Key result
Esaxerenone reduced office systolic blood pressure by a mean of 14.4 mmHg at 12 weeks, with factors such as female sex, lower body weight, and non-smoking associated with a stronger antihypertensive effect.
Why the study?
Factors associated with the antihypertensive effects of esaxerenone and serum potassium elevation in patients with hypertension required investigation.
Esaxerenone effectively lowers blood pressure across diverse patient backgrounds, but careful monitoring is required for hyperkalemia in patients with higher baseline potassium or reduced renal function.
Supports esaxerenone for BP lowering with potassium monitoring; extends meta-analytic safety data on hyperkalemia predictors.
This study investigated factors associated with the antihypertensive effects of esaxerenone and the incidence of serum potassium elevation in patients with hypertension. Using pooled data from seven phase III studies, the study analyzed factors associated with changes in office systolic (SBP) and diastolic (DBP) blood pressure from baseline to 12 weeks, and factors associated with incidence of serum potassium levels ≥ 5.5 mEq/L in esaxerenone-treated patients. Overall, 1466 and 1472 patients were included in the full analysis and safety analysis sets, respectively. Male sex (4.02/2.40 mmHg), weight ≥ 78.4 kg (4.62/2.09 mmHg), hypertension duration ≥ 10 years (2.66/1.71 mmHg), prior antihypertensive treatment (2.38/1.40 mmHg), plasma aldosterone concentration ≥ 120 pg/mL (1.66/1.17 mmHg), urinary albumin-to-creatinine ratio (UACR) ≥ 300 mg/gCr (8.94/4.85 mmHg) or 30–299 mg/gCr (5.17/4.15 mmHg), and smoking (2.62/1.27 mmHg) were associated with mean changes in SBP and DBP. Fasting blood glucose ≥ 126 mg/dL (− 2.73 mmHg) was associated with the mean change in SBP only, and older age (65–74 years, − 2.12 mmHg; and ≥ 75 years, − 3.06 mmHg) with mean change in DBP only. Factors significantly associated with incidence of serum potassium levels ≥ 5.5 mEq/L were higher baseline serum potassium (≥ 4.5 mEq/L, odds ratio [OR] 6.702); lower estimated glomerular filtration rate (≥ 90 mL/min/1.73 m 2 , OR 0.148; 60–89 mL/min/1.73 m 2 , OR 0.331 vs 30–59 mL/min/1.73 m 2 , respectively); higher UACR (30–299 mg/gCr, OR 7.317); higher DBP (≥ 100 mmHg, OR 3.248); and grade I hypertension (OR 2.168). Esaxerenone is effective in patients with a broad range of backgrounds, though some factors may predict increased benefit. Regarding elevated serum potassium, careful therapeutic management is recommended for patients with higher baseline serum potassium and reduced renal function. Clinical trial registration : UMIN000047026.
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Ito et al. (2023) studied Hypertension (n=1,466). Esaxerenone vs. Baseline was evaluated on Change in office systolic blood pressure from baseline to 12 weeks (MD -14.4 mmHg, 95% CI -15.0 to -13.7). Esaxerenone reduced office systolic blood pressure by a mean of 14.4 mmHg at 12 weeks, with factors such as female sex, lower body weight, and non-smoking associated with a stronger antihypertensive effect.
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