PS-P15-7: EFFECT OF ESAXERENONE ON UNCONTROLLED NOCTURNAL HYPERTENSION FIRST EVALUATED BY 2 UPPER-ARM/WRIST HOME MONITORING DEVICES (EARLY-NH STUDY)

Abstract

Objective: Nocturnal hypertension is one of the phenotypes of masked hypertension, which affects 30–50% of hypertensive patients, and it cannot be adequately controlled with a single agent. The mineralocorticoid receptor (MR) is activated in an aldosterone-independent manner in diabetes, obesity, salt sensitivity, and excessive salt intake. As all of these conditions are associated with nocturnal hypertension, MR blockers which exert not only antihypertensive but also organ-protective effects are considered the optimal antihypertensive option. Recently, we have developed 2 types (upper-arm and wrist) of nocturnal home blood pressure (BP) monitoring (HBPM) devices. Using these devices, we evaluated the effects of esaxerenone on nighttime home BP and organ damage (UACR and NT-proBNP) in uncontrolled nocturnal hypertensive patients on medication using one drug, either angiotensin receptor blocker (ARB) or calcium channel blocker (CCB). Design and method: EARLY-NH study (jRCTs031200364) was a multicenter, open-label, interventional study in nocturnal hypertensive patients. Nighttime BP was automatically measured at 2, 3, and 4AM with upper-arm (OMRON HEM-9700T), and wrist (OMRON HEM-9601T) HBPM devices. The BP data were electronically collected. Inclusion criteria were: 1) aged ≧ 20 years, 2) receiving one ARB or CCB, 3) nighttime home systolic BP (SBP) ≧ 120 mmHg. Over the 12-week study period, esaxerenone was started at the initial dose of 1.25 or 2.5 mg/day, and could be titrated up to 5 mg/day at weeks 4 and 8, based on the individual patient's condition. The primary efficacy endpoint was the change from baseline in nighttime home BP [SBP and diastolic BP (DBP)] measured by the upper-arm device at week 12. Secondary endpoints included changes in nighttime home BP measured by the wrist device, and levels and control rate of office and home BPs, %change in UACR and NT-proBNP, and safety variables including adverse events, eGFR, and serum potassium. Results: The 93 patients with uncontrolled nocturnal hypertension were successfully enrolled [age: 67.6 years; man: 50.5%; ARB/CCB: 48.4/51.6%; nighttime home SBP/DBP (upper-arm: 132.4/78.4 mmHg; wrist: 130.4/73.1 mmHg); morning home SBP/DBP: 143.8/86.7 mmHg; office SBP/DBP: 147.2/84.1 mmHg; UACR: 110.4 mg/gCr; NT-proBNP: 83.7 pg/mL; serum potassium: 4.0 mEq/L; eGFR: 69.7 mL/min/1.73m2]. Results for the efficacy, safety, and exploratory analysis will be presented. Conclusions: EARLY-NH study will provide the first clinical evidence of the efficacy and safety of esaxerenone on uncontrolled nocturnal hypertension evaluated by 2 newly developed different upper-arm and wrist HBPM and on organ damage. These results will contribute to digital management of hypertension using home BP.