BACKGROUND & AIMS: OBJECTIVES:The purpose of this study was to assess long-term improvement in quality of life (QOL) in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with lisdexamfetamine dimesylate (LDX). METHODS:Adolescents with ADHD treated for ≥3 weeks in a 4 week, placebo-controlled study entered a 1 year, open-label study. After the 4 week dose optimization (30, 50, and 70 mg/day LDX) period, treatment was maintained for 48 additional weeks. Change from baseline (of prior study) to week 52/early termination (ET) (of open-label study) in ADHD Rating Scale IV (ADHD-RS-IV) assessed effectiveness, and the Youth QOL-Research Version (YQOL-R) assessed participant-perceived QOL. Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline (≥1 SD below the mean) versus all others, and for study completers versus study noncompleters. RESULTS:These post-hoc analyses included 265 participants. Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET. Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score. At week 52/ET, study completers had greater YQOL-R improvements than did noncompleters; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters. CONCLUSION:Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.

背景与目标： 目的：本研究的目的是评估使用赖氨苯丙胺二甲磺酸酯（LDX）治疗的患有注意力缺陷/多动症（ADHD）的青少年的生活质量（QOL）的长期改善。
方法：在4周的安慰剂对照研究中，接受ADHD治疗的青少年≥3周进入了为期1年的开放标签研究。经过4周的剂量优化（30、50和70μmg/天LDX /天）后，治疗又维持了48周。从ADHD评分量表IV（ADHD-RS-IV）评估的有效性和青年QOL研究版本（YQOL-R）从基线（先前研究）到第52周/（开放标签研究）提前终止（ET）的变化）评估参与者感知的QOL。事后分析描述了基线时自我感知的QOL差（均值低于1 SD）与所有其他参与者，研究完成者与研究未完成者的有效性和QOL。
结果：这些事后分析包括265名参与者。基线自我感觉较差的QOL（n = 32）与其他所有参与者（n = 232）的受试者在LDX上表现出强劲的YQOL-R感知得分变化（改善），在第28周时出现并维持至52 / ET周。基线自我感觉较差的QOL的参与者在52周/ ET的平均变化评分范围从9.8到17.6，其他所有参与者的平均变化得分在0.4到5.1之间；不管基线YQOL-R总得分如何，第52周/ ET在ADHD-RS-IV总得分中的改善都是相似的。在第52周/东部时间，研究完成者的YQOL-R改善比未完成者大。在52 / ET周，ADHD-RS-IV总成绩的变化也比未完成者大。
结论：与ADX青少年相比，LDX改善了参与者感知的QOL和ADHD症状；基线自我感觉较差的生活质量的参与者中最大的改善发生了。

BACKGROUND & AIMS: BACKGROUND:Despite the overall high degree of response to pharmacotherapy, consensus is lacking on how to judge clinical response or define optimal treatment/remission when treating adults with attention-deficit/hyperactivity disorder (ADHD). This study examined clinical response and symptomatic remission in analyses of 2 studies of lisdexamfetamine dimesylate (LDX) in adults with ADHD. METHODS:In a 4-week, double-blind, forced-dose trial, adults with ADHD were randomized to LDX 30, 50, and 70 mg/day (mg/d) or placebo. In a second, open-label, follow-up trial, adults entering from the 4-week study were titrated to an "optimal" LDX dose (30 mg/d [n=44], 50 mg/d [n=112], and 70 mg/d [n=171]) over 4 weeks, and maintained for 11 additional months. The ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts and the Clinical Global Impressions-Improvement (CGI-I) scale assessed efficacy. Clinical response was defined, post hoc, as ≥30% reduction from baseline in ADHD-RS-IV and CGI-I rating of 1 or 2; symptomatic remission was defined as ADHD-RS-IV total score ≤18. Log rank analysis examined overall significance among the treatment groups in time to response or remission. RESULTS:Four hundred and fourteen participants in the 4-week study and 345 in the open-label, extension study were included in the efficacy populations. All LDX groups improved by ADHD-RS-IV and CGI-I scores in both studies. In the 4-week study (n=414), 69.3% responded and 45.5% achieved remission with LDX (all doses); 37.1% responded and 16.1% achieved remission with placebo; time (95% CI) to median clinical response (all LDX doses) was 15.0 (15.0, 17.0) days and to remission was 31.0 (28.0, 37.0) days (P<.0001 overall). In the open-label study, with LDX (all doses), 313 (95.7%) and 278 (85.0%) of 327 participants with evaluable maintenance-phase data met criteria for response and remission, respectively. Of participants who completed dose optimization, 75.2% remained responders and 65.7% remained in remission in the 12-month study. Overall, 285 (82.6%) and 227 (65.8%) of 345 participants were responders and remitters, respectively, at their final visits. CONCLUSION:In the long-term study, with open-label, dose-optimized LDX treatment, most adults with ADHD achieved clinical response and/or symptomatic remission; almost two-thirds maintained symptomatic remission over the remaining 11 months. TRIAL REGISTRATION:Clinical Trial Numbers: NCT00334880 and NCT01070394CLINICAL TRIAL REGISTRY: clinicaltrials.gov.

