Safety and Efficacy of Lorcaserin: A Combined Analysis of The BLOOM and BLOSSOM Trials

C L I N I C A L F O C U S : M E TA B O L I C S Y N D R O M E , D I A B E T E S , A N D I M M U N I Z AT I O N S
Safety and Efficacy of Lorcaserin: A Combined

Analysis of the BLOOM and BLOSSOM Trials
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DOI: 10.3810/pgm.2014.10.2817
Louis Aronne, MD 1
William Shanahan, MD 2
Randi Fain, MD 3
Alan Glicklich, MD 2
William Soliman, PhD 3
Yuhan Li, MS 3
Steven Smith, MD 4,5
Department of Medicine, Weill
Cornell Medical College, New York
City, NY; 2Clinical Development,
Arena Pharmaceuticals Inc., San
Diego, CA; 3Eisai Medical and
Scientific Affairs, Eisai Inc., Woodcliff
Lake, NJ; 4Diabetes and Obesity
Research Center, Sanford/Burnham
Medical Research Institute at Lake
Nona, Orlando, FL; 5Translational
Research Institute for Metabolism and
Diabetes, Florida Hospital, Orlando, FL
1
Abstract
Background: Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the US

Food and Drug Administration (FDA) for weight management in combination with lifestyle
modification for adults with obesity and adults with overweight and $1 weight-related comorbid
condition. The safety and effectiveness of lorcaserin in adult patients without type 2 diabetes
mellitus was established based on 2 phase III clinical trials of similar design: Behavioral
Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) and Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM). This
report presents a prespecified analysis of pooled data from these trials. Methods: Co-primary
end points in this analysis include the proportion of patients with a reduction in baseline body
weight of $ 5% and $ 10%, and a change in weight from baseline. Key secondary end points
include changes from baseline values in lipid parameters, quality-of-life measures, glycemic
indicators, and vital signs. Results: At week 52, more than twice as many lorcaserin-treated
patients achieved a weight loss of $ 5% compared with placebo (lorcaserin, 47.1%; placebo,
22.6%), and lorcaserin-treated patients lost significantly more body weight (lorcaserin, 5.8%;
placebo, 2.5%). A significantly greater proportion of lorcaserin-treated patients achieved
a weight loss of $ 10% (lorcaserin, 22.4%; placebo, 8.7%). There were statistically significant
improvements in lipid parameters, glycemic indicators, quality-of-life measures, and vital signs
in the lorcaserin group compared with placebo. The most common adverse events associated
with lorcaserin treatment were headache, upper respiratory tract infection, and nasopharyngitis. Lorcaserin-treated patients had a rate of FDA-defined valvulopathy similar to placebo.
Conclusions: This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that
lorcaserin 10mg twice daily, in combination with diet and exercise, is safe and tolerable, and
is associated with statistically significant weight loss and clinically relevant improvements in
cardiometabolic parameters.
Keywords: obesity; pharmacotherapy; BLOOM; BLOSSOM; lorcaserin
Introduction
Correspondence: Louis Aronne, MD,
Sanford I. Weill Professor of Metabolic
Research,
Weill Cornell Medical College,
Comprehensive Weight Control Center,
1165 York Avenue,
New York, NY 10065.
Tel: 646-962-2111
Fax: 212-832-9495
E-mail: ljaronne@med.cornell.edu
Overweight and obesity rates have reached epidemic proportions in the United States.
The National Center for Health Statistics reports that from 20112012more than onethird of US adults were obese.1 In the primary care setting, behavioral modification
has failed to produce clinically meaningful weight loss in patients,2 and studies suggest that physician counseling results in a mean weight loss of,2.5kg during a 6 to
12month period.3 Pharmacotherapy can play a significant role in weight management
and may be used to enhance weight loss beyond what is normally achieved with diet
and exercise (DE) alone.
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Aronne etal
Calorie restriction results in a rapid and profound

