The use of mineralocorticoid receptor antagonists (MRA) as anti-hypertensive therapy has been limited due to concern of potential hyperkalemia among patients with T2D. The aim of this study was to investigate the effect on blood pressure (BP) and feasibility of use of selective MRA eplerenone in T2D. We randomized 140 patients with T2D and established or high risk of cardiovascular disease to either eplerenone or placebo for 26 weeks. Target study medication dose was 200 mg/day or 100mg/day for patients with an eGFR >60 or 40-60 ml/min/1,73m2, respectively. Outcomes of this substudy was change in 24h-ABPM, office-BP from baseline and incident hyperkalemia (s-K ≥ 5.5 mmol/L). A decrease was found in office systolic BP, in the eplerenone group as compared with placebo (-6 mmHg, [-11; -1], P=0.03). Mean 24h-systolic- (SBP) and diastolic BP (DBP) decreased significantly with eplerenone (SBP: -5 mmHg [-8; -2], P <0.001; DBP: -3 mmHg [-4; -1] P <0.001). The difference in 24h ABPM-change between groups at end-of-study being borderline significant (-3 mmHg [-7; 1], P=0.1). Number of patients with incident hyperkalemia did not differ (eplerenone vs. placebo 6 vs. 2, P = 0.27); with no incidences of severe hyperkaliemia (s-K ≥6.0 mmol/L). We conclude eplerenone to be a feasible option in the treatment of T2D patients with hypertension and normal mean eGFR.
Figure: 24-h ABPM change; comparison of baseline and end-of-study.
N. Høeg Brandt-Jacobs: None. J.B. Rasmussen: None. M. Johansen: None. P. Rossignol: None. J. Faber: None. M. Schou: None. C.M. Kistorp: None.