背景与目标： 背景：尽管总体上对药物疗法的反应程度很高，但在治疗患有注意力不足/多动症（ADHD）的成人时如何判断临床反应或确定最佳治疗/缓解方面尚无共识。这项研究在2项多动症成人AD的赖氨苯丙胺二甲磺酸盐（LDX）的分析中检查了临床反应和症状缓解。
方法：在一项为期4周的双盲，强制剂量试验中，ADHD成人被随机分为LDX 30、50和70 mg / d（mg / d）或安慰剂。在第二项开放标签的后续试验中，将为期4周的研究的成年人调整为“最佳” LDX剂量（30 mg / d [n = 44]，50 mg / d [n = 112]）。和70毫克/天[n = 171]），持续4周，并再维持11个月。具有成人提示的ADHD评分量表IV（ADHD-RS-IV）和临床总体印象改善（CGI-I）量表评估了疗效。事后的临床反应定义为：ADHD-RS-IV和CGI-I分级为1或2较基线降低≥30％；症状缓解定义为ADHD-RS-IV总分≤18。对数秩分析及时检查了治疗组对应答或缓解的总体意义。
结果：4周研究中有414名参与者，开放标签扩展研究中有345名参与者被纳入疗效人群。在两项研究中，所有LDX组的ADHD-RS-IV和CGI-I得分均得到改善。在为期4周的研究中（n = 414），LDX（所有剂量）缓解率达69.3％，缓解率达45.5％。安慰剂缓解率为37.1％，缓解率为16.1％；中位临床反应（所有LDX剂量）的治疗时间（95％CI）为15.0（15.0，17.0）天，缓解时间为31.0（28.0，37.0）天（总体P <0.0001）。在开放标签研究中，采用LDX（所有剂量），在327位具有可评估的维持阶段数据的受试者中，分别有313名（95.7％）和278名（85.0％）达到了缓解和缓解的标准。在为期12个月的研究中，完成剂量优化的参与者中，仍有75.2％的患者有反应，而65.7％的患者仍处于缓解状态。总体上，在345位参与者中，有285位（82.6％）和227位（65.8％）在他们的最终访问中分别是响应者和缓解者。
结论：在长期研究中，通过开放标签，剂量优化的LDX治疗，大多数患有ADHD的成年人均达到了临床反应和/或症状缓解。在剩余的11个月中，几乎三分之二的患者保持了症状缓解。
试验注册：临床试验编号：NCT00334880和NCT01070394临床试验注册：clinicaltrials.gov。

BACKGROUND & AIMS: :Young adults with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be at increased risk for impairment in driving behaviors. While stimulant medications have proven efficacy in reducing ADHD symptomatology, there is limited knowledge as to their effects on driving impairment. The main aim of this study was to assess the impact of lisdexamfetamine dimesylate (LDX) on driving performance in young adults with ADHD using a validated driving simulation paradigm. This was a randomized, double-blind, 6-week, placebo-controlled, parallel-design study of LDX vs. a placebo on driving performance in a validated driving simulation paradigm. Subjects were sixty-one outpatients of both sexes, 18-26 years of age, who met DSM-IV criteria for ADHD. Subjects were randomized to receive LDX or placebo after a baseline driving simulation and completed a second driving simulation six weeks after beginning drug or placebo. Examination of reaction time across five surprise events at post-treatment showed a significant positive effect of medication status. LDX treatment was also associated with significantly fewer accidents vs. placebo. LDX treatment was associated with significantly faster reaction times and a lower rate of simulated driving collisions than placebo. These results suggest that LDX may reduce driving risks in young adults with ADHD.

背景与目标： ：患有注意力缺陷多动障碍（ADHD）的年轻人已显示出驾驶行为受损的风险增加。虽然兴奋剂已被证明能有效减少ADHD症状，但对其对驾驶障碍的影响知之甚少。这项研究的主要目的是使用经过验证的驾驶模拟范例来评估赖氨苯丙胺二甲磺酸酯（LDX）对ADHD年轻人的驾驶性能的影响。这是LDX与安慰剂在一项经过验证的驾驶模拟范例中进行的一项随机，双盲，为期6周，安慰剂对照，并行设计的研究。受试者为六十一名年龄在18-26岁之间的男女门诊患者，均符合DSM-IV的ADHD标准。在基线驾驶模拟后将受试者随机接受LDX或安慰剂，并在开始药物或安慰剂治疗六周后完成第二次驾驶模拟。治疗后五个意外事件中反应时间的检查显示出药物状态的显着积极影响。与安慰剂相比，LDX治疗还减少了事故。与安慰剂相比，LDX治疗与显着更快的反应时间和更低的模拟驾驶碰撞率相关。这些结果表明，LDX可以降低患有ADHD的年轻人的驾驶风险。

BACKGROUND & AIMS: :The purpose of this work was to assess the pharmacokinetics and safety of lisdexamfetamine dimesylate (LDX) delivered and released regionally in the gastrointestinal (GI) tract. In this open-label, randomized, crossover study, oral capsules and InteliSite delivery capsules containing LDX (50 mg) with radioactive marker were delivered to the proximal small bowel (PSB), distal SB (DSB), and ascending colon (AC) during separate periods. Gamma scintigraphy evaluated regional delivery and GI transit. LDX and d-amphetamine in blood were measured postdose (≤72 h). Treatment-emergent adverse events (TEAEs) were assessed. Healthy males (n = 18; 18-48 years) were enrolled. Mean (S.D.) maximal plasma concentration (C(max)) was 37.6 (4.54), 40.5 (4.95), 38.7 (6.46), and 25.7 (9.07) ng/ml; area under the concentration-time curve to the last measurable time point was 719.1 (157.05), 771.2 (152.88), 752.4 (163.38), and 574.3 (220.65) ng · h · ml⁻¹, respectively, for d-amphetamine after oral, PSB, DSB, and AC delivery of LDX. Median time to C(max) was 5, 4, 5, and 8 h, respectively. Most TEAEs were mild to moderate. No clinically meaningful changes were observed (laboratory, physical examination, or electrocardiogram). LDX oral administration or targeted delivery to small intestine had similar d-amphetamine systemic exposure, indicating good absorption, and had reduced absorption after colonic delivery. The safety profile was consistent with other LDX studies.

背景与目标： ：这项工作的目的是评估在胃肠道（GI）区域局部递送和释放的赖氨苯丙胺二甲磺酸酯（LDX）的药代动力学和安全性。在这项开放标签，随机，交叉研究中，口服胶囊和包含带有放射性标记物的LDX（50毫克）的InteliSite递送胶囊在治疗期间被递送至近端小肠（PSB），远端SB（DSB）和升结肠（AC）分开的时期。伽玛闪烁显像术评估了区域传递和胃肠道过境。用药后（≤72小时）测量血液中的LDX和d-苯异丙胺。评估治疗紧急不良事件（TEAE）。纳入健康男性（n = 18； 18-48岁）。平均（S.D.）最大血浆浓度（C（max））为37.6（4.54），40.5（4.95），38.7（6.46）和25.7（9.07）ng / ml;口服后d-苯异丙胺的浓度-时间曲线下到最后一个可测量时间点的面积分别为719.1（157.05），771.2（152.88），752.4（163.38）和574.3（220.65）ng·h·ml -1。 ，PSB，DSB和LDX的AC交付。 C（max）的中位时间分别为5、4、5和8 h。多数TEAE为轻度至中度。没有观察到具有临床意义的变化（实验室检查，体格检查或心电图检查）。口服LDX或靶向小肠给药具有相似的d-苯异丙胺全身暴露，表明其吸收良好，并且在结肠给药后吸收降低。安全性与其他LDX研究一致。

