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Randomized Controlled Trial
.2018 Feb;8(1):1-10.
doi: 10.1111/cob.12226. Epub 2017 Oct 16.

Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity

Affiliations
Randomized Controlled Trial

Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity

R L Kolotkin et al. Clin Obes.2018 Feb.

Abstract

Previously in the SCALE Obesity and Prediabetes trial, at 1 year, participants with obesity (or overweight with comorbidities) and prediabetes receiving liraglutide 3.0 mg experienced greater improvements in health-related quality of life (HRQoL) than those receiving placebo. The current study extends these findings by examining 3-year changes in HRQoL. HRQoL was assessed using the obesity-specific Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, as well as the Short-Form 36 v2 (SF-36) health survey. At 3 years, mean change (±standard deviation) in IWQOL-Lite total score from baseline for liraglutide (n = 1472) was 11.0 ± 14.2, vs. 8.1 ± 14.7 for placebo (n = 738) (estimated treatment difference [ETD] 3.4 [95% confidence interval (CI): 2.0, 4.7], P < 0.0001). Mean change in SF-36 physical component summary (PCS) score from baseline for liraglutide was 3.1 ± 7.3, vs. 2.6 ± 7.6 for placebo (ETD 0.87 [95% CI: 0.17, 1.6], P = 0.0156). Mean change in SF-36 mental component summary score did not significantly differ between groups. Both IWQOL-Lite total score and PCS score demonstrated an association between greater HRQoL improvement with higher weight loss. Liraglutide 3.0 mg was also associated with improved health utility (Short-Form-6D and EuroQol-5D, mapped from IWQOL-Lite and/or SF-36) vs. placebo. Liraglutide 3.0 mg, plus diet and exercise, is associated with long-term improvements in HRQoL with obesity or overweight with comorbidity vs. placebo.

Keywords: IWQOL-Lite; SF-36 v2; liraglutide 3.0 mg; weight loss.

© 2017 The Authors. Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

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Figures

Figure 1
Figure 1
Total IWQOL‐Lite (a) and SF‐36 PCS (b) and MCS (c) scores over time. Full analysis set, observed values for participants with HRQoL data; values are means ± SE. HRQoL, health‐related quality of life; IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite; MCS, mental component summary; PCS, physical component summary; SE, standard error; SF‐36, Short‐Form 36 v2.
Figure 2
Figure 2
IWQOL‐Lite ETD for total and subscale scores at 3 years. Change in score is the estimated mean change from baseline to Week 160; ETD, ; right panel shows estimated treatment difference ± 95% confidence intervals; missing data are imputed using last observation carried forward. The data are analysed using analysis of covariance (ancova) with treatment, country, gender, BMI stratification groups (<30, ≥30 kg m−2) as fixed factors, and baseline HRQoL scores (at Week 0) as covariates. BMI, body mass index; ETD, estimated treatment difference; HRQoL, health‐related quality of life; IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite.
Figure 3
Figure 3
Proportion of subjects with meaningful estimated mean change from baseline to 3 years in HRQoL for IWQOL‐Lite total score and SF‐36 summary scores. Meaningful estimated mean change from baseline to Week 160 (LOCF) was defined differently for the IWQOL‐Lite and the SF‐36 according to published algorithms. The data was analysed in an ordinal regression using a cumulative logit link. The model includes treatment, sex, country, BMI stratification factor as fixed factors and the baseline HRQoL score (IWQOL‐Lite total score, SF‐36 PCS score or SF‐36 MCS score, as appropriate) as a covariate. Graphs are estimated proportions. OR for response classes was calculated as the ratio of results from participants receiving liraglutide 3.0 mg and placebo. BMI, body mass index, CI, confidence interval; HRQoL, health‐related quality of life; IWQOL‐Lite, Impact of Weight on Quality of Life‐Lite, LOCF, last observation carried forward; MCS, mental component summary; OR, odds ratio; PCS, physical component summary; SF‐36, Short‐Form 36 v2.
Figure 4
Figure 4
SF‐36 ETD for physical component summary, mental component summary and subscale scores at 3 years. Change in score is the estimated mean change from baseline to Week 160; ETD; right panel shows estimated treatment difference ± 95% confidence intervals; missing data are imputed using last observation carried forward. The data are analysed using analysis of covariance (ancova) with treatment, country, gender, BMI stratification groups (<30, ≥30 kg m−2) as fixed factors, and baseline HRQoL scores (at Week 0) as covariates. BMI, body mass index; ETD, estimated treatment difference; SF‐36, Short‐Form 36 v2.
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References

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