SO036THE EFFECT OF DAPAGLIFLOZIN ON AMBULATORY AORTIC BLOOD PRESSURE AND ARTERIAL STIFFNESS PARAMETERS IN PATIENTS WITH TYPE-2 DIABETES MELLITUS: A DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL

Abstract

Abstract Background and Aims Arterial stiffness is a prominent risk factor for heart failure and overall mortality in patients with type-2 diabetes mellitus (DM). Sodium-glucose co-transporter 2 (SGLT-2) inhibitors reduce the incidence of heart failure and death in these patients. The aim of this study is to evaluate the effects of dapagliflozin on ambulatory central blood pressure (BP) levels and arterial stiffness parameters in patients with type-2 DM. Method This is a double-blind, randomized, placebo-controlled clinical trial including 85 adult patients with type-2 DM on monotherapy or combination therapy with two of: metformin, sulphonylurea, DDP-4 inhibitor, or insulin. Patients were randomized in a 1:1 ratio to oral dapagliflozin 10 mg per day or placebo for 12 weeks. Study participants underwent 24-h ambulatory BP monitoring with the Mobil-O-Graph NG monitor at baseline and study-end. Results Baseline demographic, clinical and laboratory parameters were similar in the two groups (age 61.74±6.73 vs 60.64±9.35; p=0.534). During follow-up, 24-hour central SBP/DBP significantly decreased in dapagliflozin (117.41±10.52/78.88±7.25 vs 113.30±8.75/77.25±6.54; p=0.002/p=0.047), but not in the placebo group. Corresponding reductions of 24-hour central SBP (-4.12±8.00 vs -0.65±7.77; p=0.046) were greater with dapagliflozin than placebo. Aortic pulse pressure (PP) decreased only in the dapagliflozin group (38.53±7.44 vs 36.05±6.59 mmHg; p=0.004). 24-hour heart-rate adjusted augmentation-index significantly decreased with dapagliflozin. Importantly, there was a significant difference in the change of 24-hour PWV (-0.16±0.32 vs 0.02±0.27; p=0.007) favoring dapagliflozin. Conclusion Treatment with dapagliflozin significantly reduces ambulatory central BP and PWV levels in type-2 diabetics. Improvement in these parameters may substantially contribute to the cardiovascular benefits of SGLT-2 inhibitors.