This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) for binge eating disorder (BED) in adults. Participants were randomized to placebo or LDX doses of 30, 50, or 70 mg/day for 11 weeks. The primary outcome was reduction in binge eating days per week. Secondary outcomes included reductions in binge episodes, improvements on the Binge Eating Scale and Three-Factor Eating Questionnaire. LDX at 50 and 70 mg/day significantly reduced binge eating days and episodes compared to placebo. LDX also improved binge eating behaviors and attitudes on secondary measures. The most common side effects with LDX were decreased appetite, dry mouth, headache,

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Eligibility Criteria
• The study enrolled adult patients with a body mass index (BMI) ≥25 and ≤45 and who met Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) research criteria for BED, confirmed by the
eating disorders module of the Structured Clinical Interview for DSM-IV-TR disorders and the Eating Disorder
Examination Questionnaire,1,11
as follows:
A. Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
(1) eating, in a discrete period of time (e.g., within any 2-hour period), an amount of food that is definitely larger than
most people would eat in a similar period of time under similar circumstances
(2) a sense of lack of control over eating during the episode (e.g., a feeling that one cannot stop eating or control
what or how much one is eating)
B. The binge-eating episodes are associated with 3 (or more) of the following:
(1) eating much more rapidly than normal
(2) eating until feeling uncomfortably full
(3) eating large amounts of food when not feeling physically hungry
(4) eating alone because of being embarrassed by how much one is eating
(5) feeling disgusted with oneself, depressed, or very guilty after overeating
C. Marked distress regarding binge eating is present.
D. The binge eating occurs, on average, at least 2 days a week for 6 months.
Note: The method of determining the frequency differs from that used for Bulimia Nervosa; future research
should address whether the preferred method of setting a frequency threshold is counting the number of days
on which binges occur or counting the number of episodes of binge eating.
E. The binge eating is not associated with the regular use of inappropriate compensatory behaviors (e.g., purging, fasting,
excessive exercise) and does not occur exclusively during the course of Anorexia Nervosa or Bulimia Nervosa.
Reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision,
Copyright © 2000. American Psychiatric Association
Key Exclusion Criteria
• Current bulimia nervosa, anorexia nervosa, other Axis I/II psychiatric disorders, general medical illness, or disability, that
may confound efficacy and safety assessments
• Montgomery-Åsberg Depression Rating Scale total score ≥18 at screening or baseline visits
• Any lifetime dependence or abuse of stimulants; using psychostimulants for any indication within prior 6 months
• Personal or family history of cardiovascular disease that could increase the participant’s vulnerability to
sympathomimetic effects of a psychostimulant medication
Primary Efficacy Measure and Endpoint
• Binge days determined by clinician assessment of daily self-reported binge diaries and clinician interviews with
participants to identify binge episodes
• Primary efficacy endpoint: change in binge days from baseline at week 11 on the log-transformed scale (number of
binge days/week +1)
Secondary Efficacy Endpoints
• Binge days and episodes per week
• TFEQ, also called the Eating Inventory: categorizes eating behavior by 3 factors with distinctly scored scales5
– Factor I, Cognitive Restraint: dietary restraint; evaluates the conscious mechanisms for restraining food intake or
dietary restraint
– Factor II, Disinhibition: emotionally-based, evaluates lability
– Factory III, Hunger: perceived feeling of hunger and its behavioral consequences
– 51-item self-reported questionnaire assessing 3 dimensions of eating behaviors important in dysregulation of eating
– Sample responses to questions about binge-eating behavior:
• I often stop eating when I am not really full as a conscious means of limiting the amount that I eat (Factor I)