BACKGROUND & AIMS: :p38α mitogen-activated protein kinase (MAPK) is activated in cancer cells in response to environmental factors, oncogenic stress, radiation, and chemotherapy. p38α MAPK phosphorylates a number of substrates, including MAPKAP-K2 (MK2), and regulates the production of cytokines in the tumor microenvironment, such as TNF-α, interleukin-1β (IL-1β), IL-6, and CXCL8 (IL-8). p38α MAPK is highly expressed in human cancers and may play a role in tumor growth, invasion, metastasis, and drug resistance. LY2228820 dimesylate (hereafter LY2228820), a trisubstituted imidazole derivative, is a potent and selective, ATP-competitive inhibitor of the α- and β-isoforms of p38 MAPK in vitro (IC(50) = 5.3 and 3.2 nmol/L, respectively). In cell-based assays, LY2228820 potently and selectively inhibited phosphorylation of MK2 (Thr334) in anisomycin-stimulated HeLa cells (at 9.8 nmol/L by Western blot analysis) and anisomycin-induced mouse RAW264.7 macrophages (IC(50) = 35.3 nmol/L) with no changes in phosphorylation of p38α MAPK, JNK, ERK1/2, c-Jun, ATF2, or c-Myc ≤ 10 μmol/L. LY2228820 also reduced TNF-α secretion by lipopolysaccharide/IFN-γ-stimulated macrophages (IC(50) = 6.3 nmol/L). In mice transplanted with B16-F10 melanoma, tumor phospho-MK2 (p-MK2) was inhibited by LY2228820 in a dose-dependent manner [threshold effective dose (TED)(70) = 11.2 mg/kg]. Significant target inhibition (>40% reduction in p-MK2) was maintained for 4 to 8 hours following a single 10 mg/kg oral dose. LY2228820 produced significant tumor growth delay in multiple in vivo cancer models (melanoma, non-small cell lung cancer, ovarian, glioma, myeloma, breast). In summary, LY2228820 is a p38 MAPK inhibitor, which has been optimized for potency, selectivity, drug-like properties (such as oral bioavailability), and efficacy in animal models of human cancer.

背景与目标： ：p38α丝裂原激活蛋白激酶（MAPK）在癌细胞中被激活，以响应环境因素，致癌性应激，放射和化学疗法。 p38αMAPK磷酸化许多底物，包括MAPKAP-K2（MK2），并调节肿瘤微环境中细胞因子的产生，例如TNF-α，白介素-1β（IL-1β），IL-6和CXCL8（IL -8）。 p38αMAPK在人类癌症中高表达，并可能在肿瘤生长，侵袭，转移和耐药性中发挥作用。 LY2228820二甲磺酸酯（以下称LY2228820）是三取代的咪唑衍生物，是体外有效的p38 MAPKα和β亚型的ATP竞争性抑制剂（IC（50）分别为5.3和3.2 nmol / L） 。在基于细胞的分析中，LY2228820有效地和选择性地抑制了由茴香霉素刺激的HeLa细胞（蛋白印迹分析为9.8 nmol / L）和由茴香霉素诱导的小鼠RAW264.7巨噬细胞（IC（50）= 35.3）中MK2（Thr334）的磷酸化（nmol / L），但p38αMAPK，JNK，ERK1 / 2，c-Jun，ATF2或c-Myc≤10μmol/ L的磷酸化没有变化。 LY2228820还通过脂多糖/IFN-γ刺激的巨噬细胞（IC（50）= 6.3 nmol / L）减少了TNF-α的分泌。在移植有B16-F10黑色素瘤的小鼠中，LY2228820以剂量依赖性方式抑制肿瘤磷酸化MK2（p-MK2）[阈值有效剂量（TED）（70）= 11.2 mg / kg]。单次口服10 mg / kg剂量后，显着抑制靶标（p-MK2降低40％以上）。 LY2228820在多种体内癌症模型（黑色素瘤，非小细胞肺癌，卵巢癌，神经胶质瘤，骨髓瘤，乳腺癌）中产生了显着的肿瘤生长延迟。总之，LY2228820是一种p38 MAPK抑制剂，已针对人类癌症动物模型的效价，选择性，类药物特性（例如口服生物利用度）和功效进行了优化。

BACKGROUND & AIMS: BACKGROUND:There are few approved therapies for adults with attention-deficit/hyperactivity disorder (ADHD) in Europe. Lisdexamfetamine (LDX) is an effective treatment for ADHD; however, no clinical trials examining the efficacy of LDX specifically in European adults have been conducted. Therefore, to estimate the efficacy of LDX in European adults we performed a meta-regression of existing clinical data. METHODS:A systematic review identified US- and Europe-based randomized efficacy trials of LDX, atomoxetine (ATX), or osmotic-release oral system methylphenidate (OROS-MPH) in children/adolescents and adults. A meta-regression model was then fitted to the published/calculated effect sizes (Cohen's d) using medication, geographical location, and age group as predictors. The LDX effect size in European adults was extrapolated from the fitted model. Sensitivity analyses performed included using adult-only studies and adding studies with placebo designs other than a standard pill-placebo design. RESULTS:Twenty-two of 2832 identified articles met inclusion criteria. The model-estimated effect size of LDX for European adults was 1.070 (95% confidence interval: 0.738, 1.401), larger than the 0.8 threshold for large effect sizes. The overall model fit was adequate (80%) and stable in the sensitivity analyses. CONCLUSION:This model predicts that LDX may have a large treatment effect size in European adults with ADHD.

