Poster Presentation Australian & New Zealand Obesity Society 2016 Annual Scientific Meeting

Improvement in SF-36-derived health utility score with liraglutide 3.0 mg versus placebo over 3 years in prediabetes (#241)

Cilla Haywood 1 , Ronnette L Kolotkin 2 , Gabriel Smolarz 3 , Henrik H Meincke 4 , Jakob B Bjorner 5
  1. Austin Health, Heidelberg, VIC, Australia
  2. Quality of Life Consulting, Durham, NC, USA
  3. Novo Nordisk Inc, Plainsboro, NJ, USA
  4. Novo Nordisk A/S, Soeborg, Denmark
  5. Optum Life Sciences Inc, Lincoln, RI, USA

Objectives: Liraglutide 3.0 mg is a glucagon-like peptide-1 (GLP-1) analogue 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, randomised, double-blind, placebo-controlled, parallel-group, multi-centre, multinational trial (NCT01272219). Participants were ≥18 years with prediabetes (no type 2 diabetes) and either obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with hypertension or dyslipidaemia. 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 analysed.

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.

Conclusion: Liraglutide 3.0 mg is associated with improved health utility compared with placebo for weight management in people with prediabetes over 3 years.