IMPROVEMENTS IN HEALTH-RELATED QUALITY OF LIFE WITH LIRAGLUTIDE 3.0 MG COMPARED WITH PLACEBO FOR WEIGHT MANAGEMENT
AACE ePoster Library. Kolotkin R. 05/13/15; 97767; 610
Ronette Kolotkin
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Abstract
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Objective: Obesity has a negative impact on health-related quality of life
(HRQoL), the degree of which is dependent upon the severity of obesity.
The Satiety and Clinical Adiposity - Liraglutide Evidence (SCALE) Obesity
and Prediabetes study aimed to investigate the effect of liraglutide 3.0 mg,
as adjunct to diet and exercise, on HRQoL in non-diabetic obese or
overweight subjects, with or without pre-diabetes.
Methods: Individuals (BMI ≥27 kg/m with ≥1 comorbidity or ≥30 kg/m )
were advised on a 500 kcal/day deficit diet and a 150 min/week exercise
program, and randomized 2:1 to once-daily s.c. liraglutide 3.0 mg (n=2487)
or placebo (n=1244). HRQoL outcomes, assessed in subjects from
countries with validated translations (82% of randomized) at baseline, 6
months and 1 year (end of trial), utilized Impact of Weight on Quality of
Life-Lite (IWQOL-Lite) and Short-Form 36 v2 (SF-36) questionnaires. The
Treatment-Related Impact Measure-Weight (TRIM-Weight) was completed
at 6 months and end of trial. Data were reported as observed means±SD
and estimated treatment differences (ED), derived using ANCOVA with
LOCF.
Results or Case Presentation: Baseline characteristics: 78.5% female,
age 45.1 years, weight 106.2 kg, BMI 38.3 kg/m (all means). Individuals on
liraglutide 3.0 mg had significantly greater improvements in IWQOL-Lite total
score [(10.6±13.3) vs. placebo (7.6±12.8; ED 3.1 [95%CI: 2.2;4.0];
p<0.0001)] and SF-36 physical (PCS) and mental component (MCS)
summary scores (PCS, 3.6±6.8; MCS, 0.2±8.1) vs. placebo (PCS, 2.2±7.7;
MCS, -0.9±9.1) (ED PCS 1.7 [95%CI: 1.2;2.2], p<0.0001; and MCS 0.9
[95%CI: 0.3;1.5, p=0.003]), which accompanied greater weight loss from
baseline (-8.0±6.7%) compared with placebo (-2.6±5.7%; ED -5.4%
[95%CI: -5.8;-5.0]; p<0.0001)). All sub-domain scores of the IWQOL-Lite
and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo.
Odds of achieving a minimally clinically important improvement were higher
with liraglutide 3.0 mg vs. placebo for IWQOL-Lite total score (1.59
[1.35;1.88], p<0.001) and SF-36 PCS (1.69 [1.43; 2.00] p<0.0001). The
TRIM-Weight total score was also higher at end of trial with liraglutide 3.0
mg (83.1±10.7) vs. placebo (81.0±9.4; ED 2.1 [95%CI: 1.3;3.0], p<0.0001).
Discussion: Use of liraglutide 3.0 mg, in addition to diet and exercise, was
associated with clinically meaningful improvements in physical domains of
HRQoL vs. placebo.
Conclusion: Treatment with liraglutide 3.0 mg significantly improves
HRQoL, including physical function and mental health, in patients who are
overweight or have obesity, compared with placebo.
(HRQoL), the degree of which is dependent upon the severity of obesity.
The Satiety and Clinical Adiposity - Liraglutide Evidence (SCALE) Obesity
and Prediabetes study aimed to investigate the effect of liraglutide 3.0 mg,
as adjunct to diet and exercise, on HRQoL in non-diabetic obese or
overweight subjects, with or without pre-diabetes.
