title: Patient-reported outcomes among patients with type 2 diabetes mellitus treated with dapagliflozin in a triple-therapy regimen for 52 weeks.
abstract: Patients with type 2 diabetes (T2DM) and inadequate glycaemic control on combination metformin (MET) and sulphonylurea (SU) were enrolled in a 24-week, double-blind, randomized, placebo-controlled study with a 28-week extension. The five-dimension EuroQol questionnaire (EQ-5D), SHIELD Weight Questionnaire-9 (WQ-9), Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) were used to evaluate health status and health-related quality of life (HRQoL) at baseline and week 52. Patients with dapagliflozin 10 mg + MET + SU (n = 108) were compared with patients treated with placebo + MET + SU (n = 108), using a repeated-measures mixed model. EQ-5D visual analogue scale scores, IWQOL-Lite and DTSQ scores improved in the dapagliflozin and placebo groups from baseline to week 52; however, there was no significant difference between groups (p > 0.20). EQ-5D index scores remained the same from baseline to week 52 for dapagliflozin and placebo (p = 0.54). A numerically greater proportion of the dapagliflozin group reported improvement in all nine SHIELD WQ-9 items compared with placebo, and the difference was statistically significant for physical health (p = 0.017). Over 52 weeks of therapy, patients maintained their health status and HRQoL when dapagliflozin was added to the treatment.
authors.affiliation: AstraZeneca LP, Wilmington, DE, USA.
authors.forename: S
authors.initials: S
authors.lastname: Grandy
authors.affiliation: AstraZeneca R&D, Molndal, Sweden.
authors.forename: C
authors.initials: C
authors.lastname: Sternhufvud
authors.affiliation: AstraZeneca R&D, Molndal, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Ryden
authors.affiliation: AstraZeneca LP, Wilmington, DE, USA.
authors.forename: J
authors.initials: J
authors.lastname: Sugg
authors.affiliation: AstraZeneca, Wedel, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Rohwedder
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000523:psychology; D059026:Diagnostic Self Evaluation; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000523:psychology; D005260:Female; D005960:Glucosides / Q000008:administration & dosage*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D011788:Quality of Life; D013453:Sulfonylurea Compounds / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C529054:dapagliflozin; D008687:Metformin
keywords: antidiabetic drug; clinical trial; dapagliflozin; pharmacoeconomics; type 2 diabetes