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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
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)
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. doi:https://doi.org/10.1001/jamapsychiatry.2014.2162
Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies.
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.
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.
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.
clinicaltrials.gov Identifier: NCT01291173
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