• I get so hungry that my stomach often seems like a bottomless pit (Factor III)
• My weight has hardly changed at all in the last ten years (Factor II)
• Binge Eating Scale
– Total score reflects severity of binge-eating behavior4
• Evaluates 8 behavioral aspects of binge eating and 8 feelings and cognitions associated with binge eating
• Correlates with subjective and objective binge-eating severity
– 16-item self-reported questionnaire: scores ranging from 0 to 46; scores ≥27 indicate severe binge-eating problems;
scores ≤17 indicate little or no binge-eating problems
– Sample responses to questions on how participants feel about binge-eating behaviors (1 selection):
• I do not think about my weight or size when I’m around other people
• I worry about my appearance, but it does not make me unhappy
• I think about my appearance or weight and I feel disappointed in myself
• I frequently think about my weight and feel great shame and disgust
Safety Assessments
• Assessments included treatment-emergent adverse events (TEAEs), Columbia-Suicide Severity Rating Scale
(C-SSRS), vital signs, electrocardiogram, weight, and laboratory tests
Statistical Analyses
• Full analysis set: all participants who took ≥1 dose of study treatment and had ≥1 postbaseline primary efficacy
assessment
• Safety analysis set: all randomized participants who took ≥1 study treatment dose and completed ≥1 follow-up
safety assessment
• Mixed-effects model for repeated measures (MMRM) assessed change from baseline in: transformed scale of log
(binge-eating days/week +1) at week 11 (primary endpoint), binge-eating episodes/week, TFEQ subscale scores,
and BES
RESULTS
Disposition
• 271 participants randomized; safety and efficacy analyses included 270 and 266 participants, respectively
• 58 did not complete the study (placebo, n=17; LDX 30 mg/d, n=15; LDX 50 mg/d, n=13; LDX 70 mg/d, n=13)
– 7 withdrew due to TEAEs (all receiving LDX); none due to lack of efficacy
Demographics and Baseline Characteristics
• Based on BMI, 22.2% of participants were overweight, 58.9% obese, and 18.9% severely obese (Table 1)
Binge Days and Binge Episodes per Week
• Mean (SD) decrease in binge days/wk at week 11/ET was -3.1 (2.09) for placebo; -3.6 (1.97), -4.2 (1.51), and -4.1 (1.55)
for LDX 30, 50, and 70 mg/d
• Change in LS mean (SE) log-transformed binge days/week (primary efficacy measure) significantly decreased with
50 and 70 mg/d LDX doses, but not 30 mg/d vs placebo (Table 2)
• Mean (SD) decrease in binge episodes/wk at week 11/ET was -3.9 (2.80) for placebo; -4.6 (3.24), -5.1 (2.98), and
-5.0 (2.54), for LDX 30, 50, and 70 mg/d
• Change in LS mean (SE) log-transformed binge episodes/week significantly decreased with 50 and 70 mg/d LDX
doses, but not 30 mg/d vs placebo (Table 2)
TFEQ Subscale Scores
• At baseline, mean TFEQ scores for Cognitive Restraint were in the low to average range (0-10) (Figure 2 a-c and
inset tables)
• Baseline scores were in the high (9-11) and clinical (≥12) ranges for Disinhibition and Hunger
• LS mean TFEQ subscale scores for Disinhibition and Hunger were significantly decreased in LDX groups compared
with placebo at week 11, whereas Cognitive Restraint subscale scores were significantly increased
BES Scores
• At baseline, mean BES scores were in the severe range (≥27) (Figure 3 and inset table)
• Greater improvements were observed in all LDX groups vs placebo at week 11
Safety
• For the placebo group: 57.6% (38/66) experienced TEAEs; no deaths, serious TEAEs, or discontinuations because of
TEAEs were reported in the placebo group
• For all LDX dose groups, 82.4% (168/204) experienced TEAEs; 2.9% (6/204) discontinued because of TEAEs;
1.5% (3/204) had serious TEAEs
– 1 participant receiving 70 mg/d LDX died from drug toxicity: methamphetamine and amphetamine levels were
consistent with methamphetamine overdose and not with appropriate study-drug administration
• Participant had a history of substance abuse that was not uncovered during enrollment
• Investigator and sponsor considered this event unrelated to study drug
– 2 participants receiving 30 mg/d LDX experienced unrelated serious TEAEs (acute pancreatitis and appendicitis;
both withdrew due to serious AEs)
• TEAEs reported by ≥10% of participants in all LDX dose groups were decreased appetite, dry mouth, headache,
and insomnia
