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    3 Comments for this article
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    Comment on Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder
    Daniel J. Luchins, MD | Jesse Brown VAMC, 820 South Damen Ave Chicago, IL 60615

    In their study of  binge-eating disorder (1), McElroy et al, 2015 provide an overview of the literature to underscore the clinical impact of this condition and highlight the limits of current treatment alternatives. They offer evidence from neurochemical studies to support the use of psychostimulants in treating this disorder and describe the results of their controlled trial of lisdexamfetamine.  However, what is not discussed but merits further consideration is the (literally) billion dollar question of why they chose to study  lisdexamfetamine, a dextroamphetamine prodrug currently available only in brand formulation (Vyvanse) over other dextroamaphetamine formulations. That no justification is offered in the text suggests the authors considered that they were studying a drug and not a formulation specific effect and the choice of formulations was based on practical considerations such as the  availability of funding.

    I am therefore curious:  

    1) whether the authors believe this effect would be seen with other formulations of dextroamphetamine, and  if not, why?  

    2) With dramatic price differences amongst formulations, what compelling clinical justification would support the prescription of lisdexamfetamine?

    McElroy SL,  Hudson JI, Mitchell JE, et al: Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: A randomized clinical trial. JAMA Psychiatry. 2015:72(3) 235- 246.



    CONFLICT OF INTEREST: Dr. Luchins is a paid consultant to Express Scripts Inc.
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    The Use of Lisdexamfetamine for Treatment of Binge-Eating Disorder
    Mara Silver, Roisin Byrne, Elia Abi-Jaoude | University of Toronto, Department of Psychiatry
    Dr. McElroy (1) and colleagues recently published a Shire-sponsored multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of lisdexamfetamine (LDX) for adults with Binge Eating Disorder (BED). Patients with BED, excluding all those with other co-morbid psychiatric conditions, were randomized to receive LDX at doses of 30 mg, 50 mg, or 70 mg per day or placebo for 11 weeks. The primary outcome measure was the change in the number of binge-eating days per week. All four patient groups had 4.3-4.6 binge-eating days per week at baseline, and all groups experienced substantial declines in the number of binge-eating days per week, including placebo. The authors highlight that groups treated with 50 mg or 70 mg of LDX had significantly greater drops in their reported numbers of binge-eating days per week compared to placebo (4.1 for LDX doses vs 3.2 days, respectively). In their discussion they suggest that, “these findings provide substantial preliminary evidence that LDX may be effective for treatment of moderate to severe BED…” The difference of 0.9 binge-eating days per week – or 1 binge eating episode (one of the secondary outcomes) – between placebo and high-dose LDX-treated patients is of questionable clinical significance and may simply be the result of unblinding due to adverse effects. In fact, 84.7% of subjects on LDX had treatment-emergent adverse events. These events are well-known to be associated with the stimulant use and include dry mouth, decreased appetite, nausea, constipation, diarrhea, anxiety, feeling jittery, palpitations, insomnia, and sleep disorder. Further, one patient in the study died, reportedly of an unrelated methamphetamine overdose. The authors state, “The safety profile of LDX was generally consistent with that seen in studies of LDX in adults with ADHD;” however, the sizeable effect size of for stimulant treatment in ADHD far exceeds what we see in this study. On balance, when weighed against the questionable clinical effect, the use of LDX for the treatment of BED may produce more harm than good. Further, given that approximately 4 out 5 people with BED have at least one comorbid psychiatric disorder (2), the study sample is grossly unrepresentative of the patients we treat. The authors’ findings demonstrate that short-term intervention, including placebo, for a select sample of people with BED and no co-morbid psychiatric illnesses may lead to short-term reductions in binge eating. Further implications beyond this should be subject to scrutiny. (1) McElroy SL, Hudson JI, Mitchell JE, et al. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: A randomized clinical trial. JAMA Psychiatry. 2015; 72(3):235-246. (2) Hudson JI, Hiripi E, Pope HG, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey replication. Biological Psychiatry. 2007; 61(3): 348-358.
    CONFLICT OF INTEREST: None Reported
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    A possible confounder
    Edward S. Weiss MD | Toronto West Medical
    I was very interested to read McElroy et al. and their finding that lisdexamfetamine may be effective for binge-eating disorder. The authors state that they eliminated confounding due to unintended treatment of ADHD symptoms by excluding subjects with ADHD. However, it is well known that many adults with ADHD have never been diagnosed and may be unaware of the possibility of having it. Unless the authors administered screening tools to rule out ADHD at baseline, it seems very possible that administration of lisdexamfetamine may have been treating subtle underlying features of ADHD which may have been comorbid with, of causative of, the subjects' binge eating. Future studies of the use of psychostimulants in binge-eating disorder should ensure that subjects are free of ADHD symptoms not just by history, but by specific screening or psychological testing.
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    March 2015

    Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial

    Author Affiliations
    • 1Research Institute, Lindner Center of HOPE, Mason, Ohio
    • 2Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio
    • 3Department of Psychiatry, McLean Hospital/Harvard Medical School, Belmont, Massachusetts
    • 4Neuropsychiatric Research Institute, Fargo, North Dakota
    • 5Department of Neuroscience, University of North Dakota School of Medicine, Fargo
    • 6Department of Psychology, Washington University School of Medicine, St Louis, Missouri
    • 7Shire, Wayne, Pennsylvania
    • 8currently with CSL Behring, King of Prussia, Pennsylvania
    • 9currently with Sage Therapeutics, Cambridge, Massachusetts
    JAMA Psychiatry. 2015;72(3):235-246. doi:10.1001/jamapsychiatry.2014.2162
    Abstract

    Importance  Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies.

    Objective  To examine the efficacy and safety of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED.

    Design, Setting, and Participants  We performed a randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively.

    Interventions  Lisdexamfetamine dimesylate at dosages of 30, 50, or 70 mg/d or placebo were provided to study participants (1:1:1:1). Dosages were titrated across 3 weeks and maintained for 8 weeks. We followed up participants for a mean (SD) of 7 (2) days after the last dose.

    Main Outcomes and Measures  We assessed the change in binge-eating (BE) behaviors measured as days per week (baseline to week 11) with a mixed-effects model using transformed log (BE days per week) + 1. Secondary measures included BE cessation for 4 weeks. Safety assessments included treatment-emergent adverse events, vital signs, and change in weight.

    Results  At week 11, log-transformed BE days per week decreased with the 50-mg/d (least squares [LS] mean [SE] change, −1.49 [0.066]; P = .008) and 70-mg/d (LS mean [SE] change, −1.57 [0.067]; P < .001) treatment groups but not the 30-mg/d treatment group (LS mean [SE] change, −1.24 [0.067]; P = .88) compared with the placebo group. Nontransformed mean (SD) days per week decreased for placebo and the 30-, 50-, and 70-mg/d treatment groups by −3.3 (2.04), −3.5 (1.95), −4.1 (1.52), and −4.1 (1.57), respectively. The percentage of participants achieving 4-week BE cessation was lower with the placebo group (21.3%) compared with the 50-mg/d (42.2% [P = .01]) and 70-mg/d (50.0% [P < .001]) treatment groups. The incidence of any treatment-emergent adverse events was 58.7% for the placebo group and 84.7% for the combined treatment group. In the treatment groups, 1.5% of participants had serious treatment-emergent adverse effects. Events with a frequency of at least 5% and changes in heart rate were generally consistent with the known safety profile. The mean (SD) change in body weight was −0.1 (3.09), −3.1 (3.64), −4.9 (4.43), −4.9 (3.93), and −4.3 (4.09) kg for the placebo group, the 30-, 50-, and 70-mg/d treatment groups, and the combined treatment groups, respectively (P < .001 for each dose vs placebo group comparison in post hoc analysis).

    Conclusions and Relevance  The 50- and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days, BE cessation, and global improvement. The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder. Further investigation of lisdexamfetamine in BED is ongoing.

    Trial Registration  clinicaltrials.gov Identifier: NCT01291173

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