Abstract 13144: Effects of Dapagliflozin on Blood Pressure in Diabetic Patients With Hypertension Inadequately Controlled by a Renin-Angiotensin System Blocker
Hypertension is common in patients with type 2 diabetes (T2D) and is usually treated with an ACEi or ARB. Dapagliflozin (DAPA), an insulin-independent sodium glucose cotransporter 2 inhibitor that blocks reabsorption of glomerular-filtered glucose, has demonstrated glycemic benefits. Its osmotic diuretic effect has led to clinically meaningful reductions in BP in glycemic efficacy trials. This multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial evaluated efficacy and safety of DAPA 10 mg in reducing seated systolic BP and HbA1c in 613 patients with T2D and inadequately controlled glycemic levels and hypertension, despite treatment with oral antidiabetic agent(s) + ACEi or ARB. Patients with suboptimally controlled HbA1c (≥7.0% and ≤10.5%) and elevated BP (seated systolic ≥140 and <165 mm Hg + seated diastolic ≥85 and <105 mm Hg) were randomized to placebo (n=311) or DAPA 10 mg (n=302) for 12 weeks in addition to their previous regimen. Baseline demographics and disease characteristics were similar across treatment groups; mean age was 55.9 years. Significantly greater reductions in seated and 24-hour ambulatory systolic BP and HbA1c were reported with DAPA vs placebo (table). A higher proportion of DAPA patients achieved seated BP <140/90 at Week 12 vs placebo. Adjusted mean weight loss at Week 12 was 1.01 kg for DAPA and 0.25 kg for placebo. Marked potassium abnormalities were more frequent with placebo (2.6%) vs DAPA (1.0%); marked sodium abnormalities were similar at ≤1%; <3% of patients in either group experienced asymptomatic orthostatic hypotension. No clinically relevant changes in GFR at 12 weeks were observed. DAPA 10 mg added to another oral antidiabetic agent + ACEi/ARB is effective in reducing systolic BP and HbA1c in patients with T2D and inadequately controlled glycemic and BP levels, potentially obviating the need for additional antihypertensive medication.
- © 2013 by American Heart Association, Inc.