• Mean (SD) systolic blood pressure (BP) and pulse tended to increase from baseline to week 11/ET with LDX treatment;
no comparable trend was observed for diastolic BP
• For placebo and 30 mg/d, 50 mg/d and 70 mg/d LDX, respectively:
– Mean (SD) change in systolic BP was -2.1 (8.77), -1.0 (10.32), 0.2 (8.84), and 1.3 (10.27) mmHg
– Mean (SD) change in diastolic BP was -1.0 (7.03), -1.4 (7.58), 0.4 (7.42), and -1.2 (7.22) mmHg
– Mean (SD) change in pulse was 1.1 (7.94), 2.1 (9.11), 4.3 (12.44), and 4.6 (12.47) bpm
• Mean (SD) weight was comparable across groups at baseline
– Mean (SD) changes in body weight were -0.0 (6.70) lb for placebo; -7.3 (8.39), -10.9 (9.60), and -11.0 (8.62) lb for
LDX 30, 50, and 70 mg/d (post hoc: percent change significant for each dose vs placebo)
• No clinically meaningful trends were observed for clinical laboratory results or for ECG interval data
conclusions
• LDX treatment with 50 and 70 mg/d decreased number of binge days (primary endpoint: log-transformed binge days)
and binge episodes/week in adults with moderate to severe BED
• Changes in TFEQ subscale scores and BES questionnaire scores with LDX treatment suggest that multiple
behavioral, affective, and attitudinal components of binge-eating behavior and patients’ subjective experience of BED
were positively affected with treatment
– Decreases in BES total scores indicate reduced severity of binge-eating behavior in LDX groups
– Higher TFEQ Cognitive Restraint and lower Disinhibition and Hunger subscores suggest broad changes in
pathological eating behavior of BED associated with LDX treatment
• The safety profile of LDX was consistent with the known safety profile in adults with ADHD12
• Limitations for extrapolating these findings to all BED patients included:
– The demographic profile of participants: mainly female, white, non-Hispanic/non-Latino, and overweight based
on BMI
– Exclusion of participants with other comorbid illnesses/psychiatric conditions
– This study was powered to assess the primary efficacy endpoint; the clinical significance of statistically significant
effects on secondary endpoints, TFEQ, and BES, is undetermined
• Subsequent large, randomized, placebo-controlled trials are required to establish efficacy and safety for this
investigational use
REFERENCES
1. American Psychiatric Association. Washington, DC: American Psychiatric Association; 2000.
2. Hudson JI, Hiripi E, Pope HG, Jr, Kessler RC. Biol Psychiatry. 2007;61(3):348-358.
3. Hudson JI, Lalonde JK, Coit CE, et al. Am J Clin Nutr. 2010;91(6):1568-1573.
4. Timmerman G. J Appl Biobehav Res. 1999;4(1):1-12.
5. Stunkard AJ, Messick S. J Psychosom Res. 1985;29(1):71-83.
6. Latagliata EC, Patrono E, Puglisi-Allegra S, Ventura R. BMC Neurosci. 2010;11:15.
7. Shinohara M, Mizushima H, Hirano M, et al. J Psychiatry Neurosci. 2004;29(2):134-137.
8. Vyvanse [package insert]. Wayne, PA: Shire US Inc.; 2012.
9. Heal DJ, Cheetham SC, Smith SL. Neuropharmacology. 2009;57(7-8):608-618.
10. McElroy S, Mitchell J, Wilfley D, et al. Poster presented at: American College of Neuropsychopharmacology’s
51st Annual Meeting; December 2-6, 2012; Hollywood, FL.
11. Mathes WF, Brownley KA, Mo X, Bulik CM. Appetite. 2009;52(3):545-553.
12. Adler LA, Goodman DW, Kollins SH, et al, on behalf of the 303 Study Group. J Clin Psychiatry. 2008;69(9):
1364-1373.
Lisdexamfetamine Dimesylate Safety and Efficacy on Binge Eating Days/Episodes
and Behavior in Adults With Moderate to Severe Binge Eating Disorder
Susan L. McElroy, MD1
; James Mitchell, MD2
; Denise Wilfley, PhD3
; Maria Gasior, MD, PhD4
; M. Celeste Ferreira-Cornwell, PhD4
;
Scott Crow, MD5
; Michael McKay, MBA4
; Jiannong Wang, PhD4
; James I. Hudson, MD, ScD6
1
Lindner Center of HOPE, Mason, OH; 2
Neuropsychiatric Research Institute, Fargo, ND; 3
Washington University School of Medicine, St. Louis, MO;
4
Shire Development LLC, Wayne, PA; 5
University of Minnesota Medical Center, Minneapolis, MN; 6
McLean Hospital/Harvard Medical School, Belmont, MA
PoSTER NR4-25
The following information concerns a use that has not been
approved by the US Food and Drug Administration.
ABSTRACT
Objectives: To examine the efficacy and safety of lisdexamfetamine dimesylate (LDX) in binge-eating behavior in adults
with moderate to severe binge eating disorder (BED).