背景与目标： 背景：在欧洲，针对成人注意力不足/多动障碍（ADHD）的成人认可的疗法很少。 Lisdexamfetamine（LDX）是治疗ADHD的有效方法；但是，尚未进行过专门研究LDX在欧洲成人中的疗效的临床试验。因此，为了评估LDX在欧洲成人中的疗效，我们对现有临床数据进行了荟萃回归。
方法：系统评价确定了基于美国和欧洲的LDX，阿托西汀（ATX）或渗透释放口服哌醋甲酯（OROS-MPH）在儿童/青少年和成人中的随机疗效试验。然后使用药物，地理位置和年龄组作为预测因子，将荟萃回归模型拟合到已发布/计算出的效应量（Cohen d）。欧洲成年人的LDX效应大小是从拟合模型中推算出来的。进行的敏感性分析包括仅使用成人的研究，以及使用标准药丸-安慰剂设计以外的安慰剂设计进行的研究。
结果：2832篇已鉴定文章中有22篇符合纳入标准。欧洲成年人LDX的模型估计效应大小为1.070（95％置信区间：0.738、1.401），大于大效应大小的0.8阈值。总体模型拟合良好（80％），灵敏度分析稳定。
结论：该模型预测LDX在欧洲成人ADHD中可能具有较大的治疗效果。

BACKGROUND & AIMS: OBJECTIVE:This study examined the time course of efficacy-related endpoints for lisdexamfetamine dimesylate (LDX) versus placebo in adults with protocol-defined moderate to severe binge-eating disorder (BED). METHODS:In two 12-week, double-blind, placebo-controlled studies, adults meeting DSM-IV-TR BED criteria were randomized 1:1 to receive placebo or dose-optimized LDX (50 or 70 mg). Analyses across visits used mixed-effects models for repeated measures (binge eating days/week, binge eating episodes/week, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating [Y-BOCS-BE] scores, percentage body weight change) and chi-square tests (Clinical Global Impressions-Improvement [CGI-I; from the perspective of BED symptoms] scale dichotomized as improved or not improved). These analyses were not part of the prespecified testing strategy, so reported p values are nominal (unadjusted and descriptive only). RESULTS:Least squares mean treatment differences for change from baseline in both studies favored LDX over placebo (all nominal p values <  .001) starting at Week 1 for binge eating days/week, binge-eating episodes/week, and percentage weight change and at the first posttreatment assessment (Week 4) for Y-BOCS-BE total and domain scores. On the CGI-I, more participants on LDX than placebo were categorized as improved starting at Week 1 in both studies (both nominal p values <  .001). Across these efficacy-related endpoints, the superiority of LDX over placebo was maintained at each posttreatment assessment in both studies (all nominal p values <  .001). DISCUSSION:In adults with BED, LDX treatment appeared to be associated with improvement on efficacy measures as early as 1 week, which was maintained throughout the 12-week studies.

背景与目标： 目的：本研究探讨了方案定义为中度至重度暴饮暴食症（BED）的成年人中，赖氨酸安非他明二甲磺酸盐（LDX）与安慰剂的疗效相关终点的时程。
方法：在两项为期12周，双盲，安慰剂对照的研究中，将符合DSM-IV-TR BED标准的成年人按1：1随机接受安慰剂或剂量优化的LDX（50或70 mg）。两次访问之间的分析使用混合效果模型进行重复测量（暴饮暴食天/周，暴饮暴食发作/周，针对暴饮暴食[Y-BOCS-BE]评分修改的耶鲁-布朗强迫症量表，体重变化百分比）和平方检验（临床总体印象改善[CGI-I；从BED症状的角度看]分为改善或未改善的量表。这些分析不是预先指定的测试策略的一部分，因此报告的p值为标称值（未经调整且仅用于描述）。
结果：在两项研究中，偏方均值表示从基线开始改变的治疗差异（LDX优于安慰剂（所有标称p值均＜.001））始于第1周的暴饮暴食日/周，暴饮暴食发作/周，体重变化百分比和在第一次后处理评估（第4周）中获得Y-BOCS-BE总分和领域分数。在CGI-I上，两项研究中，从第1周开始，与安慰剂相比，更多的LDX参与者被归类为改善的（名义p值均<0.001）。跨越这些与功效相关的终点，在两项研究的每次治疗后评估中，LDX均优于安慰剂（所有标称p值均<0.001）。
讨论：在患有BED的成人中，LDX治疗似乎最早可在1周时改善疗效，并在整个12周的研究中一直保持这种状态。

BACKGROUND & AIMS: BACKGROUND:A 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED). METHODS:Adults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50- or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses. RESULTS:Of the 604 enrolled participants, 599 (521 women and 78 men) comprised the safety analysis set, and 369 completed the study. Mean (SD) LDX exposure was 284.3 (118.84) days; cumulative LDX exposure duration was 12 months or longer in 344 participants (57.4%). A total of 506 participants (84.5%) reported TEAEs (TEAEs leading to treatment discontinuation, 54 [9.0%]; severe TEAEs, 42 [7.0%]; serious TEAEs, 17 [2.8%]). Treatment-emergent adverse events reported in greater than or equal to 10% of participants were dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infection (11.4%). Mean (SD) changes from antecedent study baseline in systolic and diastolic blood pressure, pulse, and weight at week 52/early termination (n = 597) were 2.19 (11.043) and 1.77 (7.848) mm Hg, 6.58 (10.572) beats per minute, and -7.04 (7.534) kg, respectively. On the Columbia-Suicide Severity Rating Scale, there were 2 positive responses for any active suicidal ideations; there were no positive responses for suicidal behavior or completed suicides. CONCLUSIONS:In this 12-month, open-label, extension study, the long-term safety and tolerability of LDX in adults with BED were generally consistent with its established profile for attention-deficit/hyperactivity disorder.

