Evidence map›Paper›PMID 40189653›Full record

Trial reportHypertension research : official journal of the Japanese Society of Hypertension2025

Home blood pressure-lowering effect of esaxerenone vs trichlormethiazide for uncontrolled hypertension: a prespecified subanalysis of the EXCITE-HT randomized controlled study by age subgroup.

Kazuomi Kario, Hiroyuki Ohbayashi, Masami Hashimoto, Naoki Itabashi, Mitsutoshi Kato, Kazuaki Uchiyama, Kunio Hirano, Noriko Nakamura, Takahide Miyamoto, Hirotaka Nagashima and 10 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hypertension research : official journal of the Japanese Society of Hypertension, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
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  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Kazuomi KarioDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan. kkario@jichi.ac.jp.
Hiroyuki OhbayashiTohno Chuo Clinic, Mizunami, Gifu, Japan.
Masami HashimotoHashimoto Kidney Clinic, Fukuyama, Hiroshima, Japan.
Naoki ItabashiItabashi Diabetes and Dermatology Medical Clinic, Koga, Ibaraki, Japan.
Mitsutoshi KatoKato Clinic of Internal Medicine, Katsushika-ku, Tokyo, Japan.
Kazuaki UchiyamaUchiyama Clinic, Joetsu, Niigata, Japan.
Kunio HiranoHirano Clinic, Morioka, Iwate, Japan.
Noriko NakamuraPrimula Clinic, Kagoshima, Kagoshima, Japan.
Takahide MiyamotoMiyamoto Clinic of Internal Medicine, Matsumoto, Nagano, Japan.
Hirotaka NagashimaTokyo Center Clinic, Chuo-ku, Tokyo, Japan.
Hidenori IshidaAkaicho Clinic, Chiba, Chiba, Japan.
Yusuke EbeEbe Clinic, Nagaoka, Niigata, Japan.
Tsuguru HattaHatta Medical Clinic, Kyoto, Kyoto, Japan.
Toshiki FukuiOlive Takamatsu Medical Clinic, Takamatsu, Kagawa, Japan.
Tomohiro KatsuyaKatsuya Clinic, Amagasaki, Hyogo, Japan.
Tatsuo ShimosawaDepartment of Clinical Laboratory, School of Medicine, International University of Health and Welfare, Narita, Chiba, Japan.
Takashi TaguchiPrimary Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Chuo-ku, Tokyo, Japan.
Ayumi TanabeData Intelligence Department, Daiichi Sankyo Co., Ltd., Shinagawa-ku, Tokyo, Japan.
Mitsuru OhishiDepartment of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Kagoshima, Japan.
EXCITE-HT investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This predefined subanalysis of the multicenter, randomized, open-label, parallel-group EXCITE-HT study aimed to determine whether the comparative efficacy and safety of esaxerenone and trichlormethiazide differs with age. Patients were divided into two age subgroups (<65 and ≥65 years). The non-inferiority of esaxerenone to trichlormethiazide was assessed based on the upper limit of the two-sided 95% confidence interval (CI) for the difference in systolic/diastolic blood pressure (SBP/DBP) changes. Esaxerenone was considered non-inferior if this value was <3.9/ < 2.1 mmHg; if it was <0 mmHg, esaxerenone was considered superior in its BP-lowering effect. The results showed that the least squares mean changes in morning home SBP/DBP from baseline to the end of treatment (primary endpoint) were -9.5/-5.7 with esaxerenone and -8.2/-4.9 mmHg with trichloromethiazide (between-group difference: -1.3 [95% CI, -3.3, 0.8]/-0.8 [ - 2.1, 0.5] mmHg) in the subgroup aged <65 years. These changes were -14.6/-7.2 and -11.5/-6.7 (-3.0 [-4.9, -1.2]/-0.5 [-1.5, 0.5] mmHg) in the subgroup aged ≥65 years. The incidences of serum potassium level ≥5.5 mEq/L were 2.2% and 1.9% in the esaxerenone-treated subgroups aged <65 and ≥65 years, respectively. In conclusion, esaxerenone achieved the pre-defined non-inferiority margin to trichlormethiazide in its BP-lowering effect regardless of age. In patients aged <65 years, esaxerenone achieved the non-inferiority margin to trichlormethiazide in lowering both SBP and DBP. In patients aged ≥65 years, esaxerenone was superior to trichlormethiazide in lowering SBP and achieved the non-inferiority margin to trichlormethiazide in lowering DBP. The impact of esaxerenone on serum potassium levels did not show a specific age-related effect. A subgroup analysis of the EXCITE-HT study according to age (<65 and ≥65 years) showed that esaxerenone achieved the pre-defined non-inferiority margin to trichlormethiazide in its BP-lowering effect regardless of age. In patients aged ≥65 years, esaxerenone achieved the superiority margin to trichlormethiazide in lowering SBP.

Indexed as

Antihypertensive AgentsBlood PressureHypertensionSpiro CompoundsTrichlormethiazideAdultAgedAge FactorsBlood Pressure Monitoring, AmbulatoryFemaleHumansMaleMiddle AgedPyrrolesSulfonesTreatment OutcomeAntihypertensive AgentsesaxerenonePyrrolesSpiro CompoundsSulfonesTrichlormethiazideAgeEsaxerenoneEssential hypertensionTrichlormethiazide

Identifiers

PMID40189653
PMCPMC11972961

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.