Methods: Adults with BED enrolled in a multicenter, randomized, double-blind, forced-dose titration, 11-wk trial of placebo
or LDX (30, 50, or 70mg/d). LDX was initiated at 30mg/d, titrated over 3 wk to assigned dose, and maintained 8 additional
wk. Primary efficacy endpoint was change from baseline to wk 11 in log-transformed (binge days/wk +1). Secondary
measures included binge episodes/wk, Binge Eating Scale (BES), and Three-Factor Eating Questionnaire (TFEQ).Safety
assessments included treatment-emergent adverse events (TEAEs) and vital signs.
Results: 270 randomized participants were included in safety, and 266 (placebo, n=65; LDX: 30mg/d, n=68; 50mg/d,
n=67; 70mg/d, n=66) in efficacy analyses. Baseline mean (SD) binge days/wk were 4.3 (1.35) for placebo; 4.6 (1.45),
4.6 (1.27), and 4.5 (1.26) for LDX 30, 50, and 70mg/d. Mean (SD) decrease in binge days/wk was -3.1 (2.09) for
placebo; -3.6 (1.97), -4.2 (1.51), and -4.1 (1.55) for LDX 30, 50, and 70mg/d. Differences vs placebo in mean change
log-transformed binge days/wk were significant for LDX 50 and 70mg/d (P.001) but not 30mg/d (P=.35). Baseline
mean (SD) binge episodes/wk were 5.2 (2.11) for placebo and 5.8 (3.00), 5.6 (2.71), and 5.5 (2.41) for LDX 30, 50, and
70mg/d.Mean (SD) decrease in binge episodes/wk was -3.9 (2.80) for placebo; -4.6 (3.24), -5.1 (2.98), and -5.0 (2.54), for
LDX 30, 50, and 70mg/d. LDX-placebo differences for mean change log transformed episodes/wk were significant for
50 and 70mg/d (P.001) but not 30mg/d (P=.305).TFEQ subscale change score differences in LS mean (SE) vs placebo
for LDX 30, 50, and 70mg/d were 2.3 (0.88), 1.9 (0.87), 2.3 (0.88) for cognitive restraint; -2.0 (0.77), -2.7 (0.77), and -3.8
(0.77) for disinhibition; and -2.1 (0.78), -2.9 (0.77), and -4.8 (0.77) for hunger (P≤.034 for all). For BES, LDX-placebo
LS mean (SE) differences in change scores were -3.7 (1.74), -5.2 (1.71), and -8.7 (1.73) for 30, 50, and 70mg/d LDX
(P≤.035). On placebo, 57.6% experienced TEAEs, none serious, and no discontinuations for TEAEs. For all LDX groups,
82.4% experienced TEAEs, 1.5% had serious TEAEs, and 2.9% were discontinued for TEAEs; one death was adjudged
unrelated to LDX. Small mean increases in systolic blood pressure and pulse were observed with LDX at wk 11. Mean
(SD) changes in body weight were -0.0 (6.70) lb for placebo; -7.3 (8.39), -10.9 (9.60), and -11.0 (8.62) lb for LDX 30, 50,
and 70mg/d (post hoc: percent change significant for each dose vs placebo).
Conclusion: Adults with moderate to severe BED on 50 and 70mg/d LDX had significant reduction vs placebo in
number of binge days and episodes/wk and improved binge eating behavior. LDX safety profile was consistent with
known effects of LDX.
BACKGROUND
• Binge eating disorder (BED) is characterized by excessive food consumption accompanied by a sense of loss of control
and distress and without regular use of inappropriate compensatory behaviors (eg, purging, fasting, excessive exercise)1
– Lifetime prevalence estimate for BED is ~3% in US adults2
– BED is associated with obesity and may be a predictive factor for components of metabolic syndrome2,3
– Patients with BED frequently have comorbid depression, functional impairments at home and work, and difficulties
in social settings,2
leading to poor quality of life
• Psychometric assessment tools, including the Binge Eating Scale4
(BES) and the Eating Inventory or Three-Factor
Eating Questionnaire5
(TFEQ) may provide perspective on underlying binge-eating behaviors before and after
interventions
• BED has been associated with abnormal signaling by the dopamine (DA) and norepinephrine (NE) neurotransmitter
systems6,7
– Agents that enhance DA/NE signaling may be useful for treatment of BED
• Lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug,8
inhibits reuptake of DA and NE and elicits the release
of monoamine neurotransmitters9
• LDX is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)8
; LDX is not indicated for the treat-
ment of BED
• A randomized, double-blind trial in adults with moderate to severe BED examined the efficacy and safety of LDX given
in fixed doses of 30, 50 and 70 mg/d10
– As previously reported,10
binge days/week (primary measure) decreased versus placebo with 50 and 70 mg/d LDX
(P.001 for each), but not 30 mg/d LDX (P=.35)
– Here we report changes with LDX treatment in behavioral dimensions of BED and on the subjective experience
related to behavioral, affective, and attitudinal components of BED
Objectives
• To examine the effects of LDX versus placebo on primary and secondary endpoints of binge-eating behavior in adults
with moderate to severe BED including:
– Measures of binge days and episode frequency
– Measures of behavioral dimensions and patients’ subjective experience of binge eating
Methods
Study Design
• Multicenter, proof of concept, phase 2, randomized, double-blind, parallel-group, forced-dose titration, placebo-
controlled trial at 31 sites in the United States
• Eligible participants randomized (1:1:1:1) to placebo or 30, 50, or 70 mg/d LDX
• A 3-week forced-dose titration period (initiated at 30 mg/d LDX and titrated in increments of 20 mg/d to the assigned
dose) followed by an 8-week dose-maintenance period (Figure 1)
• Study duration for each patient was planned for 14 weeks
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Figure 1. Study design.
