Ronette L. Kolotkin
Adults with obesity and prediabetes showed 3-year improvements in health-related quality of life and weight loss with once-daily subcutaneous liraglutide compared with placebo, according to findings published in Clinical Obesity.
The liraglutide 3-mg injection (Saxenda, Novo Nordisk) was approved by the FDA in 2014, and the FDA approved an updated product label earlier this year to include safety and efficacy data from this study.
Kolotkin, PhD, owner of Quality of Life Consulting in Durham, North Carolina, and colleagues evaluated data from the Satiety and Clinical Adiposity – Liraglutide Evidence (SCALE) Obesity and Prediabetes study on adults with obesity and prediabetes randomly assigned to once-daily subcutaneous liraglutide 3 mg (n = 1,505) or placebo (n = 749) for 160 weeks to identify changes in health-related quality of life among them.
Participants were asked to adhere to a 500-kcal per day deficit diet and to complete a 150-minute per week exercise program. Researchers used impact of weight on quality of life (IWQOL)-Lite and SF-36 questionnaires to assess health-related quality-of-life outcomes over 3 years. Endocrine Today previously reported on 1-year health-related quality-of-life outcomes with the use of liraglutide, presented at the American Association of Clinical Endocrinologists Annual Meeting in 2015.
After 3 years, more of the liraglutide group lost at least 15% of weight compared with the placebo group (10.9% vs. 3.1%). Similarly, more of the liraglutide group compared with the placebo group lost 10% to 14.9% (13.8% vs. 6.8%) and 5% to 9.9% (24.7% vs. 13.7%). Weight gain was more likely in the placebo group compared with the liraglutide group (38.6% vs. 14.9%).
Estimated mean change in IWQOL-Lite score was higher in the liraglutide group compared with the placebo group at 3 years (11.1 vs. 7.8; P < .0001). More participants in the liraglutide group compared with the placebo group achieved a maximal IWQOL-Lite score (9.1% vs. 4.6%). The greatest difference between the two groups was observed for the physical function subscale (P < .0001) and significant improvements were achieved in the subscales of self-esteem, sexual life, public distress and work with liraglutide compared with placebo. The liraglutide group was more likely to achieve a meaningful improvement for the IWQOL-Lite score compared with placebo (OR = 1.6; 95% CI, 1.3-2).
Mean change in physical component summary score on the SF-36 was higher in the liraglutide group compared with placebo (3.1 vs. 2.6), whereas there were declines in the mental component summary score at 3 years (–0.46 for liraglutide; –1.4 for placebo). Significant improvements were observed with liraglutide compared with placebo for the following subscales: physical functioning, general health, vitality and mental health. No significant differences were observed between the two groups for physical role functioning, bodily pain, social functioning and emotional role functioning.
“Weight loss is associated with improved patient-reported physical and psychosocial functioning,” Kolotkin told Endocrine Today. “It is important to talk to patients about their quality of life and to include personalized quality-of-life goals in the treatment plan, in addition to weight-loss goals. … Research is needed on longer-term outcomes of weight-loss studies (≥ 5 years) with respect to patient-reported outcomes such as physical function and psychosocial well-being.” – by Amber Cox
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Ronette L. Kolotkin, PhD, can be reached at email@example.com.
Disclosures: Kolotkin reports she has been a consultant to Eisai, Janssen and Novo Nordisk; served on an advisory board and steering committee for Novo Nordisk; and receives royalties from Duke University for the IWQOL-Lite. Please see the study for all other author’ relevant financial disclosures.