physiologic response to defend against perceived starvation.4 In a fasting state, small decreases in fat mass lead
to decreases in the appetite-suppressing hormone leptin.5
A clinical study by Sumithran etal4 showed that changes
in appetite-regulating hormones after weight loss favor
increasing energy stores. After weight loss, patients had
decreased levels of the appetite-suppressing hormone leptin,
had elevated levels of the appetite-stimulating hormone
ghrelin, and experienced increased hunger. 4 Therefore,
a strong biological basis exists for the difficulties patients
experience when attempting to lose weight. Safe and effective
pharmacological treatments that control hunger and increase
satiety should be considered as a measure to supplement DE
to achieve weight loss goals.
Energy balance and satiety are regulated in part by the proopiomelanocortin and cocaine- and amphetamine-regulated
transcript (POMC/CART), and agouti-related protein and
neuropeptide Y (AgRP/NPY) neurons in response to serotonin and other chemical mediators within the hypothalamus.6
Among the research-focused approaches to weight loss
are satiety-producing agents that target serotonin (5-HT)
receptors.6,7 The 5-HT2C receptor subtype is a mediator of
serotonins effects on ingestive behavior.7 Previous nonselective serotonergic agents were associated with cardiac
valvular insufficiency and psychiatric side effects because
of activation of the 5-HT2B and 5-HT2A receptor subtypes,
respectively.8,9 Perhaps as a result of the historical side-effect
profile of multiple agents, some of which have since been
withdrawn from the market, primary care physicians (PCPs)
remain hesitant to prescribe pharmacological interventions
for weight loss,3 despite the fact that clinical trials in adults
with overweight and obesity have clearly demonstrated that
combining pharmacotherapy with lifestyle modifications produces greater weight loss than lifestyle modification alone.2,3
In a survey of physicians recommendations for weight loss
strategies, pharmacotherapy was the recommendation made
the least.10 In another recent survey of attitudes and confidence in managing obesity, a mere 3.8% of family physicians
and general internists believed that medications for weight
loss were safe.11 A serotonergic agent with selectivity for the
5-HT2C receptor could be a valuable tool for PCPs to use for
treatment of overweight and obesity.
Lorcaserin is a selective 5-HT2C receptor agonist,9 which
is thought to regulate satiety centers in the brain through
activation of POMC neurons in the arcuate nucleus of the
hypothalamus.12 Consistent with this hypothesis, lorcaserin
has been shown to regulate body weight by reducing energy
8
intake rather than altering energy expenditure.13 Lorcaserin is

approved by the US Food and Drug Administration (FDA) for
weight management in combination with lifestyle modification for adults who are obese with a body mass index (BMI)
$30kg/m2, and in adults who are overweight with a BMI
$27kg/m2 with $1 weight-related comorbid condition,
including type 2 diabetes mellitus.14 Two phase III clinical
trials were conducted in adults without diabetes who were
overweight or obese to establish the safety and efficacy of
lorcaserin in this population: the Behavioral Modification
and Lorcaserin for Overweight and Obesity Management
(BLOOM; N = 3182) and Behavioral Modification and
Lorcaserin Second Study for Obesity Management (BLOSSOM; N =4008) trials.15,16 Results from BLOOM and
BLOSSOM indicated that significantly more patients in the
group treated with lorcaserin lost $5% and $10% of body
weight, respectively, compared with placebo after 1 year of
treatment.15,16 Furthermore, there was no apparent increased
risk of cardiac valvulopathy associated with lorcaserin use in
either trial.1517 Patients who were overweight or obese with
poorly controlled type 2 diabetes mellitus were studied in
a third, smaller phase III study (BLOOM-DM; N=604) to
determine a weight management indication in this population18; these data are not included in this report.
The BLOOM and BLOSSOM trials were designed to
include almost identical patient populations and end points
to support pooling of the data for analysis. Data from the
BLOOM-DM trial were not prespecified for this pooled
analysis because of historical differences in the safety and
efficacy profile of patients with diabetes in clinical trials
of weight management. This report presents a prespecified
analysis of pooled data from the BLOOM and BLOSSOM
trials including the same co-primary end points that were
designated for the individual trials. Analyses of prespecified
secondary end points include lipid parameters, glycemic
indicators, quality-of-life measures, and vital signs. Pooled
safety findings are also discussed. This is the largest obesity
pharmacotherapy trial dataset published to date within the
US that provides sufficient statistical power to evaluate safety
and efficacy parameters that may be of clinical relevance and
not amenable to assessment in smaller databases.
Materials and Methods

Trial Designs
The BLOOM and BLOSSOM studies were phase III, randomized, double-blind, placebo-controlled clinical trials
designed to evaluate the efficacy and safety of lorcaserin in
patients without diabetes who were obese or overweight. Key
Postgraduate Medicine, Volume 126, Issue 6, October 2014, ISSN 0032-5481, e-ISSN 1941-9260

Combined Analysis of the BLOOM and BLOSSOM Trials
inclusion criteria for both studies were age 18 to 65years

(inclusive) and a BMI of between 30 and 45kg/m2 for those
who were obese, or patients who were overweight with a
BMI of 27 to 29.9kg/m2 and $1 coexisting condition (ie,
hypertension, dyslipidemia, cardiovascular disease, impaired
glucose tolerance, or sleep apnea). Key exclusion criteria
included recent cardiovascular events, diabetes mellitus, use
of serotonergic antidepressants, and high blood pressure.15,16
During the 2-year course of the BLOOM trial, patients
received either lorcaserin 10mg, twice daily, in combination with DE (lorcaserin DE) or placebo, twice daily, in
combination with DE (placebo DE) for the first year. For the
second year, those in the lorcaserin DE group were randomly
reassigned to continue lorcaserin DE or switch to placebo
DE.15 During the 1-year BLOSSOM trial, patients received
either lorcaserin twice daily DE, lorcaserin 10mg once daily
in combination with DE, or placebo DE.16 Since only twice
daily dosing of lorcaserin and a 1-year duration were common to both studies, only 1-year data and twice daily dosing
are discussed. Individual reports of the BLOOM and BLOSSOM trials are published elsewhere.15,16 A pooled analysis
of echocardiographic data from all 3 lorcaserin phase III
studies (BLOOM, BLOSSOM, and BLOOM-DM) has also
been published,17 but this is the first publication of pooled
data from BLOOM and BLOSSOM in a patient population
without diabetes.
Study Assessments
Co-primary end points included evaluation at week 52 with

