍(ADHD)。这项事后分析进一步考察了GXR对多动症--冲动和注意力不集中--的影响。方法：对GXR治疗ADHD的两个大型双盲安慰剂对照关键试验的数据进行分析。利用汇集的人群提供足够的样本量和相关的统计能力，通过比较GXR组和安慰剂组与ADHD三个亚型中的每一组的ADHD评定量表IV(ADHD-RS-IV)总分，检查GXR治疗对核心ADHD症状的影响。随机剂量组(与安慰剂组相比)总体研究人群的ADHD-RS-IV多动-冲动和注意力不集中子量表评分也被检测。结果：完整的分析集包括631名6-17岁的受试者(GXR：490例；安慰剂：141例)。在以注意力不集中为主的ADHD亚型受试者中，在治疗3周至5周和治疗结束时，服用GXR的受试者(n=127)ADHD-RS-IV总分的最小二乘(LS)平均降幅显著大于安慰剂组(n=38)(p
Background: Extended-release guanfacine (GXR) is approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years. This post-hoc analysis further examines the effects of GXR on hyperactivity-impulsivity and inattentiveness. Method: Data from two large double-blind placebo-controlled pivotal trials of GXR in the treatment of ADHD were analyzed. Using the pooled population to provide sufficient sample size and associated statistical power, the impact of GXR treatment on core ADHD symptoms was examined by comparing ADHD Rating Scale IV (ADHD-RS-IV) total scores in the overall GXR and placebo groups in subjects with each of the three ADHD subtypes. ADHD-RS-IV Hyperactivity-Impulsivity and Inattentiveness subscale scores in the overall study population by randomized dose group (vs. placebo) were also examined. Results: The full analysis set included 631 subjects aged 6-17 years (GXR: n = 490; placebo: n = 141). Among subjects with the predominantly inattentive subtype of ADHD, differences in least squares (LS) mean reductions from baseline in ADHD-RS-IV total scores were significantly greater in GXR-treated subjects (n = 127) than in placebo-treated subjects (n = 38) at treatment weeks 3 through 5 and end point (p