Age-stratified efficacy and safety of esaxerenone versus angiotensin II receptor blockers in older patients with hypertension: a predefined subanalysis of the ESCORT-HT study

Abstract The ESCORT-HT study recently demonstrated non-inferiority of esaxerenone to angiotensin II receptor blockers (ARBs) in lowering morning home systolic blood pressure (SBP) in Japanese patients aged ≥65 years with inadequately controlled hypertension on amlodipine. This predefined subgroup analysis of the ESCORT-HT study analyzed age-related differences in the efficacy and safety of esaxerenone relative to ARBs. In the 65–74-year subgroup, 98 patients were treated with esaxerenone and 94 with an ARB; in the ≥75-year subgroup, 104 were treated with esaxerenone and 106 with an ARB. The least squares mean difference in morning home SBP between the two treatment groups at end of treatment was −1.1 (95% confidence interval [CI] −3.8, 1.6) mmHg for the 65–74-year subgroup and −2.2 (95% CI −5.2, 0.9) mmHg for the ≥75-year subgroup. The upper bound of the 95% CI was within the pre-defined non-inferiority margin of <3.8 mmHg. The urine albumin-to-creatinine ratio decreased in all groups at Week 12, regardless of age or treatment, and N-terminal pro-B-type natriuretic peptide levels decreased in esaxerenone-treated patients, regardless of age. The incidence of treatment-emergent adverse events was 34.3% (esaxerenone) and 32.0% (ARB) in patients 65–74 years, and 16.7% and 29.6%, respectively, in patients aged ≥75 years. There were no notable increases in the incidence of hyperkalemia or hypokalemia, relative to ARBs, in any of the age subgroups. This predefined subgroup analysis of the ESCORT-HT study showed antihypertensive effects consistent with the non-inferiority of esaxerenone to ARBs in both age groups, and suggested a potential cardioprotective effect, including for patients aged ≥75 years.