ADHD Med May Offer Drug Option for Binge Eating Disorder
Medscape Medical News
January 20, 2015
A drug commonly used to treat attention-deficit/hyperactivity disorder (ADHD) may be safe and effective in treating binge eating disorder (BED) ― a condition with no approved pharmacologic options, early research suggests.
A phase 2, randomized, double-blind, parallel-group study of adults with BED showed that those who received 50 or 70 mg/day of lisdexamfetamine dimesylate (LDX) (Vyvanse, Shire) for 11 weeks had significantly fewer "BE days per week" at the end of the study compared with their peers who received placebo.
Both treatment groups also had significantly higher 4-week BE cessation rates than the placebo group.
Although 85% of the combined treatment groups reported any treatment-emergent adverse events (AEs), compared with 59% of the placebo group, the overall safety profile "was generally consistent with previous findings in adults with ADHD," report the investigators.
"We were a bit surprised by how positive these findings were," lead author Susan L. McElroy, MD, chief research officer at the Lindner Center of HOPE, in Mason, Ohio, and professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine, told Medscape Medical News.
Higher doses of the medication "were superior to placebo in reducing binge eating behaviors and other aspects of [BED], like the obsessive-compulsive features of the condition," said Dr McElroy.
The study was published online January 14 in JAMA Psychiatry.
Most Common Eating Disorder
"At present, no pharmacologic treatments for BED are approved by the US Food and Drug Administration," write the investigators.
They note that LDX is currently approved for the treatment of ADHD in children, adolescents, and adults and is a dextroamphetamine prodrug.
"Agents, such as dextroamphetamine, that inhibit reuptake of [dopamine] and norepinephrine and elicit release of monoamine neurotransmitters may alter pathologic BE and be feasible treatment options for BED," the investigators add.
Dr McElroy noted that BED is the most common eating disorder and is often associated with other psychiatric symptoms. "But it's been neglected at many levels. There's very little knowledge among the medical field about this condition," she said.
"There have been some psychotherapies that are helpful for this condition, but they have not been widely implemented. And because no medication has yet been approved, we thought it was important to try and find out if this particular medication could help."
Adults between the ages of 18 and 55 years with moderate to severe BED were enrolled at 30 sites between May 2011 and January 2012. Eligibility criteria included a body mass index of between 25 and 45.
A total of 260 participants were randomly assigned to receive for 11 weeks placebo (n = 64; 77.8% women; mean age, 38 years) or LDX capsules in doses of 30 (n = 66; 86.4% women; mean age, 38.4 years), 50 (n = 65; 76.9% women; mean age, 39.6 years), or 70 mg/day (n = 65; 84.6% women; mean age, 38.6 years).
"Dosages were titrated across 3 weeks and maintained for 8 weeks," report the researchers. All patients were followed for an additional 7 days after receiving their last dose.
The main outcome measure was decreasing BE days per week. This was determined by measuring changes in BE behaviors from baseline to week 11.
Secondary measures included decreasing BE episodes per week, BE cessation for 4 weeks, and safety profile. For the later measure, AEs, vital signs, and weight change were all examined. In addition, the Clinical Global Impressions?Improvement (CGI-I) Scale was used to measure symptom improvements.
Other measures used included the self-reported Three-Factor Eating Questionnaire (TFEQ) and Bing Eating Scale (BES), the Yale-Brown Obsessive Compulsive Scale for BE (YBOCS-BE), and version 11 of the Barratt Impulsiveness Scale (BIS-11), version 2 of the 12-item Short Form Health Survey (SF-12), the Montgomery??sberg Depression Rating Scale (MADRS), and the Hamilton Anxiety Rating Scale (HAM-A).
There were 17 discontinuations in the placebo group vs 15 in the 30-mg/day group and 13 each in the 50- and 70-mg/day groups.
Still Early
Results showed that, compared with the placebo group, there was a significant decrease in BE days per week for both the 70-mg/day LDX group (P < .001) and the 50-mg/day LDX group (P = .008).
BE episodes per week also decreased for the 70- and 50-mg/day treatment groups (P < .001 and P = .009, respectively) vs placebo; and 1-week BE response was significantly better (P = .002 and .006, respectively).
There were no significant differences in any of these measures between those receiving 30 mg/day of LDX and those receiving placebo.
Compared with 21.3% of the placebo group, 50% of the 70-mg/day treatment group and 42.2% of the 50-mg/day treatment group achieved 4-week BE cessation (P < .001 and P = .01, respectively).
Significant improvements for the two highest treatment dosage groups were also found on CGI-I scores (P < .001 vs placebo for both groups), BES total scores (P < .001 and P = .002, respectively), and YBOCS-BE scores (P < .001 and P = .008, respectively).
