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<p>Mineralocorticoid receptor blockers (MRBs) are positioned as second-line antihypertensive agents in the 2025 Japanese Society of Hypertension guidelines, yet evidence in older patients remains limited. This 12-week, multicenter, randomized, open-label, parallel-group, non-inferiority ESCORT-HT study (jRCTs031240300; September 2024–June 2025) compared esaxerenone with angiotensin II receptor blockers (ARBs) as add-on therapy to amlodipine in Japanese patients aged ≥65 years whose morning home systolic blood pressure (SBP) remained ≥135 mmHg despite stable amlodipine. The mean age was 75.5 years in both the esaxerenone (<i>n</i> = 202; female: 52.5%) and ARB (<i>n</i> = 200; female: 56.5%) groups. At the end of treatment, the least squares mean change from baseline in morning home SBP (primary endpoint) was −10.6 (95% confidence interval: −12.0, −9.1) mmHg with esaxerenone treatment and −9.0 (−10.4, −7.5) mmHg with ARB treatment; the between-group difference was −1.6 (−3.7, 0.5) mmHg, meeting the pre-defined non-inferiority margin (3.8 mmHg). Both treatments lowered the&#xa0;urine albumin-to-creatinine ratio, whereas only esaxerenone significantly reduced N-terminal pro-B-type natriuretic peptide. Treatment-emergent adverse events occurred in 25.1% and 30.8% of the esaxerenone and ARB groups; serious events were reported in 2 versus 7 patients, including one death (esaxerenone group). Hyperkalemia occurred in one esaxerenone-treated patient and none who received ARBs. No serious adverse event was judged to be drug-related. Esaxerenone was non-inferior to ARBs in lowering morning home SBP and showed a favorable safety profile in older Japanese patients with inadequately controlled hypertension on amlodipine. These data support the clinical use of esaxerenone as an effective second-line treatment option for this population.</p><p></p>

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Esaxerenone versus angiotensin II receptor blockers as second-line therapy in older Japanese patients with uncontrolled hypertension on calcium channel blockers: the randomized, open-label ESCORT-HT study

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  • 发表日期：

    2026年4月24日

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  • Kazuomi Kario,
  • Hiroyuki Ohbayashi,
  • Hajime Ishii,
  • Mitsutoshi Kato,
  • Minoru Nozaki,
  • Norio Abiru,
  • Toshiki Fukui,
  • Kazushi Nomura,
  • Yasushi Fukushima,
  • Naoki Itabashi,
  • Kazuaki Uchiyama,
  • Masafumi Nishizawa,
  • Yoshiki Hata,
  • Noriko Nakamura,
  • Satoshi Kodono,
  • Kunio Hirano,
  • Tomohiro Katsuya,
  • Tatsuo Shimosawa,
  • Kazuhito Shiosakai,
  • Go Kato,
  • Takashi Taguchi,
  • Mitsuru Ohishi

摘要

Mineralocorticoid receptor blockers (MRBs) are positioned as second-line antihypertensive agents in the 2025 Japanese Society of Hypertension guidelines, yet evidence in older patients remains limited. This 12-week, multicenter, randomized, open-label, parallel-group, non-inferiority ESCORT-HT study (jRCTs031240300; September 2024–June 2025) compared esaxerenone with angiotensin II receptor blockers (ARBs) as add-on therapy to amlodipine in Japanese patients aged ≥65 years whose morning home systolic blood pressure (SBP) remained ≥135 mmHg despite stable amlodipine. The mean age was 75.5 years in both the esaxerenone (n = 202; female: 52.5%) and ARB (n = 200; female: 56.5%) groups. At the end of treatment, the least squares mean change from baseline in morning home SBP (primary endpoint) was −10.6 (95% confidence interval: −12.0, −9.1) mmHg with esaxerenone treatment and −9.0 (−10.4, −7.5) mmHg with ARB treatment; the between-group difference was −1.6 (−3.7, 0.5) mmHg, meeting the pre-defined non-inferiority margin (3.8 mmHg). Both treatments lowered the urine albumin-to-creatinine ratio, whereas only esaxerenone significantly reduced N-terminal pro-B-type natriuretic peptide. Treatment-emergent adverse events occurred in 25.1% and 30.8% of the esaxerenone and ARB groups; serious events were reported in 2 versus 7 patients, including one death (esaxerenone group). Hyperkalemia occurred in one esaxerenone-treated patient and none who received ARBs. No serious adverse event was judged to be drug-related. Esaxerenone was non-inferior to ARBs in lowering morning home SBP and showed a favorable safety profile in older Japanese patients with inadequately controlled hypertension on amlodipine. These data support the clinical use of esaxerenone as an effective second-line treatment option for this population.