Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes (GRADE) Study: A Comparative Effectiveness Randomized Clinical Trial
Objective: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in the GRADE study.
Research Design and Methods: 5047 participants with baseline mean age of 57 years, <10 years T2D duration, glycated hemoglobin level of 6.8–8.5%, taking metformin monotherapy were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline in 4885 participants, and at years 1, 2, and 3 (Y1-Y3), using the Quality of Well-Being Self-Administered Scale (QWB-SA) and the 36-Item Short-Form Health Survey physical and mental component summary scales (PCS, MCS). Linear models analyzed changes in HRQoL over time in intention-to-treat analyses.
Results: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at Y1 only. Greater weight loss during Y1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline body mass index showed the greatest improvement in PCS scores at Y1.
Conclusion: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS compared with the other medications at 1 year, which was no longer significant at Y2 and Y3. Improvement was related to weight loss and baseline BMI.