IMPROVEMENT IN SF-36-DERIVED HEALTH UTILITY SCORE WITH LIRAGLUTIDE 3.0 MG VERSUS PLACEBO OVER 3 YEARS IN PREDIABETES

Author(s)

Kolotkin RL1, Smolarz G2, Meincke HH3, Bjorner JB4
1Quality of Life Consulting, Durham, NJ, USA, 2Novo Nordisk Inc, Plainsboro, NJ, USA, 3Novo Nordisk A/S, Søborg, Denmark, 4Optum, Lincoln, RI, USA

OBJECTIVES: Liraglutide 3.0 mg is a glucagon-like peptide-1 (GLP-1) analog currently licensed for weight management in people with obesity (PWO), or overweight with a weight-related comorbidity. This analysis aimed to investigate the effects of liraglutide 3.0 mg (n=1505) versus placebo (n=749), added to a reduced calorie diet and increased physical activity, on health utility in PWO or overweight with comorbidity, over 3 years. METHODS: The study was a 3-year, randomized, double-blind, placebo-controlled, parallel-group, multi-center, multinational trial (NCT01272219). Participants were ≥18 years with prediabetes (no type 2 diabetes) and either obesity (BMI ≥30 kg/m) or overweight (BMI ≥27 kg/m) with hypertension or dyslipidemia. Health-related quality of life was assessed via the Short-Form 36v2 (SF-36) health survey, completed at baseline and 3 years. Health utility (Short-Form 6D; SF-6D) was scored directly from the SF-36 using a validated algorithm.  As sensitivity analyses, SF-36 scores were mapped to the EuroQoL-5D (EQ-5D) index and the SF-36 Physical (PCS) and Mental (MCS) Component Summary scores were analyzed. RESULTS: At Week 160, individuals on liraglutide 3.0 mg had greater weight loss from baseline (‑7.1±8.4%) compared with placebo (-2.7±7.2%); estimated treatment difference (ETD) -4.3% [95%CI -4.9;-3.7], p<0.0001. SF-6D score at baseline [mean (SD)] was 0.76 (0.11) and 0.75 (0.11), and at Week 160 change from baseline was 0.02 (0.12) and 0.01 (0.12) for liraglutide 3.0 mg and placebo, respectively. At Week 160 ETD was 0.014 [95%CI 0.002;0.025], p=0.0182. The EQ-5D score supported these findings, with a higher score for liraglutide 3.0 mg versus placebo; ED 0.007 [95%CI: 0.002;0.013], p=0.0116. Change in SF-36 PCS score was significantly higher (better) at Week 160 compared with placebo: ETD 0.87 [95%CI 0.17;1.58], p=0.0156. CONCLUSIONS: Liraglutide 3.0 mg is associated with improved health utility compared with placebo for weight management in people with prediabetes over 3 years.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PSY56

Topic

Patient-Centered Research

Topic Subcategory

Health State Utilities

Disease

Diabetes/Endocrine/Metabolic Disorders

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