Lisdexamfetamine for binge eating disorder.
Lisdexamfetamine is not indicated for weight loss or obesity.
For BED, the initial dosage of lisdexamfetamine is 30 mg/d in the morning, titrated by 20 mg/d per week to the target dosage of 50 to 70 mg/d. Maximum dosage is 70 mg/d. Morning dosing is recommended to avoid sleep disturbance.
The clinical efficacy of lisdexamfetamine was assessed in two 12-week parallel group, flexible-dose, placebo-controlled trials in adults with BED (age 18 to 55). Primary efficacy measure was the number of binge days per week. Both studies had a 4-week dose-optimization period and an 8-week dose-maintenance period and followed the same dosage protocol. Patients began treatment at 30 mg/d and after 1 week were titrated to 50 mg/d; increases to 70 mg/d were made if clinically necessary and well tolerated. Patients were maintained on the optimized dosage during the 8-week dose-maintenance period. A dosage of 30 mg/d did not produce a statistically significant effect, but 50 mg/d and 70 mg/d dosages were statistically superior to placebo. Patients taking lisdexamfetamine also had greater improvement on the Clinical Global Impression--Improvement scores, 4-week binge cessation, and greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating score.
The prescribing information does not state if lisdexamfetamine should be continued long-term for treating BED.
In controlled trials, 5.1% of patients receiving lisdexamfetamine for BED discontinued the drug because of an adverse event, compared with 2.4% of patients receiving placebo. The most common adverse reactions in BED studies were dry mouth (36%), insomnia (20%), decreased appetite (8%), increased heart rate (8%), constipation (6%), and feeling jittery (6%). In trials of children, adolescents, and adults with ADHD, decreased appetite was more common (39%, 34%, and 27%, respectively) than in BED trials (Table 2). Anaphylactic reactions, Stevens-Johnson syndrome, angioedema, and urticaria have been described in postmarketing reports.
The safety of lisdexamfetamine for BED has not been studied in patients age <18, but has been studied in patients with ADHD.
Do not give lisdexamfetamine to patients who have a known hypersensitivity to amphetamine products or other ingredients in lisdexamfetamine capsules.
Lisdexamfetamine is contraindicated in patients who are taking a monoamine oxidase inhibitor, because of a risk of hypertensive crisis.
Source: Vyvanse [package insert]. Wayne, PA: Shire; 2015.
Lisdexamfetamine 30 mg/d did not produce a significant effect, but 50 mg/d and 70 mg/d were statistically superior to placebo
* Wilens TE. Lisdexamfetamine for ADHD. Current Psychiatry. 2007;6(6):96-98, 105.
* Peat CM, Brownley KA, Berkman ND, et al. Binge eating disorder: evidence-based treatments. Current Psychiatry. 2012; 11(5):32-39.
Table 1 Lisdexamfetamine: Fast facts Brand name: Vynanse Class: CNS stimulant Indication: Moderate and severe binge eating Disorder FDA approval date: January 30, 2015 Manufacturer: Shire Dosage forms: 10, 20, 30, 40, 50, 60 and 70 mg capsules Recommended dosage: 30 md/d in the morning, titrated by 20 mg/d per week to 50 to 70 mg/d Table 2 Rates of adverse reactions of lisdexamfetamine fluctuate among patients with BED and those with ADHD Adults with Children with BED ADHD (age 6 to 12) Constipation 6% Not stated Decreased appetite 8% 39% Decreased weight 4% 9% Diarrhea 4% Not stated Dry mouth 36% 5% Feeling jittery 6% 6% Increased heart rate 8% Not stated Irritability/agitation Not stated 10% Insomnia 20% 23% Nausea Not stated 6% Upper abdominal pain 2% 12% Vomiting 2% 9% Adolescents Adults with with ADHD (age ADHD 13 to 17) Constipation Not stated Not stated Decreased appetite 34% 27% Decreased weight 9% 3% Diarrhea Not stated 7% Dry mouth 4% 26% Feeling jittery Not stated 4% Increased heart rate Not stated 2% Irritability/agitation Not stated 3% Insomnia 13% 27% Nausea Not stated 4% Upper abdominal pain Not stated Not stated Vomiting Not stated Not stated ADHD: attention-deficit/hyperactivity disorder; BED: binge eating disorder Source: Vyvanse [package insert]. Wayne, PA: Shire; 2015
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|Title Annotation:||NEW INDICATION|
|Date:||Mar 1, 2015|
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