a closed testing procedure preserving the overall type I
error of 0.05: the proportion of patients with a reduction in
baseline body weight of $5%, the change in weight from
baseline, and the proportion of patients with a reduction
in baseline body weight of $10%.15,16 Key secondary end
points included changes from baseline values in lipid parameters (triglycerides [TG], total cholesterol [TC], low-density
lipoprotein [LDL], LDL cholesterol [LDL-C], and highdensity lipoprotein cholesterol [HDL-C]), glycemic indicators (hemoglobin A1c [HbA1c] and fasting plasma glucose),
quality-of-life measurements, and cardiovascular vital signs
(systolic and diastolic blood pressures, and heart rate).15,16
Quality of life was evaluated using the Impact of Weight
on Quality of Life-Lite (IWQOL-Lite) questionnaire.15,16
Anthropometric measurements (waist circumference and
BMI) and echocardiography data were also captured.
Echocardiographic criteria were used to determine the incidence of FDA-defined valvulopathy (mild or greater aortic
regurgitation, or moderate or greater mitral regurgitation)
from baseline to week 52.15,16 Differences in incidence were

calculated using the Cochran-Mantel-Haenszel weighted
normal approximation method with stratification by protocol.
The present analysis includes data collected through week 52,
because only the BLOOM study extended into week 104.
Populations
Patient groups discussed in this analysis include the modified

intention-to-treat (MITT), completer, and safety populations.
The MITT population includes all randomized patients
who received $1 dose of study medication and who had
1post-baseline body weight assessment. Data collected after
discontinuation of study treatment were not included, and
the last-observation-carried-forward method was used for
missing data. In order to assess efficacy in patients who
continued on therapy for the full year, a second population
was evaluated: the completers (ie, the completer population),
which includes all patients who remained on the study until
week 52. No compliance threshold was required for inclusion
in the completer population. The safety population includes
all patients who received $1 dose of study medication.
For laboratory-based measurements, $1 test of each lab
measure post-randomization was required for its inclusion
in the safety population data.
Results
Patient Demographics and Baseline
Characteristics
The pooled safety population includes 3195 patients treated

with lorcaserin DE and 3185 patients treated with placebo
DE (Table1; Figure1). The majority of patients were women
(lorcaserin DE, 81.7%; placebo DE, 81.0%). Demographic
characteristics, including age, sex, race, body weight, height,
and BMI, were similar between the lorcaserin DE and placebo
DE groups and are consistent with the individual studies.15,16
In the pooled population and consistent with other weight
management trials,19,20 rates of patients who completed
52 weeks of treatment were 56.3% for lorcaserin DE and
48.6% for placebo DE (Figure1). Baseline characteristics,
including lipid parameters, glycemic indicators, vital signs,
and questionnaire scores, were similar between the groups
(Table1).
Pooled Primary Analysis

Weight Loss
Pooled data from the BLOOM and BLOSSOM trials included

a total of 6136 patients in the MITT population randomly
assigned to receive lorcaserin DE or placebo DE. In this
Aronne etal
Table 1. Demographic Profile and Baseline Characteristics of Pooled BLOOM and BLOSSOM Patients (Safety Population)

Demographic/Baseline Characteristics
Placebo
(N = 3185)
Lorcaserin, 10 mg BID
(N = 3195)
2580 (81.0%)
605 (19.0%)
2610 (81.7%)
585 (18.3%)
44.0 (11.4)
44.0
1866
26.0%
43.8 (11.6)
44.0
1866
26.4%
167 (5.2%)
564 (17.7%)
869 (27.3%)
910 (28.6%)
674 (21.2%)
1 (0.0%)
185 (5.8%)
555 (17.4%)
871 (27.3%)
935 (29.3%)
648 (20.3%)
1 (0.0%)
2110 (66.2%)
617 (19.4%)
19 (0.6%)
14 (0.4%)
394 (12.4%)
9 (0.3%)
22 (0.7%)
2161 (67.6%)
604 (18.9%)
24 (0.8%)
18 (0.6%)
355 (11.1%)
11 (0.3%)
22 (0.7%)
100.2 (15.9)
98.7
62.7165.9
15.9%
100.4 (15.7)
99.0
62.6159.3
15.6%
166.5 (8.5)
165.1
141.0203.2
5.1%
166.5 (8.7)
165.2
138.2198.0
5.2%
36.1 (4.2)
35.6
26.746.6
11.7%
36.1 (4.3)
35.8
26.752.5
11.8%
# 30
149 (4.7%)
169 (5.3%)
. 30 but # 35
1297 (40.7%)
1244 (38.9%)
. 35 but # 40
1092 (34.3%)
1118 (35.0%)
. 40
Lipid Parameters (mean; mg/dL)*
Triglycerides
Total cholesterol
LDL cholesterol
HDL cholesterol
Diabetes Status
Glycemic Indicators (mean)*
HbA1c (%)
Fasting plasma glucose (mg/dL)
647 (20.3%)
664 (20.8%)
137.0
194.8
114.1
53.5
Negative
135.4
194.4
114.3
53.2
Negative
5.6
92.4
5.6
92.1
Gender, n (%)
Female
Male
Age (y)
Mean (SD)
Median
Range
CV
Age Group, n (%)
1824
2534
3544
4554
5565
. 65
Race, n (%)
White or Caucasian
Black or African American
Asian
North American Indian or American Native
Hispanic or Latino
Native Hawaiian or other Pacific Islander
Other
Weight (kg)
Mean (SD)
Median
Range
CV
Height (cm)
Mean (SD)
Median
Range
CV
BMI (kg/m2)
Mean (SD)
Median
Range
CV
BMI Group (kg/m2)
(Continued)
10
Table 1. (Continued)
Demographic/Baseline Characteristics
Vital Signs (mean)*
Systolic blood pressure (mmHg)
Diastolic blood pressure (mmHg)
IWQOL-Lite Questionnaire Score (mean)*
Placebo
(N = 3185)
Lorcaserin, 10 mg BID
(N = 3195)
121.5
77.7
74.6
121.4
77.4
74.3

