New study suggests improvement in quality of life and obesity seen with liraglutide compared with placebo.
Liraglutide (Saxenda) is a glucagon-like peptide-1 (GLP-1) receptor agonist and is approved for weight management in people with obesity or who are overweight. Previously, patients on liraglutide 3.0 mg at 1 year experienced significantly greater improvements in weight loss and health-related quality of life (HRQoL) vs. placebo. This recent study presented 3-year data from the SCALE Obesity and Prediabetes trial. This study is a double-blinded, randomized placebo controlled trial design with a large population that was conducted over 3 years.
The study from Clinical Obesity included participants with prediabetes and either a BMI of ≥30 kg m-2 or a BMI of ≥27 kg m-2 with weight-related conditions of hypertension or dyslipidemia. All of the participants were advised to consume a 500 kcal deficit diet and engage in physical activity for a minimum of 150 minutes/week. Adults with obesity and prediabetes were randomly assigned to once-daily liraglutide 3 mg (n=1505) or placebo (n=749) for 160 weeks to identify changes in health-related quality of life among them.
To assess HRQoL, the IWQOL-Lite and SF-36 v2 health survey were used. The IWQOL-Lite has 31 items and assesses the individual’s perception of impact of weight on quality of life. The SF-36 v2 questionnaire is 36 items and assesses an individual’s general health status using eight subscales.
There were a total of 2,254 participants randomized and included in the prediabetes cohort with a planned duration of 3 years. Of the 1,791 participants, 1,203 had liraglutide and 588 were placebo. Participants were from countries where HRQoL were assessed.
There were a greater proportion of participants who lost weight over 3 years in the liraglutide group compared to the placebo group. The ≥15% weight-loss category included 10.9% of liraglutide participants and 3.1% of the placebo participants (n=23). In the 10-14% weight loss group, 13.8% liraglutide vs. 6.8% placebo and for 5-9% weight loss was 24.7% in liraglutide vs. 13.7% placebo. However, in the 0-5% weight loss group, liraglutide had 35.4% and placebo had 37.3%. In 285 participants on placebo and 219 participants on liraglutide, these patients had weight gain over 3 years.
The results of the IWOQOL-Lite were a greater change from baseline observed for liraglutide vs. placebo. At 3 years, the mean change in IWQOL-Lite total score from baseline for liraglutide was 11.1 vs. 7.8 for placebo. The greatest difference between liraglutide and placebo was in the physical function subscale. For the SF-36 results, the mean change in physical component was higher in the liraglutide group 3.1 score compared with placebo 2.6 score. There were no significant differences between the two groups for physical role functioning, bodily pain, social functioning and emotional role functioning.
Since this study did not have HRQoL as a primary endpoint, they are only exploratory and a limitation to the study. The patient population over 3 years had approximately 50% dropout rate.
In the previous 1-year analysis of the SCALE Obesity and Prediabetes trial, meaningful improvements in HRQoL scores in liraglutide 3.0 mg were shown compared to placebo. This new study adds that durability of changes in HRQoL is important in chronic diseases, whereas improvements in HRQoL in the short term may not be maintained over longer periods. Overall, the 3-year evaluation maintained its scores favoring the liraglutide group over placebo.
There is still more research needed for longer-term outcomes of weight-loss studies with patient reported outcomes for physical function and mental health quality.
- Liraglutide 3 mg had more weight loss than placebo over 3 years.
- Together with diet and exercise, liraglutide is associated with long-term improvements with HRQoL with obesity or overweight with comorbidity vs. placebo.
- This new study shows the durability of liraglutide changes in HRQoL from 1-year to 3-years.
Kolotkin RL, Smolarz BG, Meincke HH, et al. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2017; doi: 10.1111.cob.12226.
Jessica Quach, Doctor of Pharmacy Candidate 2018, GA-PCOM School of Pharmacy