V-1
Screening
Visit
Week-2
V0
Baseline
Visit
Week 0
V1
Week 1
V2
Week 2
V3
Week 3
V4
Week 5
V5
Week 7
V6
Week 9
V7
Week 10
V8/ET
Week 11
Week 12
Follow-Up
Phone
Call
Dose-Maintenance
Period
Forced-Dose Titration
Period
Double-Blind Treatment
Phase
Placebo
30 mg/d LDX
70 mg/d LDX
50 mg/d LDX
ET=early termination.
Clinical research was funded by the sponsor, Shire Development LLC. Under the direction of the authors, Michael Pucci, PhD, an employee of SCI Scientific Communications Information (SCI), provided writing assistance for this poster. Editorial assistance
in formatting, proofreading, copy editing, and fact checking was also provided by SCI. Ryan Dammerman, MD, and Thomas Babcock, DO, from Shire Development LLC, also reviewed
and edited the poster for scientific accuracy. Shire Development LLC provided funding to SCI for support in writing and editing this poster.
Presented at the 166th Annual Meeting of the American Psychiatric Association;
May 18-22, 2013; San Francisco, CA.
Table 1. Demographics and Baseline Characteristics (n=270)
Characteristica
Placebo
n=66
LDX LDX
(All Doses)
n=204
30 mg/d
n=68
50 mg/d
n=68
70 mg/d
n=68
Age, years, mean (SD) 38.3 (10.23) 38.5 (11.01) 39.5 (9.45) 38.6 (10.01) 38.9 (10.13)
Sex, n (%)
Male
Female
16 (24.2)
50 (75.8)
9 (13.2)
59 (86.8)
15 (22.1)
53 (77.9)
10 (14.7)
58 (85.3)
34 (16.7)
170 (83.3)
Ethnicity, n (%)
Hispanic/Latino 5 (7.6) 7 (10.3) 7 (10.3) 10 (14.7) 24 (11.8)
Race, n (%)
White 55 (83.3) 50 (73.5) 55 (80.9) 51 (75.0) 156 (76.5)
BMI, mean (SD) (703×lb/in2
) 34.2 (5.29) 35.0 (5.32) 35.3 (5.70) 35.0 (4.91) 35.1 (5.30)
BMI category, n (%)
Overweight (25 to 30)
Obese (≥30 to 40)
Severely obese (≥40)
15 (22.7)
41 (62.1)
10 (15.2)
14 (20.6)
41 (60.3)
13 (19.1)
16 (23.5)
35 (51.5)
17 (25.0)
15 (22.1)
42 (61.8)
11 (16.2)
45 (22.1)
118 (57.8)
41 (20.1)
a
Baseline value for a characteristic is reported from either the baseline visit or last visit prior to randomization; data are
based on the safety analysis set.
Figure 2 a-c.TFEQ subscale scores at baseline through week 11 (n=266).
0
5
10
15
20
TFEQCognitiveRestraint
Score,Mean(SD)
Baseline Week 3 Week 7 Week 11
IMPROVEMENT
LDX 70 mg/d
Placebo
LDX 30 mg/d
LDX 50 mg/d
a. Cognitive Restraint
Ranges for TFEQ subscale scores: cognitive restraint of eating: 1-10 (low to average), 11-13 (high), and 14 (clinical);
for disinhibition: 0-8 (low to average), 9-11 (high), 12 (clinical); and for hunger, 0-7 (low to average), 8-10 (high), and
11 (clinical).