Abbreviations: BID, twice daily; BLOOM, Behavioral Modification and Lorcaserin for Overweight and Obesity Management; BLOSSOM, Behavioral Modification and
Lorcaserin Second Study for Obesity Management; BMI, body mass index; CV, coefficient of variation; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; IWQOL-Lite,
Impact of Weight on Quality of Life-Lite; LDL, low-density lipoprotein; MITT, modified intention-to-treat; SD, standard deviation.
*
These parameters are presented for the MITT population.
patient population, lorcaserin DE was superior to placebo

DE for those who achieved a weight loss of $5% relative
to baseline. After 52 weeks, 47.1% of lorcaserin DEtreated
patients had achieved a weight loss of $5%, which was more
than twice the proportion compared with placebo DE (22.6%;
P,0.001; Figure2A). Furthermore, pooled analysis of the
MITT population showed that the mean percentage loss in
body weight was significantly greater in patients treated with
lorcaserin DE (5.8%) than those who received placebo DE
(2.5%) at week 52 (P,0.001; Figure2B). After 52 weeks
of treatment with lorcaserin DE, 22.4% of patients in the
MITT population achieved $10% reduction in body weight
compared with only 8.7% in the pooled placebo DE group
(P,0.001; Figure2A).
In the pooled completer population, 63.9% of lorcaserin
DEtreated patients achieved a weight loss of $5% versus
33.5% for the placebo DEtreated patients (P ,0.001;
Figure2A). Patients in the completer population who
received lorcaserin DE had a higher mean percentage of

weight loss (8.0%) than those in the MITT population; the
percent of weight loss was also significantly greater than in
completers who received placebo DE (3.7%; P,0.001;
Figure2B). Analysis of the completer population showed
that a greater percentage of lorcaserin DEtreated patients
achieved a weight loss of $10% compared with placebo
DEtreated patients (34.7% vs 14.7%, respectively;
P,0.001; Figure2A).
Patients receiving lorcaserin DE had a greater reduction
in anthropometric measures than those receiving placebo
DE at week 52. The mean change from baseline in waist
circumference in the MITT population was 6.5cm for the
lorcaserin DE group and 4.0cm for the placebo DE group
(P,0.001). In the same population, the mean change from
baseline for BMI was 2.1kg/m2 for the lorcaserin DE group
and 0.9kg/m2 for the placebo DE group (P,0.001). In the
completer population, mean change from baseline in waist
Figure1. Patient randomization and disposition in the pooled population.
Abbreviations: BID, twice daily; MITT, modified intention-to-treat; PI, principal investigator.
Aronne etal

Figure2. The effect of lorcaserin treatment on body weight. (A) Percentage of patients who lost $5% or $10% of their baseline body weight at week 52. (B) Mean
percentage change from baseline in body weight. Statistical comparisons of lorcaserin DE and placebo DE at week 52 within MITT and completer populations only.
*P,0.001.
Abbreviations: completers, completer population; DE, diet and exercise; MITT, modified intention-to-treat.
circumference was 8.2cm and 5.0cm for the lorcaserin

DE and placebo DE groups, respectively (P,0.001), and
mean change from baseline in BMI was 2.9 kg/m2 and
1.3kg/m2, respectively (P,0.001).
In general, the proportion of male and female patients
achieving weight loss after treatment with lorcaserin DE
was similar: 43.9% of male and 47.8% of female patients
12
achieved a weight loss of $5% compared with 23.6% of

males and 22.4% of female patients in the placebo DE group
(MITT population). When the MITT population was analyzed
according to race, 53.1% of white (Caucasian), 50.0% of
Asian, 34.7% of black (African American), and 31.6% of
Hispanic patients achieved a weight loss of $5% after
treatment with lorcaserin DE compared with 25.9% of white,

