PS-P15-9: EFFECT OF MINERALOCORTICOID RECEPTOR BLOCKER, ESAXERENONE, ON HOME BLOOD PRESSURE AND CARDIAC HYPERTROPHY IN HYPERTENSIVE PATIENTS WITH LVH (ESES-LVH STUDY)

Abstract

Objective: Cardiac hypertrophy is a prognostic factor in hypertensive patients, and attenuation of the hypertrophy with sustained antihypertensive treatment is important to delay the progression to heart failure. Although most classes of antihypertensive agents have evidence of cardiac hypertrophy regression, there is insufficient evidence for mineralocorticoid receptor blockers (MRB); only one report states that MRB has a more pronounced regressive effect when used in combination with a renin-angiotensin system (RAS) inhibitor. Esaxerenone is a novel selective nonsteroidal MRB which has been recently approved for the treatment of hypertension, to date however, there is little evidence of the effectiveness and safety of esaxerenone in hypertensive patients with cardiac hypertrophy. The study was aimed to evaluate the effectiveness and safety of esaxerenone in Japanese hypertensive patients with left ventricular hypertrophy (LVH) whose blood pressure (BP) was inadequately controlled with a RAS inhibitor or calcium channel blocker (CCB). Design and method: ESES-LVH study (jRCTs071190043) was a multicenter, open-label, interventional study. Main inclusion criteria were hypertensive patients (20 years) with morning and bedtime home BP: 135–159 mmHg systolic BP (SBP) and/or 85–99 mmHg diastolic BP (DBP) taking a RAS inhibitor or CCB, and patients with LVH (diagnosed with echocardiography, ECG, or left ventricular mass index [LVMI]). Over the 24-week study period, the initial dose of esaxerenone was started at 1.25 or 2.5 mg/day, and increased to 5 mg/day at weeks 4 and 8, based on the individual patient's condition. The primary endpoints were change from baseline in morning home BP, and change and %change in LVMI, at the end of treatment (EOT). Secondary endpoints included changes in bedtime home and office BP, proportion of patients achieving target BP, changes in echocardiographic parameters, and safety variables including adverse events, eGFR, and serum potassium levels. Results: Baseline characteristics of the 58 enrolled patients were mean age, 64.8 years; male, 70.7%; RAS inhibitor/CCB, 32.8/67.2%; mean morning home SBP/DBP, 142.8/85.0 mmHg; mean LVMI 118.1 g/m2; left ventricular ejection fraction 62.8%; serum potassium level 4.1 mEq/L; and mean eGFRcreat 71.3 mL/min/1.73m2. Mean change from baseline at EOT was -11.5/-4.7 mmHg in the morning home BP, and mean change and % change in LVMI were -9.9 g/m2 and-8.5%, respectively (p < 0.001 each). Detailed effectiveness and safety results will be presented. Conclusions: ESES-LVH study will provide the first clinical evidence of not only the antihypertensive and LVH-regressive effects of esaxerenone, but also its safety in Japanese hypertensive patients with cardiac hypertrophy.