IMPACT OF WEIGHT LOSS ON PATIENT-REPORTED OUTCOMES IN THE SCALE OBESITY AND PREDIABETES TRIAL OF LIRAGLUTIDE 3.0 MG AS ADJUNCT TO A DIET AND EXERCISE (D&E) PROGRAMME

Author(s)

Kolotkin RL1, Meincke HJ2, Manning LS2, Bjørner JB3
1Quality of Life Consulting, Durham, NJ, USA, 2Novo Nordisk A/S, Søborg, Denmark, 3Optum, Lincoln, RI, USA

OBJECTIVES: To explore impact of weight loss on patient-reported outcomes in individuals without type 2 diabetes, but with obesity (BMI ≥30 kg/m) or overweight (BMI 27.0-29.9 kg/m) with ≥ one comorbidity. Patients were randomised 2:1 to once-daily liraglutide 3.0 mg (n=2487) or placebo (n=1244) as adjunct to D&E. METHODS: Impact of Weight on Quality of Life–Lite (IWQOL-Lite) and Short-Form 36 v2 (SF-36) questionnaires were administered in countries with validated translations (approx. 82% of individuals). Data are reported as estimated change at end-of-trial, derived using ANCOVA with LOCF; increased scores signify improvement. This post hoc analysis was based on categorical weight change from baseline. Results are reported for liraglutide 3.0 mg, placebo respectively, as follows: A = weight gain; B = weight loss 0−4.9%; C = weight loss 5−9.9%; D = weight loss 10−14.9%; E = weight loss ≥15%. RESULTS: For individuals in the trial overall, greater proportions treated with liraglutide 3.0 mg versus placebo were in the higher weight loss categories: A 7.4%, 34.3%; B 29.5%, 38.6%; C 30.1%, 16.6%; D 18.7%, 7.0%; and E 14.4%, 3.5%. For those completing the IWQOL-Lite (n=1890 liraglutide 3.0 mg, n=886 placebo) and SF-36 (n=1689, n=796 respectively), similar profiles were observed, with liraglutide 3.0 mg achieving higher categorical weight loss than placebo. Changes in IWQOL-Lite total score were lowest in the weight gain category (3.45, 3.97) and increased with increasing categorical weight loss: B 7.63, 7.61; C 10.61, 10.92; D 12.61, 16.50; E 17.27, 15.35. Changes in SF-36 physical component summary scores, but not mental component summary scores, followed a similar pattern. CONCLUSIONS: We observed higher proportions of subjects achieving greater categorical weight loss with liraglutide 3.0 mg versus placebo as adjunct to D&E. With greater categorical weight loss, greater improvements in IWQOL-Lite total and SF-36 physical component summary scores were observed.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PSY91

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders

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