22.2% of Asian, 14.6% of black, and 17.7% of Hispanic

patients in the placebo DE group. The mean weight loss
( standard deviation) in the pooled MITT population
stratified by ethnicity was 6.64kg ( 0.15kg) in white,
5.48kg ( 1.12kg) in Asian, 3.97kg ( 0.22kg) in black,
and 3.49kg ( 0.28kg) in Hispanic patients treated with
lorcaserin DE compared with 3.06kg ( 0.14kg) in white,
2.62kg ( 1.13kg) in Asian, 1.21kg ( 0.17kg) in black,
and 1.49kg ( 0.22kg) in Hispanic patients treated with
placebo DE. For both sex and race analyses, similar trends
were seen for patients achieving a weight loss of $10% in the
lorcaserin DE group versus the placebo DE group. Although
categorical $5% and $10% weight losses were less for lorcaserin DE in the black and Hispanic populations compared
with the white and Asian populations, this was matched by
smaller responses in the placebo DE subpopulations. Ethnic
differences in response appear to be because of a reduced
effectiveness in the standardized lifestyle modification program and not because of differences in response to lorcaserin.
Pooled Secondary Analyses

Lipid Parameters
Patients in the lorcaserin DE group showed greater improvements in lipid parameters than those in the placebo DE group
(Figure3). In the MITT population, there was a statistically
significant change (P#0.001) from baseline in TG, TC, and
HDL-C at week 52in the lorcaserin DE group compared
with placebo DE (TG, 5.2% vs 0.6%; TC, 0.8% vs 0.4%;
HDL-C, 1.8% vs 0.6%, respectively). Patients receiving lorcaserin DE in the MITT population also had a significantly
lower mean increase in LDL compared with those receiving
placebo DE (1.6% vs 3.0%, respectively; P=0.015). Analysis
of patients in the completer population showed statistically
significant changes (P,0.001) from baseline in TG, TC, and
HDL-C levels at week 52in the lorcaserin DE group compared with placebo DE (TG, 10.5% vs 3.5%; TC, 1.2%
vs 0.5%; HDL-C, 2.8% vs 1.0%; respectively). Completers
in the lorcaserin DE group also showed a significantly lower
mean increase in LDL compared with the placebo DE group
(1.7% vs 3.8%; P,0.008).
significant decrease from baseline in HbA1c values at week

52in the lorcaserin DE group (0.11%) compared with
placebo DE (0.05%; P ,0.001) in the MITT population (Figure4A). Also in the same population, there was
a statistically significant decrease from baseline in fasting
plasma glucose levels at week 52in the lorcaserin DE group
(0.2%) versus placebo DE (0.5%; P,0.001; Figure4B).
This pattern was also seen in the completer population for
both HbA1c (lorcaserin DE, 0.14%; placebo DE, 0.06%;
P,0.001; Figure4A) and fasting plasma glucose (lorcaserin
DE, 3.1%; placebo DE, 1.7%; P,0.001; Figure4B).
Vital Signs
Numerical decreases in heart rate and blood pressure were
observed in the lorcaserin DE and placebo DE groups. Mean
decreases in the lorcaserin DE group were statistically greater
for both systolic (lorcaserin DE, 1.73mmHg; placebo
DE, 1.05mmHg; P=0.007) and diastolic (lorcaserin DE,
1.50mmHg; placebo DE, 1.04mmHg; P=0.003) blood
pressure in the MITT population; this effect was also seen
in the completer population (P ,0.001 for systolic and
diastolic measurements). The mean decrease in heart rate
was greater in the lorcaserin DE group versus the placebo
DE group (1.57 vs 0.29 beats per minute, respectively;
safety population). Although variations in heart rate were
seen from week to week, patients in the lorcaserin DE group
had consistently lower heart rates.
Quality of Life
After 52 weeks of treatment, a significantly greater increase

in the IWQOL-Lite total score for the MITT population
was measured in the lorcaserin DE group (lorcaserin DE,
12.01; placebo DE, 10.09; P,0.001), indicating a greater
improvement in quality of life; this improvement was seen
across all subcategories of the IWQOL-Lite (P,0.001).
A significant improvement in IWQOL-Lite total score was
also seen in the completer population (lorcaserin DE, 12.80;
placebo DE, 11.15; P,0.001).
Pooled Safety Analyses

Adverse Events
Glycemic Parameters
Although the presence of diabetes was exclusionary in the
BLOOM and BLOSSOM trials and mean baseline HbA1c
values were within the normal range in both treatment groups
(Table1), improvements in glycemic indicators were consistently more favorable in lorcaserin DEtreated patients than
in those treated with placebo DE. There was a statistically
In an analysis of the safety population, 2645 patients (82.8%)

in the lorcaserin DE group experienced adverse events
(AEs) compared with 2406 patients (75.5%) in the placebo
DE group. The most common AEs occurring at numerically
different rates for both groups were headache (lorcaserin
DE, 16.8%; placebo DE, 10.1%), upper respiratory tract
infection (lorcaserin DE, 13.7%; placebo DE, 12.3%), and
Aronne etal

