Nighttime home blood pressure lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension: the EARLY-NH study

Kazuomi Kario, Masafumi Nishizawa, Mitsutoshi Kato, Hajime Ishii, Kazuaki Uchiyama, Michiaki Nagai, Nobuo Takahashi, Taro Asakura, Toshihiko Shiraiwa, Tetsuro Yoshida, Mizuki Kaneshiro, Takashi Taguchi, Kazuhito Shiosakai, Kotaro Sugimoto

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

There is limited evidence on the blood pressure (BP)-lowering effect of esaxerenone on home BP, including nighttime BP. Using two newly developed nocturnal home BP monitoring devices (brachial and wrist), this multicenter, open-label, prospective study investigated the nighttime home BP-lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension being treated with an angiotensin receptor blocker (ARB) or calcium-channel blocker (CCB). In total, 101 patients were enrolled. During the 12-week study period, change in nighttime home systolic/diastolic BP from baseline to end of treatment measured by the brachial device was −12.9/−5.4 mmHg in the total population and −16.2/−6.6 and −10.0/−4.4 mmHg in the ARB and CCB subcohorts, respectively (all p < 0.001). For the wrist device, the change was −11.7/−5.4 mmHg in the total population and −14.6/−6.2 and −8.3/−4.5 mmHg in each subcohort, respectively (all p < 0.001). Similar significant reductions were shown for morning and bedtime home BP and office BP. Urinary albumin-to-creatinine ratio, N-terminal pro-brain natriuretic peptide, and cardio-ankle vascular index improved in the total population and each subcohort. Incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 38.6% and 16.8%, respectively; most were mild or moderate. The most frequent drug-related TEAEs were associated with serum potassium elevation (hyperkalemia, 9.9%; blood potassium increased, 3.0%); however, no new safety concerns were raised. Esaxerenone was effective in lowering nighttime home BP as well as morning and bedtime home BP and office BP, safe, and showed organ-protective effects in patients with uncontrolled nocturnal hypertension. Caution is warranted regarding elevated serum potassium levels. [Figure not available: see fulltext.].

Original languageEnglish
Pages (from-to)1782-1794
Number of pages13
JournalHypertension Research
Volume46
Issue number7
DOIs
StatePublished - Jul 2023
Externally publishedYes

Keywords

  • Esaxerenone
  • Home blood pressure
  • Mineralocorticoid receptor blocker
  • Nocturnal hypertension
  • Uncontrolled hypertension

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