Lisdexamfetamine for binge eating disorder: New indication

Lisdexamfetamine, approved by the FDA in 2007 for attention-deficit/hyperactivity disorder (ADHD), has a new indication: binge eating disorder (BED) (Table 1). BED is characterized by recurrent episodes of consuming a large amount of food in a short time. A prodrug of amphet­amine, lisdexamfetamine is a Schedule-II controlled substance, with a high potential for abuse and the risk of severe psychologi­cal or physical dependence.

Lisdexamfetamine is not indicated for weight loss or obesity.

Dosage
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.

Efficacy
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.

Adverse reactions
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.

Contraindications
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.
 

Related Resources
• 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.

Lisdexamfetamine, approved by the FDA in 2007 for attention-deficit/hyperactivity disorder (ADHD), has a new indication: binge eating disorder (BED) (Table 1). BED is characterized by recurrent episodes of consuming a large amount of food in a short time. A prodrug of amphet­amine, lisdexamfetamine is a Schedule-II controlled substance, with a high potential for abuse and the risk of severe psychologi­cal or physical dependence.

Lisdexamfetamine is not indicated for weight loss or obesity.

Dosage
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.

Efficacy
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.

Adverse reactions
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.

Contraindications
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.
 

Related Resources
• 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.

Lisdexamfetamine, approved by the FDA in 2007 for attention-deficit/hyperactivity disorder (ADHD), has a new indication: binge eating disorder (BED) (Table 1). BED is characterized by recurrent episodes of consuming a large amount of food in a short time. A prodrug of amphet­amine, lisdexamfetamine is a Schedule-II controlled substance, with a high potential for abuse and the risk of severe psychologi­cal or physical dependence.

Lisdexamfetamine is not indicated for weight loss or obesity.

Dosage
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.

Efficacy
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.

Adverse reactions
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.

Contraindications
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.
 

Related Resources
• 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.