P1026THE EFFECT OF DAPAGLIFLOZIN ON 24-HOUR BLOOD PRESSURE IN PATIENTS WITH TYPE-2 DIABETES MELLITUS: A DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL

Abstract

Abstract Background and Aims Arterial hypertension is present in >90% of patients with type-2 diabetes mellitus (DM). Previous evidence suggests that sodium-glucose transporter 2 (SGLT-2) inhibitors can effectively manage hyperglycemia, but also reduce office blood pressure (BP) levels. The aim of this study is to evaluate the effects of dapagliflozin on ambulatory brachial BP 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 brachial SBP decreased in the active (128.97±12.57 vs 123.17±12.35; p<0.001) but was similar in the control group (128.95±12.41 vs 128.86±13.45; p=0.942). Corresponding changes in 24-hour SBP levels was greater in the dapagliflozin group compared with the placebo group (-5.80±9.48 vs -0.10±8.70 mmHg; p=0.005). Similarly, 24-hour DBP decreased in the active (77.33±7.30 vs 75.11±6.37; p=0.008) and was unchanged in the placebo group (78.86±8.66 vs 78.96±7.64; p=0.911). Decrease in brachial pulse pressure (PP) was greater in the active group (-3.57±6.67 vs -0.21±6.31 mmHg; p=0.019), while 24-hour heart rate was stable in both groups. Dapagliflozin and placebo treatments were associated with similar rates of generally mild adverse effects. Conclusion Treatment with dapagliflozin can produce statistically significant and clinically meaningful reductions in 24-hour BP levels in type-2 diabetics. These agents can improve BP control in this population.