Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management

R L Kolotkin, K Fujioka, M L Wolden, J H Brett, J B Bjorner, R L Kolotkin, K Fujioka, M L Wolden, J H Brett, J B Bjorner

Abstract

Obesity has a negative impact on health-related quality of life (HRQoL). The SCALE Obesity and Prediabetes study investigated the effect of liraglutide 3.0 mg, as adjunct to diet and exercise, on HRQoL in patients with obesity [body mass index (BMI) ≥ 30 kg m(-2) ] or overweight (BMI ≥ 27 kg m(-2) ) with comorbidity. Participants were advised on a 500 kcal d(-1) deficit diet and a 150-min week(-1) exercise programme and were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo. HRQoL was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Short-Form 36 (SF-36) v2 health questionnaires. Individuals on liraglutide 3.0 mg (n = 2046) had significantly greater improvements in IWQOL-Lite total score (10.6 ± 13.3) vs. placebo (n = 1020) (7.7 ± 12.8) and SF-36 physical (PCS) and mental (MCS) component summary scores (PCS, 3.6 ± 6.8; MCS, 0.2 ± 8.1) vs. placebo (PCS, 2.2 ± 7.7; MCS, -0.9 ± 9.1). The estimated treatment differences were IWQOL-Lite total score 3.1 (95% CI: 2.2; 4.0), P < 0.0001; SF-36 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. All subscales of the IWQOL-Lite and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo. More patients on liraglutide 3.0 mg experienced meaningful improvement on the IWQOL-Lite total (P < 0.0001) and the SF-36 PCS (P < 0.0001) scores.

Keywords: IWQOL-Lite; SF-36v2; liraglutide 3.0 mg; quality of life.

© 2016 The Authors. Clinical Obesity published by John Wiley & Sons Ltd on behalf of International Association for the Study of Obesity (IASO).

Figures

Figure 1
Figure 1
IWQOL‐Lite estimated treatment difference for total and subscale scores at Week 56. Data are estimated treatment difference and 95% confidence intervals. *P < 0.0001, †P = 0.0004, ††P = 0.0013, §P = 0.028. IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite.
Figure 2
Figure 2
Meaningful change in HRQoL at Week 56 for IWQOL‐Lite and SF‐36. Meaningful change was defined differently for the IWQOL‐Lite and the SF‐36 according to published algorithms. For the IWQOL‐Lite total score, the cut‐off for 'improvement' and 'deterioration' varied depending on baseline severity40. Cut‐off values are provided in Table S1. For the SF‐36 PCS, 'deterioration' was defined as a change from baseline ≤ −3.8; 'no change' between −3.8 and 3.8; and 'improvement' was a change from baseline ≥3.8. The corresponding values for the MCS were 'deterioration' as change from baseline ≤ −4.6; 'no change’, ‐4.6 and 4.6 and 'improvement' ≥4.6. CI, confidence interval; HRQoL, health‐related quality of life; IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite; MCS, mental component summary; OR, odds ratio; PCS, physical component summary; SF‐36, Short‐Form 36.
Figure 3
Figure 3
SF‐36 estimated treatment difference for PCS and MCS and subscale scores at Week 56. Data are estimated treatment difference and 95% confidence intervals. *P < 0.0001, †P = 0.0034, ‡P = 0.0002, §P = 0.0004. MCS, mental component summary; PCS, physical component summary; SF‐36, Short‐Form 36.
Figure 4
Figure 4
Estimated change in HRQoL score (IWQOL‐Lite total and SF‐36 PCS and MCS) by weight loss category for liraglutide 3.0 mg and placebo. Error bars are standard error. IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite; MCS, mental component summary; PCS, physical component summary; PP, proportion of participants; SF‐36, Short‐Form 36.

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