Efficacy of Esaxerenone Plus a Renin-Angiotensin System Inhibitor or Calcium Channel Blocker for Nocturnal Hypertension: A Post Hoc Analysis.

Abstract

Background: Nocturnal blood pressure (BP) is superior to daytime BP in predicting cardiovascular mortality. It is of clinical relevance to evaluate the effect of esaxerenone combination therapy on nighttime BP in patients with uncontrolled hypertension.

Methods: A post hoc analysis of a multicenter, open-label, phase 3 study evaluated the nighttime BP-lowering effects of esaxerenone as monotherapy or in combination with a calcium channel blocker (CCB) or renin-angiotensin system inhibitor (RASi) in Japanese patients with uncontrolled hypertension. In addition, the effect on N-terminal pro B-type natriuretic peptide (NT-proBNP), a known biomarker of cardiovascular disease prognosis, was evaluated.

Results: In total, 270 patients were included in this analysis (172, 49, and 49 patients in the monotherapy, CCB, and RASi groups, respectively). The 24-hour ambulatory systolic BP reduction from baseline was -10.0, -6.0, and -17.0 mmHg in the monotherapy, CCB, and RASi groups, respectively. Nighttime systolic BP decreased significantly from baseline to Week 28 in all groups (P <0.001 each); the RASi group showed the greatest change (-20.6 mmHg). NT-proBNP decreased significantly in all three treatment groups.

Conclusions: Esaxerenone when used in combination with a CCB or RASi, but especially when used in combination with a RASi, may be a useful treatment option for patients with uncontrolled hypertension to control nocturnal BP.