背景与目标： 背景：一项为期12个月的开放标签扩展研究评估了成人暴食症（BED）的患者使用赖氨苯丙胺二甲酸酯（LDX）的长期安全性和耐受性。
方法：完成了三项前期研究之一的BED成人（18-55岁）参加了一项为期52周的开放标签扩展研究（剂量优化，为期4周[初始滴定剂量，30 mg LDX；目标剂量] ，50或70毫克LDX]；维持剂量48周。安全性评估包括紧急治疗不良事件（TEAE）的发生，生命体征和体重评估以及哥伦比亚－自杀严重性等级量表的反应。
结果：在604名参与者中，有599名（521名女性和78名男性）进行了安全性分析，其中369名完成了研究。平均（SD）LDX暴露时间为284.3（118.84）天； 344名参与者（57.4％）的累积LDX暴露持续时间为12个月或更长时间。共有506位参与者（84.5％）报告了TEAE（导致治疗中断的TEAE，占54 [9.0％]；严重的TEAE，占42 [7.0％]；严重的TEAE，占17 [2.8％]）。大于或等于10％的参与者报告的治疗紧急不良事件为口干（27.2％），头痛（13.2％），失眠（12.4％）和上呼吸道感染（11.4％）。在第52周/早期终止时（n = 597），收缩压和舒张压，脉搏和体重的平均（SD）变化为2.19（11.043）和1.77（7.848）mm Hg，每变化6.58（10.572）次分钟和-7.04（7.534）公斤。在《哥伦比亚自杀严重性等级量表》中，对任何积极的自杀观念有2个积极的回应。没有任何关于自杀行为或完全自杀的积极反应。
结论：在这项为期12个月的开放标签扩展研究中，LDX在BED成人中的长期安全性和耐受性通常与其针对注意力缺陷/多动障碍的既定特征相一致。

BACKGROUND & AIMS: :Lisdexamfetamine dimesylate is a novel prodrug approved in North America, Europe and Brazil for treating attention deficit hyperactivity disorder (ADHD). It undergoes rate-limited hydrolysis by red blood cells to yield d-amphetamine. Following our previous work comparing lisdexamfetamine with d-amphetamine, the neurochemical and behavioural profiles of lisdexamfetamine, methylphenidate and modafinil were compared by dual-probe microdialysis in the prefrontal cortex (PFC) and striatum of conscious rats with simultaneous locomotor activity measurement. We employed pharmacologically equivalent doses of all compounds and those that spanned the therapeutically relevant and psychostimulant range. Lisdexamfetamine (0.5, 1.5, 4.5 mg/kg d-amphetamine base, per os (po)), methylphenidate (3, 10, 30 mg/kg base, po) and modafinil (100, 300, 600 mg/kg base, po) increased efflux of dopamine and noradrenaline in PFC, and dopamine in striatum. Only lisdexamfetamine increased 5-hydroxytryptamine (5-HT) efflux in PFC and striatum. Lisdexamfetamine had larger and more sustained effects on catecholaminergic neurotransmission than methylphenidate or modafinil. Linear correlations were observed between striatal dopamine efflux and locomotor activity for lisdexamfetamine and methylphenidate, but not modafinil. Regression slopes revealed greater increases in extracellular dopamine could be elicited without producing locomotor activation by lisdexamfetamine than methylphenidate. These results are consistent with clinical findings showing that lisdexamfetamine is an effective ADHD medication with prolonged duration of action and good separation between its therapeutic actions and stimulant side-effects.

背景与目标： Lisdexamfetamine dimesylate是在北美，欧洲和巴西批准用于治疗注意力缺陷多动障碍（ADHD）的新型前药。它受到红细胞的限速水解，产生d-苯异丙胺。继我们之前的研究结果之后，通过双探针微透析在有意识大鼠的前额叶皮层（PFC）和纹状体中进行了同时运动功能的测量，比较了赖斯地非胺与d-苯异丙胺，赖斯地非胺，哌醋甲酯和莫达非尼的神经化学和行为特征。我们采用了所有化合物的药理等效剂量以及跨越治疗相关和精神兴奋剂范围的药物。 Lisdexamfetamine（0.5，1.5，4.5 mg / kg d-苯异丙胺碱，口服（po）），哌醋甲酯（3，10，30 mg / kg碱，口服）和莫达非尼（100，300，600 mg / kg碱，口服） ）PFC中多巴胺和去甲肾上腺素的流出量增加，纹状体中多巴胺的流出量增加。仅赖氨苯丙胺增加了PFC和纹状体中的5-羟色胺（5-HT）外排。 Lisdexamfetamine对儿茶酚胺能神经传递的作用大于哌醋甲酯或莫达非尼。观察到纹状体多巴胺外排与赖氨酸安非他明和哌醋甲酯的运动活性之间存在线性相关性，但莫达非尼则无此相关性。回归斜率显示，与哌醋甲酯相比，赖氨酸安非他明可引起更大的细胞外多巴胺增加而不会产生赖斯安非他明产生运动活化。这些结果与临床结果一致，该结果表明赖氨苯丙胺是一种有效的ADHD药物，具有延长的作用持续时间，并且在其治疗作用和刺激性副作用之间具有良好的分离性。

BACKGROUND & AIMS: INTRODUCTION:Lisdexamfetamine dimesylate (LDX) is a prodrug stimulant approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children 6-12 years of age. Parent surveys provide valuable information regarding the impact of ADHD treatments. METHODS:Parents of children with ADHD beginning treatment with LDX voluntarily completed surveys through an automated telephone system or the Internet before and 6 weeks after LDX treatment initiation. Prescribing physicians received individual reports of the responses for each survey completed by their patients' parents. All patients whose parents completed both baseline and 6 week surveys were included in the analyses. Subgroup analyses were conducted for those previously treated with medications to treat ADHD, including mixed amphetamine salts-extended release. RESULTS:LDX treatment was associated with a significant decrease in ADHD symptom interference with school activities, family interactions, homework, and social interactions (P<.01; N=11,576). Parents rated satisfaction with LDX as significantly higher than with their child's previous treatment (P<.01). On average, global improvement, tolerability, convenience, and satisfaction with LDX were all highly rated. CONCLUSION:Patients treated with LDX showed significant symptom improvement and parents reported significantly greater satisfaction than with prior treatment.

