Key result
Esaxerenone reduces morning home SBP by ~3 mmHg more than trichlormethiazide in hypertensives with T2D.
Why the study?
The study explored the antihypertensive efficacy and safety of esaxerenone versus trichlormethiazide in patients with type 2 diabetes mellitus stratified by baseline antihypertensive agent and urinary albumin-to-creatinine ratio.
Does esaxerenone reduce morning home SBP/DBP compared to trichlormethiazide in Japanese patients with type 2 diabetes mellitus and uncontrolled essential hypertension?
RCT (n=234)
Open-label
Randomized
Yes
Does esaxerenone reduce morning home SBP/DBP compared to trichlormethiazide in Japanese patients with type 2 diabetes mellitus and uncontrolled essential hypertension?
Effect estimate: Mean Difference -2.5 (95% CI -4.8, -0.2)
Absolute Event Rate: -12.1% vs -9.6%
Esaxerenone offers a thiazide alternative for morning SBP control in T2DM hypertension; extends RCT evidence for MRAs in this population.
This subgroup analysis of the randomized, open-label, parallel-group EXCITE-HT study explored the antihypertensive efficacy and safety of esaxerenone vs trichlormethiazide in patients with type 2 diabetes mellitus (T2DM), stratified by baseline antihypertensive agent (angiotensin receptor blocker [ARB] or calcium channel blocker [CCB]) and urinary albumin-to-creatinine ratio (UACR; <30 or ≥30 mg/gCr). Using thresholds consistent with those used in the main study to interpret the difference in systolic/diastolic blood pressure (SBP/DBP), the between-group difference in least squares mean change (95% confidence interval [CI]) in morning home SBP/DBP at the end of treatment was -2.5 (-4.8, -0.2)/ - 0.7 (-2.0, 0.6) mmHg. Trends were consistent across all subgroups. The geometric mean UACR significantly decreased from baseline to Week 12 in the overall population, ARB subgroup (except for esaxerenone-treated patients), CCB subgroup, and both UACR subgroups. The overall incidence of serum potassium ≥5.5 mEq/L was 2.5% with esaxerenone and 0.9% with trichlormethiazide, with no cases of serum potassium ≥6.0 mEq/L. In this patient population, esaxerenone had a favorable safety profile, achieved blood pressure lowering similar to trichlormethiazide, and elicited a reduction of kidney damage (based on UACR), regardless of baseline antihypertensive agent or UACR.
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Ohishi et al. (2025) conducted an RCT in Uncontrolled essential hypertension with type 2 diabetes mellitus (n=234). Esaxerenone vs. Trichlormethiazide was evaluated on Change in morning home systolic blood pressure from baseline to end of treatment (Mean Difference -2.5, 95% CI -4.8, -0.2). Esaxerenone was non-inferior to trichlormethiazide and superior for reducing morning home systolic blood pressure (mean difference -2.5 mmHg) in hypertensive patients with type 2 diabetes.
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