According to the TFEQ, perceived hunger also decreased significantly from baseline for both the 70-mg and 50-mg groups (P < .001 for both), as did disinhibition of eating (P < .001 and P = .002, respectively). "Cognitive restraint of eating" decreased significantly only for the 70-mg group (P = .046).
Those receiving 70 mg/day of LDX were also the only ones to show significant improvements vs placebo on the BIS-11 total score and SF-12 Aggregate Physical Health Component Summary score (P = .02 for both measures).
There were no significant between-group differences on MADRS or HAM-A scores. Baseline mean scores on these two measures "indicated that depression and anxiety symptoms were low across all groups," write the investigators.
Incidence of treatment-emergent AE was 58.7% for the placebo group and 84.7% in the combined treatment groups. A total of 1.5% of the latter group reported experiencing serious AEs.
"Mean heart rate tended to increase from baseline to week 11 or early termination with lisdexamfetamine treatment," the researchers write. But no trends were observed for systolic or diastolic blood pressure or electrocardiography interval.
The mean change in body weight was -0.1 kg for the placebo group vs -3.1 for the 30-mg/day LDX group and -4.9 for each of the 50- and 70-mg/day groups. The mean change was -4.3 kg for the combined treatment group.
"Together, these findings provide substantial preliminary evidence that [LDX] may be effective for treatment of moderate to severe BED," write the investigators.
However, "this is a phase 2 study, and although it was positive, it's just one study and extremely preliminary," added Dr McElroy. She reported that two phase 3 studies have now been conducted in larger populations, and she is looking forward to seeing the published results.
"It's important to reinforce that lisdexamfetamine is not indicated by the FDA for BED. I think the message for clinicians at this point is just to become aware of the disorder to be better able to identify it in patients," she concluded.
"Desperate" Need for Treatments
Preliminary results from this study were presented at the 2013 American Psychiatric Association Annual Meeting in San Francisco, California.
At that time, Evelyn Attia, MD, director of the Center for Eating Disorders at New York?Presbyterian Hospital, told Medscape Medical News that this research was "interesting" and looked at a population that desperately needs assistance.
"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," she said.
"But this study demonstrated across a large sample that [it] was both safe and effective at some of the higher doses," added Dr Attia, who was not involved with the research.
She noted that the idea of relief from any medication "is quite hopeful for a group that has waited a long time to be formally recognized as needing our help."
The study authors have reported several financial relationships, which are fully listed in the original article. Dr Attia has reported no relevant financial relationships.
JAMA Psychiatry. Published online January 14, 2015. Abstract
Medscape Medical News
January 20, 2015
A drug commonly used to treat attention-deficit/hyperactivity disorder (ADHD) may be safe and effective in treating binge eating disorder (BED) ― a condition with no approved pharmacologic options, early research suggests.
A phase 2, randomized, double-blind, parallel-group study of adults with BED showed that those who received 50 or 70 mg/day of lisdexamfetamine dimesylate (LDX) (Vyvanse, Shire) for 11 weeks had significantly fewer "BE days per week" at the end of the study compared with their peers who received placebo.
Both treatment groups also had significantly higher 4-week BE cessation rates than the placebo group.
Although 85% of the combined treatment groups reported any treatment-emergent adverse events (AEs), compared with 59% of the placebo group, the overall safety profile "was generally consistent with previous findings in adults with ADHD," report the investigators.
"We were a bit surprised by how positive these findings were," lead author Susan L. McElroy, MD, chief research officer at the Lindner Center of HOPE, in Mason, Ohio, and professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine, told Medscape Medical News.
Higher doses of the medication "were superior to placebo in reducing binge eating behaviors and other aspects of [BED], like the obsessive-compulsive features of the condition," said Dr McElroy.
The study was published online January 14 in JAMA Psychiatry.
Most Common Eating Disorder
"At present, no pharmacologic treatments for BED are approved by the US Food and Drug Administration," write the investigators.
They note that LDX is currently approved for the treatment of ADHD in children, adolescents, and adults and is a dextroamphetamine prodrug.
"Agents, such as dextroamphetamine, that inhibit reuptake of [dopamine] and norepinephrine and elicit release of monoamine neurotransmitters may alter pathologic BE and be feasible treatment options for BED," the investigators add.
Dr McElroy noted that BED is the most common eating disorder and is often associated with other psychiatric symptoms. "But it's been neglected at many levels. There's very little knowledge among the medical field about this condition," she said.
"There have been some psychotherapies that are helpful for this condition, but they have not been widely implemented. And because no medication has yet been approved, we thought it was important to try and find out if this particular medication could help."
Adults between the ages of 18 and 55 years with moderate to severe BED were enrolled at 30 sites between May 2011 and January 2012. Eligibility criteria included a body mass index of between 25 and 45.
