Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.
Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
Int J Eat Disord. 2021 May;54(5):872-878. doi: 10.1002/eat.23480. Epub 2021 Feb 3.
This study examined the feasibility, safety, and potential efficacy of lisdexamfetamine (LDX) as a treatment for adults with bulimia nervosa (BN).
An open-label 8-week feasibility study was conducted in participants with BN. Enrollment rate, dropout rate, safety outcomes, and eating disorder symptom change were examined.
Eighteen of 23 participants completed the study per protocol. There was no participant-initiated dropout due to adverse drug reactions and no severe and unexpected adverse drug reactions. An average increase in heart rate of 12.1 beats/min was observed. There was a mean weight reduction of 2.1 kg and one participant was withdrawn for clinically significant weight loss. In the intent-to-treat sample, there were reductions in objective binge episodes and compensatory behaviors from Baseline to Post/End-of-Treatment (mean difference = -29.83, 95% confidence interval: -43.38 to -16.27; and mean difference = -33.78, 95% confidence interval: -48.74 to -18.82, respectively).
Results of this study indicate that a randomized controlled trial would be feasible with close monitoring of certain safety parameters (especially over a longer time period as long-term safety is unknown). However, the results should not be used as evidence for clinicians to prescribe LDX to individuals with BN before its efficacy and safety are properly tested.
NCT03397446.
本研究旨在考察利斯的明（LDX）治疗神经性贪食症（BN）成人患者的可行性、安全性和潜在疗效。
对 BN 患者进行了一项为期 8 周的开放性标签可行性研究。对入组率、脱落率、安全性结果和饮食失调症状变化进行了评估。
根据方案，23 名参与者中有 18 名完成了研究。没有因药物不良反应而导致的参与者主动停药，也没有严重和意外的药物不良反应。观察到平均心率增加 12.1 次/分钟。平均体重减轻 2.1 公斤，有一名参与者因临床显著体重减轻而退出。在意向治疗样本中，客观暴食发作和补偿行为从基线到治疗后/结束时均有减少（平均差值=-29.83，95%置信区间：-43.38 至-16.27；平均差值=-33.78，95%置信区间：-48.74 至-18.82）。
本研究结果表明，在密切监测某些安全参数（特别是在长期内，因为长期安全性未知）的情况下，进行随机对照试验是可行的。然而，在其疗效和安全性得到适当验证之前，这些结果不应被用作临床医生为 BN 患者开处方 LDX 的依据。
NCT03397446。