背景与目标： 简介：葡糖胺二甲酸酯（LDX）是一种前药兴奋剂，已批准用于治疗成人和6-12岁儿童的注意力缺陷/多动症（ADHD）。家长调查提供了有关多动症治疗影响的宝贵信息。
方法：开始接受LDX治疗的ADHD患儿的父母在开始LDX治疗之前和之后6周通过自动电话系统或互联网自愿完成调查。开处方的医生收到了患者父母完成的每次调查的个人报告。所有父母均完成基线和6周调查的患者均纳入分析。对以前用过ADHD药物治疗的患者进行了亚组分析，包括混合的苯丙胺盐延长释放。
结果：LDX治疗与ADHD症状显着减少有关，ADHD症状干扰学校活动，家庭互动，家庭作业和社交互动（P <.01； N = 11,576）。父母对LDX的满意程度明显高于对孩子先前的治疗（P <.01）。平均而言，对LDX的整体改进，耐受性，便利性和满意度均得到高度评价。
结论：接受LDX治疗的患者症状明显改善，父母报告的满意度明显高于先前治疗。

BACKGROUND & AIMS: :The present study aims to directly investigate the behavioral and antioxidant effects of simvastatin in a model of bipolar mania induced by lisdexamfetamine dimesylate. Wistar rats were treated for 30 days with simvastatin. On the 24th day after the start of treatment, each rat was administered lisdexamfetamine dimesylate for 7 days. The results suggest that simvastatin combined with lisdexamfetamine dimesylate induced a significant increased locomotion and lisdexamfetamine dimesylate administration causes an oxidative imbalance determined by an increment in lipid peroxidation, protein oxidation and alterations in the activities of antioxidant enzymes in brain areas; moreover, in the presence of simvastatin, most of these effects were prevented. These findings contribute to a better understanding of the critical roles of lisdexamfetamine dimesylate in the treatment of neuropsychiatric disorders, associated with increased oxidative stress and changes in antioxidant enzymatic defense. In view of the central role played by lisdexamfetamine dimesylate, the established antioxidant effect of simvastatin therapy is of major interest.

背景与目标： ：本研究旨在直接研究辛伐他汀在由来的右苯丙胺二甲磺酸酯诱导的双相性躁狂症模型中的行为和抗氧化作用。 Wistar大鼠用辛伐他汀治疗30天。在开始治疗后的第24天，向每只大鼠施用赖氨苯丙胺二甲磺酸盐7天。结果表明，辛伐他汀联合赖氨酸安非他明二甲磺酸酯引起明显的运动，而赖氨酸安非他明二甲磺酸酯的给药引起氧化失衡，这是由脂质过氧化，蛋白质氧化的增加以及脑区域抗氧化酶活性的改变所决定的。此外，在辛伐他汀的存在下，大多数这些作用被预防。这些发现有助于更好地理解赖氨苯丙胺二甲磺酸盐在神经精神疾病的治疗中的关键作用，该疾病与氧化应激增加和抗氧化酶防御能力的改变有关。考虑到赖氨苯丙胺二甲磺酸盐起的核心作用，辛伐他汀疗法已确立的抗氧化作用引起了人们的极大兴趣。

BACKGROUND & AIMS: BACKGROUND:Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). This analysis aimed to evaluate the impact of lisdexamfetamine dimesylate (LDX) on sleep quality in adults with ADHD. METHODS:This 4-week, phase 3, double-blind, forced-dose escalation study of adults aged 18 to 55 years with ADHD randomized participants to receive placebo (n = 62), or 30 (n = 119), 50 (n = 117), or 70 (n = 122) mg/d LDX, taken once a day in the morning. The self-rated Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at week 4 to assess sleep quality. The PSQI global score assesses 7 sleep components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) each scored from 0 (no difficulty) to 3 (severe difficulty). RESULTS:The mean baseline PSQI global score was 5.8 for LDX and 6.3 for placebo (P = .19) indicating poor overall sleep quality. At endpoint, least squares (LS) mean change from baseline was -0.8 for LDX vs -0.5 for placebo (P = .33). The daytime functioning component showed significant improvement in LS mean change at endpoint for LDX compared with placebo (LDX -0.4 vs placebo 0.0, P = .0001). LS mean changes for the other 6 PSQI components did not significantly differ from placebo. Sleep-related treatment-emergent adverse events with an incidence >/=2% in the active treatment and placebo groups, respectively, were insomnia (19.3% and 4.8%), initial insomnia (5.0% and 3.2%), middle insomnia (3.6% and 0%), sleep disorder (0.6% and 3.2%), somnolence (0.3% and 3.2%), and fatigue (4.7% and 4.8%), and were generally mild or moderate in severity. CONCLUSION:For most subjects, LDX was not associated with an overall worsening of sleep quality and significantly improved daytime functioning in adults with ADHD. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00334880.

背景与目标： 背景：睡眠障碍是成年人注意力不足/多动障碍（ADHD）的常见问题。这项分析旨在评估赖氨苯丙胺二甲磺酸盐（LDX）对多动症成人睡眠质量的影响。
方法：这项为期4周，第3期，双盲，强制剂量递增研究的对象为18至55岁的ADHD随机参与者，接受安慰剂（n = 62）或30（n = 119），50（n = 117）或70（n = 122）mg / d LDX，每天早晨服用一次。自我评估的匹兹堡睡眠质量指数（PSQI）在基线和第4周进行评估，以评估睡眠质量。 PSQI总体评分评估了7个睡眠成分（主观睡眠质量，睡眠潜伏期，睡眠时间，习惯性睡眠效率，睡眠障碍，睡眠药物的使用以及白天的功能障碍），其得分分别为0（无困难）至3（严重困难）。
结果：LDX的平均基线PSQI总体评分为5.8，安慰剂为6.3（P = 0.19），表明总体睡眠质量较差。在终点，LDX相对于基线的最小二乘法（LS）平均变化为-0.8，而安慰剂为-0.5（P = .33）。与安慰剂相比，白天功能成分显示LDX的LS终点平均均值显着改善（LDX -0.4 vs安慰剂0.0，P = .0001）。 LS均值表示其他6个PSQI成分的变化与安慰剂无显着差异。在积极治疗组和安慰剂组中，与睡眠有关的紧急治疗不良事件的发生率分别为> / = 2％，分别为失眠（19.3％和4.8％），初次失眠（5.0％和3.2％），中度失眠（3.6） ％和0％），睡眠障碍（0.6％和3.2％），嗜睡（0.3％和3.2％）和疲劳（4.7％和4.8％），严重程度一般为轻度或中度。
结论：对于大多数受试者，LDX与多动症成年人的睡眠质量总体恶化并没有明显改善白天的功能。
试验注册：clinicaltrials.gov标识符：NCT00334880。

