Abstract 10606: Blood Pressure Reduction With Dapagliflozin in Patients With Type 2 Diabetes and Cardiovascular Disease
Background: Dapagliflozin (DAPA) is a selective SGLT2 inhibitor shown to reduce hyperglycemia and weight in patients with type 2 diabetes mellitus (T2DM). DAPA has demonstrated efficacy as monotherapy or combined with oral antidiabetic drugs and/or insulin. The clinical effect of DAPA, which has mild osmotic diuretic properties, on systolic blood pressure (SBP) was analyzed in 2 trials (Study [ST] 1: NCT01031680, N=922; ST2: NCT01042977, N=964) of DAPA vs placebo (PBO) added to usual care in T2DM patients with established cardiovascular disease (CVD). Glycemic efficacy and overall safety in these studies have been reported.
Methods: Patients received DAPA 10 mg (ST1: n=460; ST2: n=482) or PBO (ST1: n=462; ST2: n=483) added to stable antidiabetic and antihypertensive (AHT) background medication. We conducted prespecified and post-hoc analyses of SBP-related measures comparing treatment groups overall and in predefined age strata (<65 and ≥65 y). Data following changes in AHT medications were excluded.
Results: DAPA-treated patients showed a rapid and sustained moderate, PBO-subtracted SBP reduction starting with the first measurement (wk 1) after treatment initiation (figure). In both studies, DAPA-mediated SBP reductions were significant at 8 and 24 wks overall and in patients <65 y. In patients with baseline (BL) SBP ≥130 mm Hg, a larger proportion in the DAPA vs PBO group achieved an SBP <130 mm Hg (ADA goal) (ST1: 24.3% vs 13.1%; ST2: 20.4% vs 14.0%) at 52 wks. In patients with BL SBP ≥130 mm Hg, a larger proportion of DAPA-treated patients showed a drop of ≥3 or ≥5 mm Hg vs PBO (analyzed in ST2 only). PBO-subtracted changes in diastolic BP were -1.50 mm Hg in ST1 and -1.73 mm Hg in ST2. In DAPA-treated patients, there was no meaningful change in seated heart rate.
Conclusions: In addition to reducing HbA1c and weight, DAPA provides rapid and sustained clinically meaningful SBP reductions resulting in more patients with T2DM and established CVD achieving recommended SBP goals.
- © 2013 by American Heart Association, Inc.