Effect of N-terminal pro B-type natriuretic peptide levels on the efficacy and safety of esaxerenone vs trichlormethiazide for the treatment of Japanese patients with uncontrolled essential hypertension: a subanalysis of the EXCITE-HT study

It is currently unknown whether baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, a marker of pressure-related cardiac stress, affect the efficacy and safety of esaxerenone vs trichlormethiazide. This exploratory subanalysis of the EXCITE-HT study aimed to compare the antihypertensive efficacy and safety of esaxerenone vs trichlormethiazide in Japanese patients with uncontrolled essential hypertension stratified by baseline NT-proBNP. EXCITE-HT was a randomized, open-label, parallel-group study. In this subanalysis, patients were divided into low and high NT-proBNP subgroups based on their baseline levels (<125 pg/mL and ≥125 pg/mL, respectively). The low NT-proBNP subgroup included 188 and 212 patients and the high NT-proBNP subgroup included 49 and 41 patients in the esaxerenone and trichlormethiazide groups, respectively. A significant decrease in morning home systolic/diastolic blood pressure (SBP/DBP; the primary endpoint) was observed from baseline to the end of treatment in both NT-proBNP subgroups. In the low NT-proBNP subgroup, esaxerenone was superior to trichlormethiazide in lowering SBP and non-inferior in lowering DBP. Non-inferiority could not be confirmed in the high NT-proBNP subgroup. The geometric mean urinary albumin-to-creatinine ratio significantly decreased from baseline to Week 12 in all subgroups (all P < 0.001 vs baseline). No cases of serum potassium level ≥6.0 mEq/L were reported. These findings suggest that esaxerenone is efficacious across a wide range of baseline NT-proBNP levels, while also supporting its favorable safety profile.