Evidence map›Paper›PMID 39039285›Full record

Trial reportHypertension research : official journal of the Japanese Society of Hypertension2024

Home blood pressure-lowering effect of a non-steroidal mineralocorticoid receptor blocker, esaxerenone, versus trichlormethiazide for uncontrolled hypertension: the EXCITE-HT randomized controlled study.

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 StudyComparative Study
In one paragraph

Trial report in Hypertension research : official journal of the Japanese Society of Hypertension, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
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  5. Trial
  6. Article
  7. Article
  8. Breakthrough drugs in the treatment of hypertension-related disease.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Aldosterone-mineralocorticoid receptor interactions: new insights and therapeutic perspectives in primary aldosteronism.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  14. Article
  15. The Japanese Society of Hypertension Guidelines for the management of elevated blood pressure and hypertension 2025 (JSH2025).Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Emerging therapeutic frontiers in hypertension management.Frontiers in cardiovascular medicine · 2025
    Review
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.
Shizuo KajiyamaKajiyama Clinic, Kyoto, Kyoto, Japan.
Hidenori IshidaAkaicho Clinic, Chiba, Chiba, Japan.
Enyu ImaiNakayamadera Imai Clinic, Takarazuka, Hyogo, Japan.
Yusuke EbeEbe Clinic, Nagaoka, Niigata, Japan.
Mitsuru OhishiDepartment of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Kagoshima, Japan.
Tomohiro KatsuyaKatsuya Clinic, Amagasaki, Hyogo, 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.
Tatsuo ShimosawaDepartment of Clinical Laboratory, School of Medicine, International University of Health and Welfare, Narita, Chiba, Japan.
EXCITE-HT investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The EXCITE-HT study aimed to evaluate the efficacy and safety of esaxerenone versus thiazide diuretics (trichlormethiazide) as second-line treatment for Japanese patients with uncontrolled essential hypertension. This was a 12-week, multicenter, randomized, open-label, parallel-group study. The non-inferiority of esaxerenone to trichlormethiazide was confirmed if the upper limit of the two-sided 95% confidence interval (CI) for the difference in systolic blood pressure (SBP)/diastolic blood pressure (DBP) change between groups was below 3.9/2.1 mmHg. A total of 295 and 290 patients were included in the esaxerenone and trichlormethiazide groups, respectively. The non-inferiority of esaxerenone to trichlormethiazide was demonstrated: least squares mean change differences in morning home SBP/DBP at end of treatment (EOT) were -2.2 (95% CI, -3.6, -0.8) mmHg for SBP/-0.6 (-1.4, 0.2) mmHg for DBP. Morning home, bedtime home, and office BP significantly decreased (all p < 0.001) from baseline to EOT in both groups. The urinary albumin-to-creatinine ratio and N-terminal pro-brain natriuretic peptide level decreased from baseline to Week 12 in both groups, with no notable intergroup difference. Serum potassium elevations occurred more frequently with esaxerenone, while serum potassium reductions occurred more with trichlormethiazide. Uric acid elevations were observed in both groups, but more frequently with trichlormethiazide than esaxerenone. No cases of gout occurred in this study. Reductions in estimated glomerular filtration rate were similarly observed in both groups. EXCITE-HT is the first randomized controlled study to demonstrate evidence that esaxerenone is non-inferior to trichlormethiazide as second-line treatment for Japanese patients with uncontrolled essential hypertension, with no new safety concerns. The EXCITE-HT study demonstrated the non-inferiority of esaxerenone to trichlormethiazide in its morning home blood pressure lowering effect and safety profile in Japanese patients with uncontrolled essential hypertension who were previously treated with an angiotensin II receptor blocker or calcium channel blocker.

Indexed as

Antihypertensive AgentsBlood PressureHypertensionMineralocorticoid Receptor AntagonistsSulfonesTrichlormethiazideAgedBlood Pressure Monitoring, AmbulatoryEssential HypertensionFemaleHumansMaleMiddle AgedPyrrolesTreatment OutcomeAntihypertensive AgentsesaxerenoneMineralocorticoid Receptor AntagonistsPyrrolesSulfonesTrichlormethiazideBlood pressureEsaxerenoneEssential hypertensionJapanTrichlormethiazide

Identifiers

PMID39039285
PMCPMC11374750

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.