A total of 260 participants were randomly assigned to receive for 11 weeks placebo (n = 64; 77.8% women; mean age, 38 years) or LDX capsules in doses of 30 (n = 66; 86.4% women; mean age, 38.4 years), 50 (n = 65; 76.9% women; mean age, 39.6 years), or 70 mg/day (n = 65; 84.6% women; mean age, 38.6 years).
"Dosages were titrated across 3 weeks and maintained for 8 weeks," report the researchers. All patients were followed for an additional 7 days after receiving their last dose.
The main outcome measure was decreasing BE days per week. This was determined by measuring changes in BE behaviors from baseline to week 11.
Secondary measures included decreasing BE episodes per week, BE cessation for 4 weeks, and safety profile. For the later measure, AEs, vital signs, and weight change were all examined. In addition, the Clinical Global Impressions?Improvement (CGI-I) Scale was used to measure symptom improvements.
Other measures used included the self-reported Three-Factor Eating Questionnaire (TFEQ) and Bing Eating Scale (BES), the Yale-Brown Obsessive Compulsive Scale for BE (YBOCS-BE), and version 11 of the Barratt Impulsiveness Scale (BIS-11), version 2 of the 12-item Short Form Health Survey (SF-12), the Montgomery??sberg Depression Rating Scale (MADRS), and the Hamilton Anxiety Rating Scale (HAM-A).
There were 17 discontinuations in the placebo group vs 15 in the 30-mg/day group and 13 each in the 50- and 70-mg/day groups.
Still Early
Results showed that, compared with the placebo group, there was a significant decrease in BE days per week for both the 70-mg/day LDX group (P < .001) and the 50-mg/day LDX group (P = .008).
BE episodes per week also decreased for the 70- and 50-mg/day treatment groups (P < .001 and P = .009, respectively) vs placebo; and 1-week BE response was significantly better (P = .002 and .006, respectively).
There were no significant differences in any of these measures between those receiving 30 mg/day of LDX and those receiving placebo.
Compared with 21.3% of the placebo group, 50% of the 70-mg/day treatment group and 42.2% of the 50-mg/day treatment group achieved 4-week BE cessation (P < .001 and P = .01, respectively).
Significant improvements for the two highest treatment dosage groups were also found on CGI-I scores (P < .001 vs placebo for both groups), BES total scores (P < .001 and P = .002, respectively), and YBOCS-BE scores (P < .001 and P = .008, respectively).
According to the TFEQ, perceived hunger also decreased significantly from baseline for both the 70-mg and 50-mg groups (P < .001 for both), as did disinhibition of eating (P < .001 and P = .002, respectively). "Cognitive restraint of eating" decreased significantly only for the 70-mg group (P = .046).
Those receiving 70 mg/day of LDX were also the only ones to show significant improvements vs placebo on the BIS-11 total score and SF-12 Aggregate Physical Health Component Summary score (P = .02 for both measures).
There were no significant between-group differences on MADRS or HAM-A scores. Baseline mean scores on these two measures "indicated that depression and anxiety symptoms were low across all groups," write the investigators.
Incidence of treatment-emergent AE was 58.7% for the placebo group and 84.7% in the combined treatment groups. A total of 1.5% of the latter group reported experiencing serious AEs.
"Mean heart rate tended to increase from baseline to week 11 or early termination with lisdexamfetamine treatment," the researchers write. But no trends were observed for systolic or diastolic blood pressure or electrocardiography interval.
The mean change in body weight was -0.1 kg for the placebo group vs -3.1 for the 30-mg/day LDX group and -4.9 for each of the 50- and 70-mg/day groups. The mean change was -4.3 kg for the combined treatment group.
"Together, these findings provide substantial preliminary evidence that [LDX] may be effective for treatment of moderate to severe BED," write the investigators.
However, "this is a phase 2 study, and although it was positive, it's just one study and extremely preliminary," added Dr McElroy. She reported that two phase 3 studies have now been conducted in larger populations, and she is looking forward to seeing the published results.
"It's important to reinforce that lisdexamfetamine is not indicated by the FDA for BED. I think the message for clinicians at this point is just to become aware of the disorder to be better able to identify it in patients," she concluded.
"Desperate" Need for Treatments
Preliminary results from this study were presented at the 2013 American Psychiatric Association Annual Meeting in San Francisco, California.
At that time, Evelyn Attia, MD, director of the Center for Eating Disorders at New York?Presbyterian Hospital, told Medscape Medical News that this research was "interesting" and looked at a population that desperately needs assistance.
"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," she said.
"But this study demonstrated across a large sample that [it] was both safe and effective at some of the higher doses," added Dr Attia, who was not involved with the research.
She noted that the idea of relief from any medication "is quite hopeful for a group that has waited a long time to be formally recognized as needing our help."
The study authors have reported several financial relationships, which are fully listed in the original article. Dr Attia has reported no relevant financial relationships.
JAMA Psychiatry. Published online January 14, 2015. Abstract
