Efficacy and safety of guanfacine extended-release in Japanese adults with attention-deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study.
Efficacy and safety of guanfacine extended-release in Japanese adults with attention-deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study.
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DOI：
10.1002/npr2.12152
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发表时间：
2021-03
影响因子：
2.5
通讯作者：
Iwanami A
中科院分区：
文献类型：
--
作者：
Naya N;Sakai C;Okutsu D;Kiguchi R;Fujiwara M;Tsuji T;Iwanami A
此前，我们通过一项3期双盲、安慰剂对照的随机试验，报道了胍法辛缓释剂(GXR)对患有注意力缺陷/多动障碍(ADHD)的日本成年人的疗效和安全性。在这项探索性的事后分析中，我们评估了以下亚型的GXR的有效性和/或安全性：注意缺陷多动障碍合并(ADHD-C)和主要注意力不集中(ADHD-I)亚型，年龄(≥31岁，31岁)，性别(男性，女性)和体重(≥50，50公斤)。主要疗效终点是第10周时日本版ADHD-Rating Scale-IV(ADHD-RS-IV)和成人提示(总分)基线的变化。疗效分析人群包括200名患者(GXR，100名；安慰剂，100名)。所有亚组(总人口：0.52，ADHD-C：0.51，ADHD-I：0.52，≥31年：0.61年，31年：0.47，男性：0.50，女性：0.57)ADHD-RS-IV总分效应大小(GXR与安慰剂相比)相似。在各亚组之间，紧急治疗不良事件(TEAE)的发生率/类型没有重大差异。显著的TEAEs(34.3%，10.6%)和导致停用的TEAEs(34.3%，12.1%)在女性中的发生率分别约为男性的三倍。在剂量优化期间，体重为50 mg/kg和50 mg/kg≥患者的TEAEs发生率分别为100%和73.6%，在维持期分别为40%和24.4%。对成人ADHD患者进行的这项特别分析的结果支持GXR的有效性和安全性，无论ADHD亚型、年龄或性别，并建议根据需要对所有患者仔细监测TEAE和GXR剂量优化。在这项探索性的事后分析中，我们评估了以下亚型：注意力缺陷/多动障碍亚型(注意力缺陷/多动障碍合并，主要是注意力不集中)、年龄(≥，31岁)、性别(男性，女性)和体重(<；50 kg，≥50 kg)的疗效和/或安全性。在成人提示下，ADHD评定量表-IV在所有亚组中的总分效果大小(GXR与安慰剂在10周时)相似。这一发现支持了GXR在成人中的有效性和安全性，无论ADHD亚型、年龄或性别，并建议根据需要对所有患者仔细监测TEAE和GXR剂量优化。
Previously, we reported on the efficacy and safety of guanfacine extended‐release (GXR) in Japanese adults with attention‐deficit/hyperactivity disorder (ADHD) from a phase 3, double‐blind, placebo‐controlled, randomized trial. In this exploratory post hoc analysis, we assessed the efficacy and/or safety of GXR in the following subgroups: ADHD‐combined (ADHD‐C) and ADHD‐predominantly inattentive (ADHD‐I) subtypes, age (≥31, <31 years), sex (male, female), and body weight (≥50, <50 kg). The primary efficacy endpoint was change from baseline in the Japanese version of the investigator‐rated ADHD‐Rating Scale‐IV (ADHD‐RS‐IV) with adult prompts (total scores) at week 10. The efficacy analysis population included 200 patients (GXR, 100; placebo, 100). ADHD‐RS‐IV total score effect sizes (GXR vs placebo) were similar across all subgroups (total population: 0.52, ADHD‐C: 0.51, ADHD‐I: 0.52, ≥31 years: 0.61, <31 years: 0.47, male: 0.50, female: 0.57). There were no major differences in the incidence/types of treatment‐emergent adverse events (TEAEs) across the subgroups. The incidence of significant TEAEs (34.3%, 10.6%) and TEAEs leading to discontinuation (34.3%, 12.1%) were approximately three times higher in females than males, respectively. The incidence of TEAEs in patients weighing <50 kg and ≥50 kg was 100% and 73.6% during dose optimization and 40% and 24.4% during the maintenance period, respectively. Findings from this post hoc analysis in adults with ADHD support the efficacy and safety of GXR regardless of ADHD subtype, age, or sex and suggest that careful monitoring for TEAEs and GXR dose optimization is considered for all patients, as needed. In this exploratory post hoc analysis, we assessed the efficacy and/or safety of guanfacine extended release (GXR) in the following subgroups: attention‐deficit/hyperactivity disorder (ADHD) subtypes (ADHD‐combined, ADHD‐predominantly inattentive), age (≥31 years, <31 years), sex (male, female), and body weight (<50 kg, ≥50 kg). ADHD‐Rating Scale‐IV with adult prompts total score effect sizes (GXR vs placebo at 10 weeks) were similar across all subgroups. The findings support the efficacy and safety of GXR in adults regardless of ADHD subtype, age, or sex and suggest that careful monitoring for TEAEs and GXR dose optimization is considered for all patients, as needed.
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DOI：
10.1016/j.jaac.2015.08.016
发表时间：
2015-11-01
影响因子：
13.3
作者：
Wilens, Timothy E.;Robertson, Brigitte;Cutler, Andrew J.
通讯作者：
Cutler, Andrew J.
影响因子：
6.9
作者：
Able, Stephen L.;Johnston, Joseph A.;Swindle, Ralph W.
通讯作者：
Swindle, Ralph W.
DOI：
10.5414/cp202065
发表时间：
2015-04-01
影响因子：
0.8
作者：
Martin, Patrick;Satin, Lawrence;Ermer, James C.
通讯作者：
Ermer, James C.
影响因子：
1.9
作者：
Sallee, Floyd R.;Kollins, Scott H.;Wigal, Timothy L.
通讯作者：
Wigal, Timothy L.
DOI：
10.1007/s12402-016-0208-3
发表时间：
2017-03
期刊：
Attention deficit and hyperactivity disorders
影响因子：
--
作者：
Fayyad J;Sampson NA;Hwang I;Adamowski T;Aguilar-Gaxiola S;Al-Hamzawi A;Andrade LH;Borges G;de Girolamo G;Florescu S;Gureje O;Haro JM;Hu C;Karam EG;Lee S;Navarro-Mateu F;O'Neill S;Pennell BE;Piazza M;Posada-Villa J;Ten Have M;Torres Y;Xavier M;Zaslavsky AM;Kessler RC;WHO World Mental Health Survey Collaborators
通讯作者：
WHO World Mental Health Survey Collaborators