Methods: Individuals (BMI ≥27 kg/m with ≥1 comorbidity or ≥30 kg/m )
were advised on a 500 kcal/day deficit diet and a 150 min/week exercise
program, and randomized 2:1 to once-daily s.c. liraglutide 3.0 mg (n=2487)
or placebo (n=1244). HRQoL outcomes, assessed in subjects from
countries with validated translations (82% of randomized) at baseline, 6
months and 1 year (end of trial), utilized Impact of Weight on Quality of
Life-Lite (IWQOL-Lite) and Short-Form 36 v2 (SF-36) questionnaires. The
Treatment-Related Impact Measure-Weight (TRIM-Weight) was completed
at 6 months and end of trial. Data were reported as observed means±SD
and estimated treatment differences (ED), derived using ANCOVA with
LOCF.
Results or Case Presentation: Baseline characteristics: 78.5% female,
age 45.1 years, weight 106.2 kg, BMI 38.3 kg/m (all means). Individuals on
liraglutide 3.0 mg had significantly greater improvements in IWQOL-Lite total
score [(10.6±13.3) vs. placebo (7.6±12.8; ED 3.1 [95%CI: 2.2;4.0];
p<0.0001)] and SF-36 physical (PCS) and mental component (MCS)
summary scores (PCS, 3.6±6.8; MCS, 0.2±8.1) vs. placebo (PCS, 2.2±7.7;
MCS, -0.9±9.1) (ED PCS 1.7 [95%CI: 1.2;2.2], p<0.0001; and MCS 0.9
[95%CI: 0.3;1.5, p=0.003]), which accompanied greater weight loss from
baseline (-8.0±6.7%) compared with placebo (-2.6±5.7%; ED -5.4%
[95%CI: -5.8;-5.0]; p<0.0001)). All sub-domain scores of the IWQOL-Lite
and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo.
Odds of achieving a minimally clinically important improvement were higher
with liraglutide 3.0 mg vs. placebo for IWQOL-Lite total score (1.59
[1.35;1.88], p<0.001) and SF-36 PCS (1.69 [1.43; 2.00] p<0.0001). The
TRIM-Weight total score was also higher at end of trial with liraglutide 3.0
mg (83.1±10.7) vs. placebo (81.0±9.4; ED 2.1 [95%CI: 1.3;3.0], p<0.0001).
Discussion: Use of liraglutide 3.0 mg, in addition to diet and exercise, was
associated with clinically meaningful improvements in physical domains of
HRQoL vs. placebo.
Conclusion: Treatment with liraglutide 3.0 mg significantly improves
HRQoL, including physical function and mental health, in patients who are
overweight or have obesity, compared with placebo.
Objective: Obesity has a negative impact on health-related quality of life
(HRQoL), the degree of which is dependent upon the severity of obesity.
The Satiety and Clinical Adiposity - Liraglutide Evidence (SCALE) Obesity
and Prediabetes study aimed to investigate the effect of liraglutide 3.0 mg,
as adjunct to diet and exercise, on HRQoL in non-diabetic obese or
overweight subjects, with or without pre-diabetes.
Methods: Individuals (BMI ≥27 kg/m with ≥1 comorbidity or ≥30 kg/m )
were advised on a 500 kcal/day deficit diet and a 150 min/week exercise
program, and randomized 2:1 to once-daily s.c. liraglutide 3.0 mg (n=2487)
or placebo (n=1244). HRQoL outcomes, assessed in subjects from
countries with validated translations (82% of randomized) at baseline, 6
months and 1 year (end of trial), utilized Impact of Weight on Quality of
Life-Lite (IWQOL-Lite) and Short-Form 36 v2 (SF-36) questionnaires. The
Treatment-Related Impact Measure-Weight (TRIM-Weight) was completed
at 6 months and end of trial. Data were reported as observed means±SD
and estimated treatment differences (ED), derived using ANCOVA with
LOCF.
Results or Case Presentation: Baseline characteristics: 78.5% female,
age 45.1 years, weight 106.2 kg, BMI 38.3 kg/m (all means). Individuals on
liraglutide 3.0 mg had significantly greater improvements in IWQOL-Lite total
score [(10.6±13.3) vs. placebo (7.6±12.8; ED 3.1 [95%CI: 2.2;4.0];
p<0.0001)] and SF-36 physical (PCS) and mental component (MCS)
summary scores (PCS, 3.6±6.8; MCS, 0.2±8.1) vs. placebo (PCS, 2.2±7.7;
MCS, -0.9±9.1) (ED PCS 1.7 [95%CI: 1.2;2.2], p<0.0001; and MCS 0.9
[95%CI: 0.3;1.5, p=0.003]), which accompanied greater weight loss from
baseline (-8.0±6.7%) compared with placebo (-2.6±5.7%; ED -5.4%
[95%CI: -5.8;-5.0]; p<0.0001)). All sub-domain scores of the IWQOL-Lite
and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo.
