Abstract 13165: Dapagliflozin for Reduction of Blood Pressure in Diabetic Patients Inadequately Controlled With Combination Antihypertensive Regimen
Hypertension is a frequent comorbidity of type 2 diabetes (T2D); dual antihypertensive agents (ACEi or ARB plus a second agent) may not provide adequate control. Dapagliflozin (DAPA), a sodium glucose cotransporter 2 inhibitor that blocks reabsorption of renally filtered glucose, has an osmotic diuretic effect that has shown reduced BP in DAPA glycemic efficacy trials. This multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial analyzed efficacy and safety of DAPA 10 mg for reduction of seated systolic BP and HbA1c in 449 adult patients with T2D and inadequate glycemic and BP control, despite treatment with oral antidiabetic agent(s) and/or insulin + ACEi/ARB + second antihypertensive agent. Patients with T2D and elevated BP (seated systolic ≥140 and <165 mm Hg + seated diastolic ≥85 and <105 mm Hg) were randomized to placebo (n=224) or DAPA 10 mg (n=225) for 12 weeks in addition to their multidrug regimen. Baseline demographics were similar across groups: mean age was 56 years, mean HbA1c was 8.04%, and mean seated systolic BP was 151 mm Hg. Second antihypertensives included calcium channel-blocker/beta-blocker/central alpha (55.4%) and thiazide/diuretic (44.5%). DAPA-treated patients had significantly greater reductions vs placebo in seated and 24-hour ambulatory systolic BP and HbA1c (table). A higher proportion of DAPA patients achieved seated BP <140/90 at Week 12. Adjusted mean weight loss was 1.44 kg with DAPA and 0.59 kg with placebo. Few marked potassium abnormalities (≥6 meq/L) were reported (1.8% for DAPA vs 0% for placebo). For both groups, marked sodium changes (<130 or >150 meq/L) were ≤1% and asymptomatic orthostatic hypotension occurred in <3.5%. No clinically relevant changes in GFR at 12 weeks were observed. DAPA 10 mg reduced HbA1c and seated systolic BP in patients with T2D and hypertension who were inadequately controlled with antidiabetics + 2 antihypertensives, without compromising renal safety.
- © 2013 by American Heart Association, Inc.