Deborah Brauser

May 21, 2013

SAN FRANCISCO — A central nervous stimulant, lisdexamfetamine dimesylate (LDX, Vyvanse, Shire), a medication approved for the treatment and maintenance of attention-deficit/hyperactivity disorder (ADHD), may also reduce harmful behaviors in those with binge eating disorder (BED), new research suggests.

The phase 2 trial in adults with moderate to severe BED showed that those who received LDX had significantly fewer bingeing episodes after 11 weeks of treatment compared with the placebo group.

In addition, the safety findings for the medication were "consistent with the known safety profile in adults with ADHD," the investigators report.

"I was very pleased to see how positive these results were," lead author Susan L. McElroy, MD, from the Lindner Center of HOPE in Mason, Ohio, and from the University of Cincinnati, told Medscape Medical News.

"I'm very hopeful that further studies will be as positive, because there are a lot of people with this condition who aren't adequately treated. As a clinician who works with these people, it would be really nice to have this type of option to help them," said Dr. McElroy.

The results were presented here at the American Psychiatric Association's 2013 Annual Meeting.

Frequent Comorbidities

According to the investigators, the lifetime prevalence for BED in adults in the United States is approximately 3%. In addition, it is "associated with obesity and may be a predictive factor for components of metabolic syndrome [and] patients with BED frequently have comorbid depression, functional impairments at home and work, and difficulties in social settings, leading to poor quality of life."

The disorder has also been associated with abnormal signaling by the dopamine (DA) and norepinephrine (NE) neurotransmitter systems.

LDX, which is a D-amphetamine prodrug, "inhibits reuptake of DA and NE and elicits the release of monoamine neurotransmitters," the investigators note.

Dr. Susan McElroy

"There are certain types of psychotherapy that are very helpful for reducing binge eating. But the specialized types aren't widely available. Also, you don't tend to see a reduction in weight," said Dr. McElroy. "So it would be nice to have another tool to help these people."

A total of 270 adults older than 18 years (mean age, 38.8 years; 81.8% women) with BED were enrolled in the study. Of these, 266 were randomly assigned to receive daily either 30 mg (n = 68), 50 mg (n = 67), or 70 mg of LDX (n = 66), or placebo (n = 65) for 11 weeks.

All of the LDX groups were started at the 30-mg dose and then titrated during a period of 3 weeks to their final assigned dose.

The primary outcome measure was change in binge days per week from baseline to end of treatment. Secondary measures included score changes on the Bing Eating Scale (BES) and the Three-Factor Eating Questionnaire (TFEQ), as well as number of binge episodes per week, treatment-related adverse events (AEs), and changes in vital signs.

The baseline mean binge days per week for the placebo group and the LDX 30-, 50-, and 70-mg groups were 4.3, 4.6, 4.6, and 4.5, respectively. The baseline mean binge episodes per week for each of the groups were 5.2, 5.8, 5.6, and 5.5, respectively.

In addition, 22.2% of all participants were overweight, as determined on the basis of body mass index (BMI, 25 to <30), 58.9% were obese (BMI, ≥30 to <40), and 18.9% were severely obese (BMI, ≥40).

Phase 3 Trial in the Works

Results showed that the LDX 50-mg and LDX 70-mg groups had significant decreases in number of binge days per week (-4.2 and -4.1, respectively) compared with the placebo group (-3.1; both comparisons, P < .001).

The LDX 30-mg group had a decrease of 3.6 days, but this was not deemed statistically significant.

Episodes of binge eating per week were also significantly decreased for the LDX 50-mg and LDX 70-mg groups (-5.1 and -5.0, respectively) vs the placebo group (-3.9; both comparisons, P < .001). Again, although those receiving 30 mg of LDX showed a decrease in episodes (-4.6), it was not significant.

All 3 LDX groups showed significant score differences in the TFEQ subscale factors of cognitive restraint, disinhibition, and hunger (P < .034 for all) and in the BES (P < .035 for all).

These findings suggest that "multiple behavioral, affective, and attitudinal components of binge-eating behavior and patients' subjective experience of BED were positively affected with treatment," write the researchers.

"Decreases in BES total scores indicate reduced severity of binge-eating behavior in LDX groups [and] higher TFEQ cognitive restraint and lower disinhibition and hunger subscores suggest broad changes in pathological eating behavior."

Mean weight reductions from baseline to end of treatment for the LDX 30-, 50-, and 70-mg groups were -7.3, -10.9, and -11 pounds, respectively, vs 0 pounds for the placebo group.

For all LDX groups, 82.4% reported AEs (of which 1.5% were serious) vs 57.6% of the placebo group. AEs reported by at least 10% of the LDX groups included decreased appetite, dry mouth, headache, and insomnia.

"Small mean increases in systolic blood pressure and pulse were observed with LDX at week 11," report the investigators.

Dr. McElroy reported that a phase 3 trial assessing LDX for this disorder is currently being conducted.

Dramatic Reductions

"I think this is an interesting study. Its strengths are that it's large and looked at a population that very much needs some assistance," Evelyn Attia, MD, director of the Center for Eating Disorders at New York–Presbyterian Hospital, told Medscape Medical News.

Dr. Evelyn Attia

"In a way, it's a study with not very surprising results. The medication they examined is in the amphetamine family, and these medications are known to decrease appetite. But this study demonstrated across a large sample that this medication was both safe and effective at some of the higher doses," said Dr. Attia, who was not involved with this research.

She noted that it is important to keep in mind that many agents are helpful at decreasing frequency of binge eating, including placebo.

"In this study, the low dose of the medication functioned similarly to placebo. But at the higher doses, there really were very dramatic reductions in the frequency of binge episodes. And that is worthy of some additional attention," she said.

Dr. Attia, who was a member of the eating disorders workgroup for the recently published Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), added that it is important that these patients receive help and that more studies are needed to examine various interventions.

"This condition received a lot of attention when it sat in the back of the book in the DSM-IV. This is a significant group of individuals who are quite dramatically affected by their eating disturbances and is not simply just a group that overeats from time to time," she said.

"They find themselves in a very out-of-control place when it comes to eating more than what is expected for the given situation. They also have many co-occurring psychiatric symptoms, and the idea that there is relief in the form of this medication, or any other, is quite hopeful for a group that has waited a long time to be formally recognized as needing our help."

The study was funded by Shire Development LLC. Dr. Attia reports no relevant financial relationships.

The American Psychiatric Association's 2013 Annual Meeting. Abstract NR4-25. Presented May 19, 2013.

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