Why the study?
In contrast to its known antihypertensive effect, there was little evidence regarding the cardioprotective effect of esaxerenone.
Does esaxerenone reduce blood pressure and left ventricular mass index in hypertensive patients with left ventricular hypertrophy taking a RASi or CCB?
Does esaxerenone reduce blood pressure and left ventricular mass index in hypertensive patients with left ventricular hypertrophy taking a RASi or CCB?
Esaxerenone significantly reduced blood pressure and left ventricular mass index in patients with uncontrolled hypertension and left ventricular hypertrophy already on RASi or CCB therapy.
Answers are grounded in this paper and cite their sources.
Hypothesis-generating for esaxerenone in hypertensive LVH on RASi/CCB; leaves open cardioprotective benefit pending RCTs.
In contrast to the antihypertensive effect of esaxerenone, there is little evidence of its cardioprotective effect. We investigated the efficacy and safety of esaxerenone in patients with uncontrolled hypertension and left ventricular hypertrophy taking a renin-angiotensin system inhibitor (RASi) or calcium-channel blocker (CCB). This was a multicenter, open-label, exploratory study with a 24-week treatment period. Esaxerenone was orally administered at an initial dose of 2.5 mg/day (maximum dose: 5 mg/day). The primary endpoints were the change in morning home systolic blood pressure (BP)/diastolic BP and change and percentage change in left ventricular mass index (LVMI) from baseline to end of treatment (EOT). Key secondary endpoints included change from baseline in bedtime home and office BP, achievement rate of target BP, and safety. In total, 60 patients were enrolled. Morning home systolic/diastolic BP was significantly decreased from baseline to EOT in the total population (− 11.5/ − 4.7 mmHg, p < 0.001) and in both the RASi and CCB subcohorts (all p < 0.01). Significant reductions in bedtime home and office BP were shown in the total population and both subcohorts. LVMI was also significantly decreased from baseline to EOT in the total population (− 9.9 g/m 2 , − 8.5%, both p < 0.001) and both subcohorts (all p < 0.05). The incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 35.0% and 3.3%, respectively; most were mild or moderate. No new safety concerns were identified. Esaxerenone showed favorable antihypertensive and cardioprotective effects and safety in hypertensive patients with cardiac hypertrophy. Japan Registry of Clinical Trials (jRCTs071190043).
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Yamamoto et al. (2024) studied this question.
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