Figure3. The effect of lorcaserin treatment on lipid parameters. Mean percentage change from baseline in triglycerides, total cholesterol, LDL cholesterol, and HDL
cholesterol at week 52.
*P,0.05.
**P#0.001.
Abbreviations: completers, completer population; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MITT, modified intention-to-treat; SE, standard error.
nasopharyngitis (lorcaserin DE, 13.0%; placebo DE, 12.0%)

(Table2). The overall rates of serious AEs (SAEs) were similar between the lorcaserin DE (2.7%) and placebo DE (2.3%)
groups. Very few treatment-related SAEs were reported in
either treatment group: 9 patients (0.3%) in the lorcaserin DE
and 6 patients (0.2%) in the placebo DE groups experienced
treatment-related SAEs. No treatment-related SAEs of the
same Medical Dictionary for Regulatory Activities preferred
term were reported by.1 patient in each group.
Discontinuations
Pooled phase III data indicate that 1398 patients (43.7%)
in the lorcaserin DE group were withdrawn from the studies before week 52 versus 1640 (51.4%) in the placebo DE
group. The most common reasons for discontinuation were
withdrawal of consent (lorcaserin DE, 18.8%; placebo DE,
25.5%) and lost to follow-up (lorcaserin DE, 12.2%; placebo
DE, 14.4%). Discontinuations due to AEs were slightly more
frequent in the lorcaserin DE group than in the placebo DE
group (8.6% and 6.8% in the safety population, respectively). Only headache was associated with a discontinuation rate.1%, with 1.3% of patients in the lorcaserin DE
14
group versus 0.8% in the placebo DE group discontinuing

from the study.
Valvular Heart Disease

Analysis of echocardiogram data (N=4830; pooled safety
population) indicates that lorcaserin treatment has a rate of
FDA-defined valvulopathy similar to placebo. The weighted
difference in the proportion of patients that developed
echocardiographic criteria for FDA-defined valvulopathy
at week 52in the lorcaserin DE and placebo DE groups
(2.33% vs 2.18%, respectively) was 0.15% (90% CI, 0.55
to 0.85), and the calculated relative risk was 1.07 (90% CI,
0.78 to 1.46). No excess risk for FDA-defined valvulopathy
was evident in an analysis of patients who completed the
full 52-week dosing period. The weighted difference in
the proportion of completers that developed FDA-defined
valvulopathy at week 52 for the lorcaserin DE (N=1710)
and placebo DE (N=1488) groups (2.46% vs 2.69%,
respectively) was 0.27% (90% CI, 1.19 to 0.64), and the
calculated relative risk was 0.90 (90% CI, 0.63 to 1.29).
There was no significant difference between the lorcaserin
DE and placebo DE groups in the mean change from baseline

Figure4. The effect of lorcaserin treatment on glycemic indicators. (A) Mean percentage change from baseline in HbA1c, and (B) change from baseline in fasting plasma
glucose at week 52.
*P,0.001.
Abbreviations: completers, completer population; HbA1c, hemoglobin A1c; MITT, modified intention-to-treat; SE, standard error.
for estimated pulmonary artery systolic pressures at week 52

(0.16mmHg [0.30 vs 0.46mmHg, respectively]; 95% CI,
0.20 to 0.52).
Discussion
Pooled analysis of the BLOOM and BLOSSOM trials shows

that lorcaserin treatment in combination with DE results in
a clinically meaningful weight loss compared with placebo

DE in adults without diabetes who are overweight or obese.
At week 52, patients in the MITT population treated with
lorcaserin DE were twice as likely to achieve a weight loss
of $5% compared with placebo DE (47.1% vs 22.6%,
respectively; P ,0.001). Additionally, those treated with
lorcaserin DE were also almost 3 times as likely to achieve
Aronne etal

Table 2. Adverse Events Occurring in $ 3% of the Pooled

BLOOM and BLOSSOM Patients (Safety Population)
Preferred Term,
n (%)
Placebo
(N = 3185)
Lorcaserin,
10 mg BID
(N = 3195)
Headache
Upper respiratory tract infection
Nasopharyngitis
Dizziness
Nausea
Sinusitis
Fatigue
Urinary tract infection
Diarrhea
Back pain
Constipation
Dry mouth
Arthralgia
Influenza
Cough
Gastroenteritis viral
Vomiting
Oropharyngeal pain
Bronchitis
Pain in extremity
Muscle strain
Insomnia
321 (10.1)
391 (12.3)
381 (12.0)
122 (3.8)
170 (5.3)
245 (7.7)
114 (3.6)
171 (5.4)
179 (5.6)
178 (5.6)
125 (3.9)
74 (2.3)
150 (4.7)
134 (4.2)
109 (3.4)
101 (3.2)
83 (2.6)
80 (2.5)
105 (3.3)
95 (3.0)
74 (2.3)
97 (3.0)
537 (16.8)
439 (13.7)
414 (13.0)
270 (8.5)
264 (8.3)
236 (7.4)
229 (7.2)
207 (6.5)
207 (6.5)
201 (6.3)
186 (5.8)
169 (5.3)
149 (4.7)
138 (4.3)
136 (4.3)
137 (4.3)
122 (3.8)
111 (3.5)
104 (3.3)
99 (3.1)
98 (3.1)
81 (2.5)
Abbreviations: BID, twice daily; BLOOM, Behavioral Modification and Lorcaserin

