作者: S. Grandy , A. M. Langkilde , J. E. Sugg , S. Parikh , C. D. Sjöström
DOI: 10.1111/IJCP.12341
关键词: Medicine 、 Internal medicine 、 Dapagliflozin 、 Metformin 、 Quality of life 、 Surgery 、 Diabetes mellitus 、 Placebo 、 Randomized controlled trial 、 Visual analogue scale 、 Type 2 Diabetes Mellitus
摘要: SummaryAims This study evaluated health status and health-related quality of life (HRQOL) among patients with type 2 diabetes mellitus (T2DM) treated dapagliflozin, a highly selective sodium-glucose co-transporter (SGLT2) inhibitor that lowers blood glucose by increasing excretion, in double-blind, randomised clinical trial. Methods Subjects T2DM who had inadequate glycaemic control on metformin alone were enrolled 24-week, randomised, placebo-controlled 78-week extension period to evaluate the effect dapagliflozin combination metformin. Subjects 10 mg + metformin (n = 89) compared subjects placebo + metformin (n = 91) at baseline weeks 24, 50 102. EQ-5D change from was derived repeated-measures mixed model, adjusting for EQ-5D, treatment group, time point use rescue medication. Results Mean (SD) index 0.85 (0.16) 0.82 (0.15) (0.19) 0.84 week 102 placebo, respectively. The model indicated no over 102 weeks scores either group. Mean visual analogue scale (VAS) 72.5 (19.5) 73.7 (15.6) 79.8 (13.3) 78.2 (12.1) similar small improvements VAS both groups 102 weeks. Conclusion Patients maintained high HRQOL through groups. Dapagliflozin, novel SGLT2 inhibitor, did not adversely affect 2 years treatment.