BACKGROUND & AIMS: BACKGROUND:The efficacy, safety, and tolerability of lisdexamfetamine dimesylate (LDX) augmentation of antidepressant monotherapy in adults with major depressive disorder (MDD) from two phase 3 studies are reported. METHODS:Across study 1 (placebo, n=201; LDX, n=201) and study 2 (placebo, n=213; LDX, n=211), most participants (placebo and LDX) in the safety analysis set were female (study 1: 66.2% and 64.2%; study 2: 67.1% and 66.8%); mean±SD ages were 41.8±12.04 with placebo and 42.2±12.32 with LDX in study 1 and 42.6±11.41 with placebo and 42.0±11.63 with LDX in study 2. Participants (18-65 y) had DSM-IV-TR-diagnosed MDD and lead-in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores ≥24. Eight-week antidepressant lead-in phases prospectively assessed antidepressant response. Then, 8 weeks of randomized (1:1), double-blind treatment with dose-optimized LDX (20-70mg) or placebo in participants exhibiting inadequate antidepressant monotherapy responses (augmentation baseline MADRS total scores ≥18 and <50% MADRS total score reductions from lead-in baseline to augmentation baseline) was initiated. The primary endpoint was MADRS total score change from augmentation baseline to week 16. Safety and tolerability measures included the occurrence of treatment-emergent adverse events (TEAEs). RESULTS:Least squares mean (95% CI) treatment differences (LDX-placebo) for MADRS total score changes from augmentation baseline to week 16 were not statistically significant in study 1 (0.1 [-1.7, 2.0], P=0.883) or study 2 (-0.5 [-2.3, 1.3], P=0.583). The only TEAE reported by >5% of LDX participants at twice the placebo rate in both studies was dry mouth. LIMITATIONS:Limitations include the exclusion of participants with psychiatric comorbidities/active medical disorders, the inability to assess specific MDD symptom domains (eg, anhedonia, cognition) or subtypes, the use of telephone-based depression assessments, and the potential influence of placebo response. CONCLUSION:Contrary to expectations, LDX augmentation was not superior to placebo in reducing depressive symptoms in individuals with MDD exhibiting inadequate responses to antidepressant monotherapy.

背景与目标： 背景：从两项3期研究中报告了赖斯地非米他明二甲磺酸酯（LDX）增强抗抑郁药单一疗法在成人重度抑郁症（MDD）中的疗效，安全性和耐受性。
方法：在研究1（安慰剂，n = 201; LDX，n = 201）和研究2（安慰剂，n = 213; LDX，n = 211）中，安全性分析集中的大多数参与者（安慰剂和LDX）是女性（研究1：66.2％和64.2％；研究2：67.1％和66.8％）；在研究1中，安慰剂组的平均±SD年龄为41.8±12.04，在LDX中为42.2±12.32，在安慰剂组中为42.6±11.41，在LDX中为42.0±11.63。研究对象（18-65岁）的DSM-IV-TR诊断为MDD和导入的基线蒙哥马利-奥斯伯格抑郁量表（MADRS）总分≥24。八周的抗抑郁药导入期前瞻性评估了抗抑郁药的反应。然后，对表现出抗抑郁单一疗法反应不足的参与者（增强基线MADRS总分≥18，MADRS总分<50％）进行随机化（1：1），剂量优化的LDX（20-70mg）或安慰剂双盲治疗8周从导入基准减少到增强基准）。主要终点是从增强基线到第16周的MADRS总得分变化。安全性和耐受性措施包括治疗紧急不良事件（TEAE）的发生。
结果：在研究1（0.1 [-1.7，2.0]，P = 0.883）或研究中，从增强基线到第16周的MADRS总评分变化的最小二乘均值（95％CI）治疗差异（LDX-安慰剂）没有统计学意义。 2（-0.5 [-2.3，1.3]，P = 0.583）。在两项研究中，超过5％的LDX参与者报告的安慰剂发生率是5％的唯一TEAE是口干。
局限性：限制包括排除患有精神病合并症/活动性疾病，无法评估特定MDD症状域（例如，快感，认知）或亚型的参与者，使用基于电话的抑郁症评估以及安慰剂反应的潜在影响。
结论：与预期相反，在MDD对抗抑郁单一疗法反应不足的个体中，LDX增强在减轻抑郁症状方面不优于安慰剂。

BACKGROUND & AIMS: BACKGROUND:Efficacy and safety profiles by sex and age (6-9 vs 10-12 years) and magnitude and duration of effect by effect size overall and across the day of lisdexamfetamine dimesylate (LDX) vs placebo were assessed. METHODS:This study enrolled children (6-12 years) with attention-deficit/hyperactivity disorder (ADHD) in an open-label dose optimization with LDX (30-70 mg/d) followed by a randomized, double-blind, placebo-controlled, 2-way crossover phase. Post hoc analyses assessed interaction between sex or age and treatment and assessed effect sizes for Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and Permanent Product Measure of Performance (PERMP) scales and ADHD Rating Scale IV measures. No corrections for multiple testing were applied on time points and subgroup statistical comparisons. RESULTS:129 participants enrolled; 117 randomized. Both sexes showed improvement on all assessments at postdose time points; females showed less impairment than males for SKAMP and PERMP scores in treatment and placebo groups at nearly all times. Both age groups improved on all assessments at postdose time points. Children 10-12 years had less impairment in SKAMP ratings than those 6-9 years. Treatment-by-sex interactions were observed at time points for SKAMP-D, SKAMP total, and PERMP scores; no consistent pattern across scales or time points was observed. LDX demonstrated significant improvement vs placebo, by effect size, on SKAMP-D from 1.5-13 hours postdose. The overall LS mean (SE) SKAMP-D effect size was -1.73 (0.18). In the dose-optimization phase, common (≥2%) treatment-emergent adverse events (TEAEs) in males were upper abdominal pain, headache, affect lability, initial insomnia, and insomnia; in females were nausea and decreased weight. During the crossover phase for those taking LDX, higher incidence (≥2% greater) was observed in males for upper abdominal pain and insomnia and in females for nausea and headache. Overall incidence of TEAEs in age groups was similar. CONCLUSION:Apparent differences in impairment level between sex and age groups were noted. However, these results support the efficacy of LDX from 1.5 hours to 13 hours postdose in boys and girls with medium to large effect sizes across the day with some variability in TEAE incidence by sex. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT00500149.

