In the JournalsPerspective

SCALE: Liraglutide increases health-related quality of life in obesity, prediabetes

Ronette Kolotkin
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.

Ronette L. 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

For more information:

Ronette L. Kolotkin, PhD, can be reached at rkolotkin@qualityoflifeconsulting.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.

Ronette Kolotkin
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.

Ronette L. 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

For more information:

Ronette L. Kolotkin, PhD, can be reached at rkolotkin@qualityoflifeconsulting.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.

    Perspective

    Cherie Lisa Vaz

    This large multi-site, randomized, placebo-controlled clinical trial was well powered to provide high-quality evidence from its findings after 3 years. Study participants were predominantly white women, but were well balanced demographically and by baseline characteristics in both groups. The study intervention, liraglutide 3 mg plus lifestyle modification, was successful at maintaining weight loss at 3 years — an unusual and encouraging outcome for a medical weight-loss intervention. A key positive outcome of this study was the prevention of weight gain in 85% of participants receiving liraglutide compared with 62% in the placebo group after 3 years. Having a treatment modality, other than bariatric surgery, which can help keep weight off beyond 1 year is a nice addition to our toolbox for long term weight management. In clinical practice, all patients who could benefit from weight loss should receive counseling on lifestyle modification for weight loss with the hope of improving their health and quality of life. The long-term weight loss seen in this study after 3 years translated into a sustained improvement in the physical aspects of health-related quality of life and weight-related quality of life, both clinically meaningful outcomes. A caveat of this study was that, except for the highest weight-loss category (> 15% weight loss), all other weight-loss categories showed some decline in the mental component of health-related quality of life. This continues our mission to prevent obesity and develop new treatments capable of larger, long-term weight loss in order to achieve both physical and psychological benefits for our patients.

    Cherie Lisa Vaz MD, Dipl. ABOM

    Assistant Professor of Medicine
    Section of Endocrinology, Diabetes and Metabolism
    Temple University, Lewis Katz School of Medicine

    Disclosure: Vaz reports no relevant financial disclosures.