Lack of Health-Related Quality of Life and Patient-Centred Outcome Measures in Randomized Controlled Trials Conducted for Diabetes Pharmacotherapy: SGLT-2 Receptor Inhibitors as An Example.

BACKGROUND Use of SGLT-2 receptor inhibitors has been associated with weight loss and a low rate of hypoglycemia in comparison to sulfonylureas. These factors may improve health-related quality of life for patients with diabetes. OBJECTIVES To systematically explore randomized controlled trials (RCTs) involving SGLT-2 receptor inhibitors that reported health-related quality of life changes. METHODS A systematic review of SGLT-2 receptor inhibitors clinical trials, limited to RCTs and English language, was conducted utilizing PubMed databases. RESULTS One-hundred and eighteen RCTs were reviewed and 62 RCTs meeting the inclusion criteria were assessed. All 62 RCTs reported body mass index (BMI) changes and HgbA1c reduction. Measures of health-related quality-of-life (HRQoL) were reported in only 2 RCTs. Both studies illustrate improvement in HRQoL domains for SGLT-2 receptor inhibitors in comparison to the other arms in the RCTs. CONCLUSIONS Only a small portion of RCTs involving SGLT-2 receptor inhibitors reported on HRQoL. Because of the potential for weight loss and hypoglycemia avoidance to improve HRQoL, future studies of SGLT-2 receptor inhibitors should measure and report on patient-centred outcomes such as HRQoL.