A score increase indicates improvement for the TFEQ cognitive restraint subscale, and a score decrease indicates
improvement for the TFEQ disinhibition and hunger subscale scores.
0
5
10
15
20
TFEQDisinhibition
Score,Mean(SD)
Baseline Week 3 Week 7 Week 11
IMPROVEMENT
LDX 70 mg/d
Placebo
LDX 30 mg/d
LDX 50 mg/d
b. Disinhibition
-5
0
5
10
15
20
TFEQHunger
Score,Mean(SD)
Baseline Week 3 Week 7 Week 11
IMPROVEMENT
LDX 70 mg/d
Placebo
LDX 30 mg/d
LDX 50 mg/d
c. Hunger
Figure 3. BES scoresa
at baseline through week 11 (n=266).
0
10
20
30
40
50
60
BESScore,Mean(SD)
Baseline Week 3 Week 7 Week 11
IMPROVEMENT
LDX 70 mg/d
Placebo
LDX 30 mg/d
LDX 50 mg/d
a
A score decrease indicates improvement for BES total scores.
Change in BES Scores From Baseline at Week 11 (MMRM)
Treatment Group
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
LS Mean (SE) -12.0 (1.23) -15.7 (1.22) -17.2 (1.19) -20.7 (1.20)
Difference in
LS Mean (SE)
– -3.7 (1.74) -5.2 (1.71) -8.7 (1.73)
P value – .035 .003 .001
Change in Hunger Subscale Score From Baseline at Week 11 (MMRM)
Treatment Group
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
LS Mean (SE) -3.1 (0.56) -5.2 (0.54) -6.0 (0.53) -7.9 (0.54)
Difference in
LS Mean (SE)
– -2.1 (0.78) -2.9 (0.77) -4.8 (0.77)
P value – .007 .001 .001
Change in Disinhibition Subscale Score From Baseline at Week 11 (MMRM)
Treatment Group
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
LS Mean (SE) -3.5 (0.55) -5.5 (0.54) -6.2 (0.53) -7.3 (0.53)
Difference in
LS Mean (SE)
– -2.0 (0.77) -2.7 (0.77) -3.8 (0.77)
P value – .010 .001 .001
Change in Cognitive Restraint Subscale Score From Baseline at Week 11 (MMRM)
Treatment Group
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
LS Mean (SE) 2.2 (0.63) 4.5 (0.61) 4.1 (0.60) 4.6 (0.61)
Difference in
LS Mean (SE)
– 2.3 (0.88) 1.9 (0.87) 2.3 (0.88)
P value – .009 .034 .008
Table 2. Non-Transformed and Log-Transformed Weekly Binge Days and Episodes (n=266a
)
Measures
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
Binge
Days
Non-
transformed
Baseline
Mean (SD)
4.3 (1.35) 4.6 (1.45) 4.6 (1.27) 4.5 (1.26)
Week 11
Mean (SD)
1.1 (1.56) 0.9 (1.49) 0.3 (0.70) 0.1 (0.40)
Log-
transformed
Week 11
LS mean (SE)
changeb
-1.17
(0.068)
-1.26
(0.066)
-1.50
(0.065)
-1.58
(0.066)
Difference in
LS mean (SE)
(LDX-placebo)
–
-0.090
(0.0950)
-0.328
(0.0944)
-0.409
(0.0946)
P value – .35 .001 .001
Placebo
n=65
LDX 30 mg/d
n=68
LDX 50 mg/d
n=67
LDX 70 mg/d
n=66
Binge
Episodes
Non-
transformed
Baseline
Mean (SD)
5.2 (2.11) 5.8 (3.00) 5.6 (2.71) 5.5 (2.41)
Week 11
Mean (SD)
1.3 (1.94) 1.0 (1.89) 0.3 (0.78) 0.1 (0.40)
Log-
transformed
Week 11
LS mean (SE)
changeb
-1.29
(0.072)
-1.39
(0.070)
-1.63
(0.069)
-1.72
(0.070)
Difference in
LS mean (SE)
(LDX-placebo)
–
-0.103
(0.1005)
-0.348
(0.0998)
-0.431
(0.1001))
P value – .305 .001 .001
a
Data are based on the full analysis set; b
Change is from baseline to week 11.