Odds of achieving a minimally clinically important improvement were higher
with liraglutide 3.0 mg vs. placebo for IWQOL-Lite total score (1.59
[1.35;1.88], p<0.001) and SF-36 PCS (1.69 [1.43; 2.00] p<0.0001). The
TRIM-Weight total score was also higher at end of trial with liraglutide 3.0
mg (83.1±10.7) vs. placebo (81.0±9.4; ED 2.1 [95%CI: 1.3;3.0], p<0.0001).
Discussion: Use of liraglutide 3.0 mg, in addition to diet and exercise, was
associated with clinically meaningful improvements in physical domains of
HRQoL vs. placebo.
Conclusion: Treatment with liraglutide 3.0 mg significantly improves
HRQoL, including physical function and mental health, in patients who are
overweight or have obesity, compared with placebo.
(HRQoL), the degree of which is dependent upon the severity of obesity.
The Satiety and Clinical Adiposity - Liraglutide Evidence (SCALE) Obesity
and Prediabetes study aimed to investigate the effect of liraglutide 3.0 mg,
as adjunct to diet and exercise, on HRQoL in non-diabetic obese or
overweight subjects, with or without pre-diabetes.
Methods: Individuals (BMI ≥27 kg/m with ≥1 comorbidity or ≥30 kg/m )
were advised on a 500 kcal/day deficit diet and a 150 min/week exercise
program, and randomized 2:1 to once-daily s.c. liraglutide 3.0 mg (n=2487)
or placebo (n=1244). HRQoL outcomes, assessed in subjects from
countries with validated translations (82% of randomized) at baseline, 6
months and 1 year (end of trial), utilized Impact of Weight on Quality of
Life-Lite (IWQOL-Lite) and Short-Form 36 v2 (SF-36) questionnaires. The
Treatment-Related Impact Measure-Weight (TRIM-Weight) was completed
at 6 months and end of trial. Data were reported as observed means±SD
and estimated treatment differences (ED), derived using ANCOVA with
LOCF.
Results or Case Presentation: Baseline characteristics: 78.5% female,
age 45.1 years, weight 106.2 kg, BMI 38.3 kg/m (all means). Individuals on
liraglutide 3.0 mg had significantly greater improvements in IWQOL-Lite total
score [(10.6±13.3) vs. placebo (7.6±12.8; ED 3.1 [95%CI: 2.2;4.0];
p<0.0001)] and SF-36 physical (PCS) and mental component (MCS)
summary scores (PCS, 3.6±6.8; MCS, 0.2±8.1) vs. placebo (PCS, 2.2±7.7;
MCS, -0.9±9.1) (ED PCS 1.7 [95%CI: 1.2;2.2], p<0.0001; and MCS 0.9
[95%CI: 0.3;1.5, p=0.003]), which accompanied greater weight loss from
baseline (-8.0±6.7%) compared with placebo (-2.6±5.7%; ED -5.4%
[95%CI: -5.8;-5.0]; p<0.0001)). All sub-domain scores of the IWQOL-Lite
and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo.
Odds of achieving a minimally clinically important improvement were higher
with liraglutide 3.0 mg vs. placebo for IWQOL-Lite total score (1.59
[1.35;1.88], p<0.001) and SF-36 PCS (1.69 [1.43; 2.00] p<0.0001). The
TRIM-Weight total score was also higher at end of trial with liraglutide 3.0
mg (83.1±10.7) vs. placebo (81.0±9.4; ED 2.1 [95%CI: 1.3;3.0], p<0.0001).
Discussion: Use of liraglutide 3.0 mg, in addition to diet and exercise, was
associated with clinically meaningful improvements in physical domains of
HRQoL vs. placebo.
Conclusion: Treatment with liraglutide 3.0 mg significantly improves
HRQoL, including physical function and mental health, in patients who are
overweight or have obesity, compared with placebo.
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