CHANGE IN QUALITY OF LIFE (EQ-5D) AMONG TYPE 2 DIABETES MELLITUS PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN PLUS SULFONYLUREA AND TREATED WITH DAPAGLIFLOZIN AS TRIPLE THERAPY REGIMEN FOR 24 WEEKS
Author(s)
Sternhufvud C1, Rohwedder K2, Sugg J3, Grandy S3
1AstraZeneca, Mölndal, Sweden, 2AstraZeneca R&D, Mölndal, Sweden, 3AstraZeneca LP, Wilmington, DE, USA
OBJECTIVES: Dapagliflozin, a novel, selective, oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, lowers glycated hemoglobin (HbA1c) along with reduction in body weight. This study evaluated health-related quality of life (HRQOL) among type 2 diabetes mellitus (T2DM) patients treated with dapagliflozin in triple therapy during a 24-week period. METHODS: Patients with T2DM (mean age 61 years, 49% men, 96% with body mass index ≥25 kg/m) who had inadequate glycemic control on combination of metformin (MET) and sulfonylurea (SU) were enrolled in a 24-week, international, double-blind, randomized, placebo-controlled study (NCT01392677) to evaluate the effect of dapagliflozin in combination with MET plus SU on HbA1c and body weight. Patients completed the EuroQol Group EQ-5D survey at baseline and at week 24 for evaluation as a secondary objective. Patients treated with dapagliflozin 10 mg + MET + SU (n = 108) were compared with patients treated with placebo + MET + SU (n = 108), based on ANCOVA model with treatment group as an effect and baseline value as a covariate. RESULTS: EQ-5D visual analog scale (VAS, 0-100) baseline means (SD) were 74.6 (20.0) and 73.1 (20.5) for the dapagliflozin and placebo groups, respectively. Corresponding 24-week values were 78.4 (15.2) and 76.8 (16.9), respectively. VAS scores improved in both groups from baseline to week 24; however, there was no significant difference between groups (0.9; CI: -2.9, 4.8; p-value: 0.63) in adjusted change from baseline. EQ-5D index (scores 0-1) baseline means were 0.84 (0.16) and 0.85 (0.16) for dapagliflozin and placebo, respectively. Corresponding 24-week values were 0.83 (0.17) and 0.83 (0.16), respectively. There was no difference in adjusted change from baseline between treatment groups (0.01; CI: -0.03, 0.05; p-value: 0.68). CONCLUSIONS: Similar to other dapagliflozin studies, patients in the present study maintained high HRQOL scores with dapagliflozin over a 24-week period.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PDB110
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders