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.

译文

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。

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