Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, PO Box 980710, Richmond, VA 23298-0710.
Department of Psychiatry and Institute for Women's Health, Virginia Commonwealth University, Richmond, Virginia, USA.
J Clin Psychiatry. 2019 Feb 26;80(2):18m12378. doi: 10.4088/JCP.18m12378.
To describe clinical characteristics and lisdexamfetamine dimesylate (LDX) treatment effects, based on gender and age, in adults diagnosed with moderate to severe binge eating disorder (BED).
Adults diagnosed with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision-defined BED of moderate to severe severity were randomized to 12 weeks of dose-optimized LDX (50 or 70 mg) or placebo in 2 studies (conducted from November 26, 2012, to September 25, 2013 [study 1] and from November 26, 2012, to September 20, 2013 [study 2]). These post hoc analyses pooled data by gender (men vs women) and age (< 40 vs ≥ 40 years) across studies; reported P values are nominal (descriptive and unadjusted).
The pooled safety analysis and full analysis sets included 745 and 724 participants, respectively (men, n = 105 and n = 97; women, n = 640 and n = 627; < 40 years, n = 398 and n = 386; ≥ 40 years, n = 347 and n = 338). Across subgroups, most participants had a body mass index ≥ 30 kg/m² (63.0%-75.5%). The mean baseline number of binge eating days/wk was comparable across gender (4.6-4.7) and age (4.6-4.9), as was Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) total score (gender, 20.42-21.70; age, 21.40-21.63). Least squares mean (95% CI) treatment differences nominally favored LDX in all subgroups (all P < .001) for changes from baseline in binge eating days/wk at weeks 11-12 and in Y-BOCS-BE total score at week 12; no interactions by gender or age were reported. Consistent with the overall profile of LDX, across all subgroups LDX was associated with higher frequencies of treatment-emergent adverse events than placebo and with increases in blood pressure and pulse.
Across gender and age, participants exhibited comparable clinical characteristics and responses to dose-optimized LDX compared with placebo.
ClinicalTrials.gov identifiers: NCT01718483 and NCT01718509.
根据性别和年龄描述在被诊断患有中重度暴食障碍（BED）的成年人中，临床特征和拉莫三嗪二甲酯（LDX）的治疗效果。
在两项研究中（分别于 2012 年 11 月 26 日至 2013 年 9 月 25 日[研究 1]和 2012 年 11 月 26 日至 2013 年 9 月 20 日[研究 2]），根据 DSM-IV-TR 中对中重度 BED 的诊断，将被诊断患有中重度暴食障碍的成年人随机分为接受优化剂量 LDX（50 或 70mg）或安慰剂的 12 周治疗。这些事后分析通过性别（男性与女性）和年龄（<40 岁与≥40 岁）在研究间进行了数据合并；报告的 P 值为名义值（描述性和未经调整）。
安全性分析和全分析集分别纳入了 745 例和 724 例参与者（男性：105 例和 97 例；女性：640 例和 627 例；<40 岁：398 例和 386 例；≥40 岁：347 例和 338 例）。在所有亚组中，大多数参与者的 BMI≥30kg/m²（63.0%-75.5%）。性别（4.6-4.7）和年龄（4.6-4.9）间基线每周暴食天数相近，耶鲁-布朗强迫性暴食量表改良版（Y-BOCS-BE）总分也相近（性别：20.42-21.70；年龄：21.40-21.63）。11-12 周时，与基线相比，每周暴食天数和 12 周时 Y-BOCS-BE 总分的最小二乘均值（95%CI）治疗差异在所有亚组中均具有统计学意义（所有 P<.001），且所有亚组中 LDX 均优于安慰剂；未观察到性别和年龄的交互作用。与 LDX 的整体特征一致，在所有亚组中，与安慰剂相比，LDX 治疗均与更高的治疗中出现的不良事件发生率相关，并且与血压和脉搏升高相关。
无论性别和年龄如何，参与者的临床特征和对优化剂量 LDX 的反应均具有可比性。
ClinicalTrials.gov 标识符：NCT01718483 和 NCT01718509。
