Health-Related Quality of Life, Measured With EQ-5D-5L in the Select Trial

Speaker(s)

Bjorner J1, Lingvay I2, Bidstrup S3, Rasmussen S3, Colhoun HM4, Deanfield J5, Ferreira D6, Hjelmesæth J7, Horn DB8, Koroleva A3, Lincoff AM9, Lübker C3, Schiele F10, Wilding J11, Kushner RF12
1QualityMetric, an IQVIA business, Johnston, RI, USA, 2Department of Internal Medicine/Endocrinology and Peter O’Donnel Jr School of Public Health, UT Southwestern Medical Center, Dallas, TX, USA, 3Novo Nordisk A/S, Søborg, Denmark, 4Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK, 5Institute of Cardiovascular Sciences, University College London, London, UK, 6Intensive Care Department, Hospital da Luz Lisboa, Lisbon, Portugal, 7Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway and Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway, 8Department of Surgery, University of Texas McGovern Medical School, Houston, TX, USA, 9Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Cleveland, OH, USA, 10Université de Franche-Comté, Besançon, France, 11Department of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool, UK, 12Northwestern University Feinberg School of Medicine, Chicago, IL, USA

Presentation Documents

OBJECTIVES: In the SELECT trial, semaglutide, a glucagon-like peptide-1 receptor agonist, reduced major adverse cardiovascular events by 20% versus placebo in patients with established cardiovascular disease (CVD) and overweight or obesity but without diabetes. We report prespecified analyses of treatment effects on patient-reported health-related quality of life, measured by EQ-5D-5L, at week 104.

METHODS: The EQ-5D-5L questionnaire was self-completed at baseline, after 20 weeks and yearly thereafter. EQ-5D-5L provides 2 overall scores: health utility and general health. The health utility score (1=perfect health; 0=death) is based on five dimension-specific items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Following NICE recommendations, item responses were combined using UK health preferences for EQ-5D-3L. The general health score is based on a visual analogue scale (VAS: 100=best health;0=worst health).

RESULTS: The study randomised 17,604 patients. At week 104, questionnaire completion rates were 78% for semaglutide versus 77% for placebo. Baseline mean health utility was 0.82 and mean VAS 77.15 for both semaglutide and placebo groups. Utility scores increased with semaglutide (mean change ± standard error [SE], 0.010±0.002) and fell in the placebo group (‑0.008±0.002); estimated treatment difference (ETD) ± SE was 0.018±0.003. All dimension-specific scores showed statistically significant improvement with semaglutide, except for anxiety/depression where change was insignificant. VAS scores improved to a greater extent with semaglutide (2.52±0.16) compared with placebo (0.92±0.16); ETD was 1.60±0.23). ETDs in EQ-5D-5L utility score were consistent irrespective of age, region, race, body mass index, chronic kidney disease and CVD types at baseline but larger among women (0.035±0.005) than men (0.012±0.003).

CONCLUSIONS: In patients with CVD and obesity/overweight, quality of life improved with semaglutide compared to placebo after two years of therapy. This adds to the beneficial outcomes from the SELECT trial. The improvement in health utility is equivalent to 7 additional days spent in full health per year.

Code

PCR221

Topic

Patient-Centered Research

Topic Subcategory

Health State Utilities

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)