背景与目标： 背景：评估了按性别和年龄（6-9岁vs 10-12岁）的疗效和安全性概况，以及总体上以及整个疗程中赖氨酸安非他明二甲磺酸盐（LDX）与安慰剂的影响大小和作用持续时间。
方法：本研究招募了患有注意缺陷/多动障碍（ADHD）的儿童（6-12岁），采用LDX（30-70 mg / d）的开放标签剂量优化，然后进行随机，双盲，安慰剂治疗。受控的2路交叉相位。事后分析评估了性别或年龄与治疗之间的相互作用，并评估了Swanson，Kotkin，Agler，M-Flynn和Pelham（SKAMP）的效果大小以及性能永久性产品量度（PERMP）量表和ADHD评分量表IV。没有对时间点和亚组统计比较进行多次测试的更正。
结果：129名研究对象参加了该研究。 117个随机分组。服药后两个时间点，男女双方的所有评估均表现出改善；在治疗和安慰剂组中，女性几乎没有出现SKAMP和PERMP评分方面的障碍。在给药后的时间点，所有年龄组的所有评估均得到改善。 10至12岁的儿童对SKAMP评分的损害程度低于6至9岁的儿童。在时间点观察到按性别的治疗交互作用，包括SKAMP-D，SKAMP总分和PERMP得分。没有观察到跨越尺度或时间点的一致模式。从给药后的大小来看，LDX在给药后1.5-13小时内对安慰剂具有显着改善，与安慰剂相比有所改善。总体LS均值（SE）SKAMP-D效应量为-1.73（0.18）。在剂量优化阶段，男性常见的（≥2％）治疗紧急不良事件（TEAE）是上腹痛，头痛，影响不稳定性，最初的失眠和失眠。女性恶心和体重减轻。在服用LDX的人群的交叉阶段，男性上腹部疼痛和失眠的发生率更高（≥2％），女性恶心和头痛的发生率更高。年龄组中TEAE的总体发生率相似。
结论：注意到性别和年龄组之间的损伤水平的明显差异。但是，这些结果支持了服药后1.5小时至13小时的LDX在全天中到大型效应的男孩和女孩，其TEAE发病率随性别存在一定差异。
试验注册号：ClinicalTrials.gov标识符：NCT00500149。

BACKGROUND & AIMS: OBJECTIVE:To review the pharmacology, pharmacokinetics, efficacy, and safety of the prodrug lisdexamfetamine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults and describe its potential place in therapy. DATA SOURCES:Primary literature published between January 1, 1990, and August 1, 2008, was selected from PubMed using the search key words lisdexamfetamine, Vyvanse, and NRP104. References of selected publications were also reviewed. Posters and abstracts of research presented at national meetings were reviewed when available. The product labeling for Vyvanse was also used. STUDY SELECTION AND DATA EXTRACTION:Preference was given to published, randomized, and controlled research describing the pharmacokinetics, efficacy, and safety of lisdexamfetamine. Noncontrolled studies, postmarketing reports, and poster presentations were considered secondly. All published studies were included. DATA SYNTHESIS:Lisdexamfetamine is a prodrug of dextroamphetamine covalently bound to l-lysine, which is activated during first-pass metabolism. The unique pharmacokinetic profile owing to lisdexamfetamine's prodrug design and rate-limited enzymatic biotransformation allows for once-daily dosing with a duration of activity of approximately 12 hours. Lisdexamfetamine has been proven to reduce the symptoms of ADHD both in children aged 6-12 years and adults aged 18-55 years, decreasing ADHD rating scale scores by approximately 27 and 19 points, respectively. Adverse effects with an incidence greater than 10% during preclinical trials included appetite suppression, insomnia, and headache. Lisdexamfetamine's unique pharmacokinetic properties may provide additional safety with regard to reducing abuse potential. As with other central nervous system (CNS) stimulants, concerns regarding sudden cardiac death and adverse effects on growth also apply to lisdexamfetamine. CONCLUSIONS:Lisdexamfetamine provides another amphetamine-based CNS stimulant option for treatment of children and adults with ADHD. However, its use may be limited by a lack of significant differentiation when compared with currently used stimulants and a lack of evidence to support its use in adolescents.

背景与目标： 目的：探讨前体药物赖斯地非胺的药理学，药代动力学，疗效和安全性，用于治疗儿童和成人的注意力缺陷/多动障碍（ADHD），并描述其在治疗中的潜在地位。
数据来源：1990年1月1日至2008年8月1日之间发布的主要文献是使用搜索词lisdexamfetamine，Vyvanse和NRP104从PubMed中选择的。还对选定出版物的参考文献进行了审查。如有可能，对在国家会议上发表的研究海报和摘要进行审查。还使用了Vyvanse的产品标签。
研究选择和数据提取：优先选择已公开，随机和对照的研究，这些研究描述了赖氨苯丙胺的药代动力学，功效和安全性。其次考虑了非对照研究，上市后报告和海报展示。所有已发表的研究都包括在内。
数据合成：右旋苯丙胺是右旋苯丙胺的前药，与右旋赖氨酸共价结合，在首过代谢中被激活。由于赖氨苯丙胺的前药设计和速率受限的酶促生物转化而产生的独特药代动力学特征允许每天一次给药，持续时间约12小时。事实证明，葡糖胺可以减轻6-12岁儿童和18-55岁成年人的ADHD症状，使ADHD评分量表的得分分别降低约27和19分。临床前试验中发生率大于10％的不良反应包括食欲不振，失眠和头痛。 Lisdexamfetamine独特的药代动力学特性可以在减少滥用可能性方面提供额外的安全性。与其他中枢神经系统（CNS）刺激剂一样，赖斯美沙酮也涉及心脏猝死和对生长的不利影响。
结论：葡糖胺能提供另一种基于苯丙胺的中枢神经系统兴奋剂，用于治疗多动症儿童和成人。但是，与目前使用的兴奋剂相比，它的使用可能会受到限制，因为缺乏明显的区别，并且缺乏支持其在青少年中使用的证据。