for Overweight and Obesity Management; BLOSSOM, Behavioral Modification and
Lorcaserin Second Study for Obesity Management.
a $10% weight loss (22.4% vs 8.7%) and achieved a greater

percentage weight loss (5.8% vs 2.5%). The proportion
who achieved a weight loss of $5% was even greater in
the population who remained on therapy for the full year
(completer population) compared with the MITT population, with nearly two-thirds (63.9%) of the lorcaserin-treated
completers achieving a weight loss of $5% and one-third
(34.7%) achieving a weight loss of $10%.
Unrealistic weight loss goals often cause patients to discontinue weight loss treatment.21 However, physicians can
help patients understand that even a modest loss in weight
can improve health and minimize complications associated
with obesity, such as type 2 diabetes mellitus and hypertension.22 Two seminal studies, one by the Diabetes Prevention
Program and the other by the Finnish Diabetes Prevention
Study, showed that moderate weight loss (5%7% of body
weight) and moderate increases in physical activity in patients
who are prediabetic significantly reduced the incidence of
type 2 diabetes.23,24 In the Diabetes Prevention Program a 7%
weight loss reduced the risk of developing new type 2 diabetes by 58%. Similarly, modest weight loss has consistently
been shown to decrease blood pressure.23,2527
16
Increased fat in the abdominal region is associated with

health risks including cardiovascular disease and type 2
diabetes.28 Therefore, monitoring changes in waist circumference over time can provide a useful measure of patient
health.22,28 Men are at an increased risk of cardiovascular
disease and other obesity-related comorbidities if they have a
waist circumference.40inches (102cm); whereas women
with waist circumference.35inches (88cm) are at an
increased risk.22 Patients treated with lorcaserin in addition to
DE had a significantly greater reduction in waist circumference compared with those treated with DE alone.
In this pooled analysis, independent predictors of cardiovascular risk, such as lipids and glycemic indicators,
improved significantly with lorcaserin treatment. Improvements in TG, TC, and HDL-C were greater in the lorcaserin
group than in the placebo group, and a smaller increase in
LDL-C was observed compared with placebo. Increases
in LDL-C have been seen after weight loss in those who
adhere to a low-carbohydrate diet and those with other
dietary interventions, such as omega-3 fatty acids as a result
of increased conversion of very low-density lipoprotein to
LDL.2931 Lorcaserin-treated patients also experienced greater
reductions in glycemic indicators compared with placebo.
This pooled analysis confirms the findings from the BLOOM
and BLOSSOM trials.15,16
The 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the
American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity
Society provides guidance to physicians regarding the use
of comprehensive lifestyle modification with adjunctive
therapies for adults who are overweight or obese, depending
on the particular needs of the patient.22 Several therapeutic
approaches to weight loss can be used, either separately or in
combination, including caloric restriction, increased physical
activity, behavioral modification, anti-obesity pharmacotherapy, and surgery.22 Anti-obesity drugs, such as lorcaserin, in
combination with DE are an effective intervention that PCPs
can use to treat adults who are overweight or obese. In this
pooled analysis, the addition of lorcaserin to DE consistently
outperformed DE alone; greater improvements were observed
in those completing 1 year of therapy.
The hesitancy for PCPs to use pharmacological agents in
the treatment of obesity may be because of concerns related
to adverse cardiovascular events, such as those associated
with the fenfluramines and sibutramine.32,33 The present
analysis shows that lorcaserin has a favorable safety profile for extended use of $1 year. The most common side

