Abstract 10677: Dapagliflozin in Patients With Type 2 Diabetes and Established Cardiovascular Disease: Hypotension and Volume-related Safety

Background: Dapagliflozin (DAPA), a selective SGLT2 inhibitor that causes increased urinary glucose excretion and mild osmotic diuresis, is a compound for treatment of type 2 diabetes mellitus (T2DM). DAPA 10 mg/d vs placebo (PBO) add-on therapy to usual care was assessed in 2 studies in inadequately controlled T2DM patients (HbA1c 7.0%-10.0%) with established cardiovascular disease (Study [ST] 1: NCT01031680, N=922; ST2: NCT01042977, N=964). Published results showed greater reductions in HbA1c, weight, and systolic blood pressure with DAPA vs PBO and that DAPA was well tolerated over 52 wks. We present volume-related safety results from these studies. Methods: Patients in both randomized studies received PBO or DAPA 10 mg added to a stable antidiabetic and antihypertensive background regimen. Patients were stratified by age <65 or ≥65 y, insulin use, and time from the most recent qualifying CV event. A prespecified history of hypertension was an inclusion criterion for ST1 and was present in 93% of patie...