Health-related quality of life in people with type 2 diabetes participating in the LEADER trial

Abstract

Aims: To assess health-related quality of life (HRQoL) in people with type 2 diabetes (T2D) participating in the LEADER cardiovascular outcomes trial using the five-dimension European Quality of Life questionnaire (EQ-5D).

Materials and methods: The EQ-5D was administered every 12 months in a subset of patients from Canada, Denmark, Germany, Ireland, Italy, Netherlands, Spain, Sweden, the United Kingdom and the United States. We compared changes in utility index scores and visual analogue scale (VAS) scores from baseline to 36 months in participants treated with liraglutide and placebo. We also assessed which complications had the greatest impact on quality of life.

Results: At 36 months, less deterioration in EQ-5D utility index score was seen in the liraglutide group (-0.058) than in the placebo group (-0.082; estimated treatment difference [ETD] 0.023, 95% confidence interval [CI] 0.004;0.043; P = 0.020). A smaller decrease in EQ-5D VAS score was also demonstrated in the liraglutide group (-3.51) vs. the placebo group (-5.45; ETD 1.94, 95% CI 0.32;3.57; P = 0.019). The benefits of liraglutide treatment compared with placebo were driven primarily by shifts in the domains of mobility and self-care. The most influential events contributing to poorer HRQoL were stroke, heart failure, malignant neoplasm and confirmed hypoglycaemia.

Conclusions: Liraglutide demonstrated a modest but significant benefit in patient-reported health status using the EQ-5D, compared with placebo. This benefit may be of clinical relevance and requires further study.

Keywords: EQ-5D; LEADER; health-related quality of life; liraglutide; patient-reported outcomes; type 2 diabetes.

Conflict of interest statement

M.A.N. reports fees for serving on advisory boards from Berlin‐Chemie, Boehringer Ingelheim, Eli Lilly, Fractyl, GlaxoSmithKline, Hanmi, Merck Sharp & Dohme, Novo Nordisk, Sanofi‐Aventis and Intarcia Therapeutics/Servier, lecture fees from Berlin‐Chemie, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novo Nordisk, Sanofi‐Aventis, AstraZeneca and Medscape, grant support from AstraZeneca, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novo Nordisk, Novartis and travel support in conjunction with all listed activities. J.F.E.M. reports fees for serving on committees from AstraZeneca, Braun, ACI Clinical, Fresenius, Celgene, AbbVie, Novo Nordisk, Roche, Sandoz, Lanthio Pharma, Sanifit, Relypsa and ZS Pharma, lecture fees from AstraZeneca, Amgen, Braun, Fresenius, Celgene, Gambro, AbbVie, Medice, Novo Nordisk, Roche, Sandoz, Relypsa and ZS Pharma, and grant support from Celgene, AbbVie, Novo Nordisk, Roche, Sandoz. J.B.B. reports consulting fees paid to his employer and travel support for activities from Adocia, AstraZeneca, Dance Biopharm, Dexcom, Elcelyx Therapeutics, Eli Lilly, Fractyl, GI Dynamics, Intarcia Therapeutics, Lexicon, Metavention, NovaTarg, Novo Nordisk, Orexigen, PhaseBio, Sanofi, Senseonics, Shenzhen HighTide, Takeda and vTv Therapeutics, grant support from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GI Dynamics, GlaxoSmithKline, Intarcia Therapeutics, Johnson & Johnson, Lexicon, Medtronic, Merck, Novo Nordisk, Orexigen, Sanofi, Scion NeuroStim, Takeda, Theracos and vTv Therapeutics. He holds stock options in Mellitus Health and PhaseBio, has served on the board of the AstraZeneca HealthCare Foundation, and is supported by a grant from the National Institutes of Health (UL1TR001111). A.G. reports fees for serving on advisory boards from Novo Nordisk and GlaxoSmithKline. Q.Y., H.B.‐T. and H.F.‐L. are employees of Novo Nordisk. S.P. reports honoraria from Novo Nordisk related to consultancy and LEADER Trial Steering Committee activities.

© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1

A, Change in mean five‐dimension European Quality of Life questionnaire (EQ‐5D) index score. B, Change in mean EQ‐5D visual analogue scale (VAS) score. Estimated data. Patients with an observed value contributed to the analysis. Patients who died were given a value of zero at the first planned visit after death. Change from baseline to 36‐month assessment was analysed using a linear mixed model, accounting for repeated measures within patients. Interaction between visit and treatment, sex, region and antidiabetic therapy, respectively, at baseline are included as factors, and interaction between visit and baseline EQ‐5D index/VAS score and age at baseline, respectively, are included as covariates. EOT, end of trial

Figure 2

A, Change in five‐dimension European Quality of Life questionnaire (EQ‐5D) utility index score for key factors and events. B, Change in EQ‐5D visual analogue scale (VAS) score for key factors and events. Change from baseline analysed using a linear mixed model accounting for repeated measures within patients using a compound symmetry residual covariance matrix. Factors: treatment, sex, region, cardiovascular (CV) risk at baseline, stroke, cancer, severe hypoglycaemia, confirmed hypoglycaemia, myocardial infarction (MI), heart failure, foot ulcer, retinopathy, nephropathy, weight change of 5%, glycated haemoglobin (HbA1c)