effects associated with lorcaserin use were headache, upper

respiratory tract infection, and nasopharyngitis, and very few
patients discontinued use for these reasons. The incidence
of echocardiographically defined valvulopathy was not
increased with lorcaserin use, and there was no significant
difference in the mean change in estimated pulmonary artery
systolic pressure. This is consistent with the complete phase
III safety program (BLOOM, BLOSSOM, and BLOOM-DM
trials), in which.20 000 echocardiograms during 2 years of
lorcaserin exposure showed that lorcaserin was noninferior to
placebo with respect to incidence of new FDA-defined valvulopathy. Furthermore, lorcaserin-treated patients exhibited
decreases in both heart rate and blood pressure compared with
placebo-treated patients. This is a positive effect on vascular
safety seen with lorcaserin, in contrast to the sympathomimetic effects seen with sibutramine use.33
Another misconception shared by many practitioners
is that willpower is necessary for successful weight loss.34
Data suggest, however, that during calorie restriction, energy
expenditure decreases and appetite increases.4,35 Changes
in the homeostatic regulation of body weight persist for
$12months, even after the onset of weight regain, suggesting that the difficulty of losing weight and the likelihood of
weight regain have a strong physiologic basis and are not
simply the result of resumption of previous habits.4 Adding
lorcaserin as an adjunct to DE may help offset this increase
in appetite, resulting in additional weight loss.13
Limitations of the current analysis include those described
for the BLOOM and BLOSSOM trials.15,16 Specifically, there
was a withdrawal rate of almost 50% at 1 year, which is not
uncommon in obesity trials.15,36,37 However, rates of withdrawal were higher in the placebo DE group (51.4%) than the
lorcaserin DE group (43.7%). Withdrawal because of protocol
deviation/noncompliance, principal investigator or sponsor
decision, or for other reasons were distributed fairly equally
across the treatment groups, although more patients in the
lorcaserin DE than the placebo DE group withdrew for AEs
(7.1% vs 5.6%), and slightly more patients in the placebo DE
group withdrew consent or were lost to follow-up.
Conclusions
This pooled phase III analysis of the BLOOM and BLOSSOM trials, the largest obesity trial dataset published to date
within the US, shows that lorcaserin 10mg, twice daily, in
combination with DE versus placebo in combination with
DE is associated with statistically significant weight loss.
Furthermore, improvements in cardiometabolic parameters
show that weight loss associated with lorcaserin use is
clinically relevant.
Acknowledgments
Editorial support was provided by Imprint Publication Science, New York, NY, and was funded by Eisai Inc. These
studies were funded by Arena Pharmaceuticals Inc.
Conflict of Interest Statement
Randi Fain, MD, William Soliman, PhD, and Yuhan Li, MS,
are employees of Eisai Inc. William Shanahan, MD, and Alan
Glicklich, MD, are employees of Arena Pharmaceuticals
Inc. Steven Smith, MD, has served as a paid consultant to
Arena Pharmaceuticals, Eisai Inc., and to other companies.
Louis Aronne, MD, has served as a paid consultant to Arena
Pharmaceuticals, Eisai Inc., Pfizer, GI Dynamics, Aspire,
Vivus, and Ethicon, and holds shares in Zafgen, MYOS
Corporation, and BMIQ.
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Safety and Efficacy of Lorcaserin: A Combined Analysis of The BLOOM and BLOSSOM Trials

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Safety and Efficacy of Lorcaserin: A Combined Analysis of The BLOOM and BLOSSOM Trials

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C L I N I C A L F O C U S : M E TA B O L I C S Y N D R O M E , D I A B E T E S , A N D I M M U N I Z AT I O N S

Safety and Efficacy of Lorcaserin: A Combined

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Background: Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the US

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Calorie restriction results in a rapid and profound

intake rather than altering energy expenditure.13 Lorcaserin is

Materials and Methods

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Combined Analysis of the BLOOM and BLOSSOM Trials

inclusion criteria for both studies were age 18 to 65years

Co-primary end points included evaluation at week 52 with

from baseline to week 52.15,16 Differences in incidence were

Patient groups discussed in this analysis include the modified

The pooled safety population includes 3195 patients treated

Pooled Primary Analysis

Pooled data from the BLOOM and BLOSSOM trials included

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Combined Analysis of the BLOOM and BLOSSOM Trials

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

patient population, lorcaserin DE was superior to placebo

received lorcaserin DE had a higher mean percentage of

Figure1. Patient randomization and disposition in the pooled population.

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

circumference was 8.2cm and 5.0cm for the lorcaserin

achieved a weight loss of $5% compared with 23.6% of

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Combined Analysis of the BLOOM and BLOSSOM Trials

22.2% of Asian, 14.6% of black, and 17.7% of Hispanic

Pooled Secondary Analyses

significant decrease from baseline in HbA1c values at week

After 52 weeks of treatment, a significantly greater increase

Pooled Safety Analyses

In an analysis of the safety population, 2645 patients (82.8%)

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

nasopharyngitis (lorcaserin DE, 13.0%; placebo DE, 12.0%)

group versus 0.8% in the placebo DE group discontinuing

Valvular Heart Disease

Combined Analysis of the BLOOM and BLOSSOM Trials

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

for estimated pulmonary artery systolic pressures at week 52

Pooled analysis of the BLOOM and BLOSSOM trials shows

a clinically meaningful weight loss compared with placebo

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Table 2. Adverse Events Occurring in $ 3% of the Pooled

Abbreviations: BID, twice daily; BLOOM, Behavioral Modification and Lorcaserin

a $10% weight loss (22.4% vs 8.7%) and achieved a greater

Increased fat in the abdominal region is associated with

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

Combined Analysis of the BLOOM and BLOSSOM Trials

effects associated with lorcaserin use were headache, upper

Conflict of Interest Statement

Postgraduate Medicine Downloaded from informahealthcare.com by Nyu Medical Center on 07/12/15

26. Wassertheil-Smoller S, Blaufox MD, Oberman AS, Langford HG,

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