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

Kingsley Onokalah, PharmD candidate 2015, Mercer University College of Pharmacy

The Diagnostic and Stastical Manual of Mental Disorders, Fifth Edition (DSM-V) recognizes binge-eating disorder (BED) as a diagnosis.  This disorder is characterized by eating a larger amount of food in a discrete amount of time than most individuals would.  The binge-eating (BE) episodes are associated with eating until uncomfortably full, eating more rapidly normal, and feeling depressed or guilty after eating.1

Lisdexamfetamine dimesylate (brand name: Vyvanse®) is approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults.2  On January 30, 2015, the Food and Drug Admnistration (FDA) announced approval for the use of Vyvanse® for the treatment of BED in adults.3  It is the first FDA-approved medication for this indication. Stoner et al suggest that antidepressants and anticonvulsants may be effective for the treatment of BED, but data showing their long term efficacy is limited.4

Title: Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial
Design Randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial; 260 participants
Objective To examine the efficacy and safety of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED
Study Groups Lisdexamfetamine 30 mg daily (L30) (n= 66), lisdexamfetamine 50 mg daily (L50) (n= 64), lisdexamfetamine 70 mg daily (L70) (n= 63), Placebo daily (n= 62)
Methods Adults (aged 18-55 years) who met diagnostic criteria for BED were randomized (1:1:1:1) to receive placebo or 30, 50, or 70 mg per day of lisdexamfetamine dimesylate (treatment groups). Once-daily oral doses for participants assigned to 30, 50, or 70 mg/day treatment groups were started at the 30 mg/day dosage and titrated weekly in increments of 20 mg/day to the assigned dosage. Dosage changes and reductions were not permitted during the maintenance period; participants could discontinue treatment if they experienced intolerance.
Duration May 10, 2011 through January 30, 2012
Primary outcome measure Change in the number of BE days per week from baseline to week 11 on the log-transformed scale (BE days per week) + 1

Based on clinician interview and confirmation of identified BE episodes in self-reported BE diaries

Baseline Characteristics Amongst all participants:

Age 38.7, 81.5% female, 78% white, BMI 34.9

Results Change from baseline in log-transformed binge days per week at week 11

Placebo: -1.36 (0.072), p= NA

L30: -1.37 (0.070), p= 0.89

L50: -1.62 (0.069), p= 0.009

L70: -1.71 (0.070), p< 0.001

Adverse Events Adverse events reported:

Dry mouth (placebo 7.9%, L30 33.3%, L50 33.8%, L70 36.2%)

Decreased appetite (placebo 6.3%, L30 25.8%, L50 20.0%, L70 18.5%)

Insomnia (placebo 1.6%, L30 10.6%, L50 15.4%, L70 13.8%)

Headache (placebo 9.5%, L30 13.6%, L50 13.8%, L70 7.7%)

Nausea (placebo 0%, L30 7.6%, L50 9.2%, L70 6.2%)

Serious adverse events: N/A
Adverse events that led to trial discontinuation:

There were six participants in the treatment groups that discontinued due to treatment-emergent adverse events.

Study Author Conclusions The 50 mg/day and 70 mg/day treatment groups demonstrated efficacy compared with the placebo group in decreased BE days. Increased efficacy with increasing dosages of lisdexamfetamine suggests a dose-response relationship. Confirmation of these findings in ongoing clinical trials may result in improved pharmacologic treatment for moderate to severe BED.

The investigators of this study were able to show that lisdexamfetamine is effective for the reduction of BE episodes. This is consistent with the later FDA approval of lisdexamfetamine for the treatment of BED. The study may have a potential weakness due to the reliance on self-reported diaries to measure BE days. Future studies could investigate the safety and efficacy of lisdexamfetamine in direct comparison with antidepressants, anticonvulsants, and other stimulants.

References:

  1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Arlington, VA: American Psychiatric Association, 2013. http://dsm.psychiatryonline.org.proxy-s.mercer.edu/doi/full/10.1176/appi.books.9780890425596.dsm10#CIHJIJIC. Accessed March 27, 2015.
  2. McElroy SL, Hudson JI, and 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. http://archpsyc.jamanetwork.com/article.aspx?articleid=2089519. Accessed March 27, 2015.
  3. US Food and Drug Administration. FDA expands uses of Vyvanse® to treat binge-eating disorder. Press Release. January 30, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432543.htm. Accessed March 27, 2015.
  4. Stoner SC, Ruehter VL. Chapter 47. Eating Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014. http://accesspharmacy.mhmedical.com/content.aspx?bookid=689&Sectionid=45310498. Accessed March 28, 2015.
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