Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study
Abstract The next‐generation mineralocorticoid receptor blocker (MRB) esaxerenone has favorable antihypertensive effects in patients who do not respond to treatment with first‐line antihypertensive agents and may be beneficial as a second‐line treatment. However, MRBs are currently considered a four...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-09-01
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| Series: | The Journal of Clinical Hypertension |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jch.14705 |
| _version_ | 1797645223556284416 |
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| author | Kazuomi Kario Mitsuru Ohishi Tomohiro Katsuya Takashi Taguchi Ayumi Tanabe Kotaro Sugimoto Tatsuo Shimosawa |
| author_facet | Kazuomi Kario Mitsuru Ohishi Tomohiro Katsuya Takashi Taguchi Ayumi Tanabe Kotaro Sugimoto Tatsuo Shimosawa |
| author_sort | Kazuomi Kario |
| collection | DOAJ |
| description | Abstract The next‐generation mineralocorticoid receptor blocker (MRB) esaxerenone has favorable antihypertensive effects in patients who do not respond to treatment with first‐line antihypertensive agents and may be beneficial as a second‐line treatment. However, MRBs are currently considered a fourth‐line treatment as there is no clinical evidence comparing the efficacy of esaxerenone with other classes of antihypertensive agents. The multicenter, randomized, open‐label, parallel‐group EXCITE‐HT study will evaluate the efficacy and safety of esaxerenone as a second‐line agent in the treatment of Japanese patients with uncontrolled essential hypertension. After a 4‐week run‐in period, patients will receive either esaxerenone or trichlormethiazide for 12 weeks per the package insert and the Japanese Society of Hypertension Guidelines for the Management of Hypertension. At Weeks 4 and 8, the dose of esaxerenone or trichlormethiazide may be increased. Blood pressure (home [morning and bedtime] and office), serum biomarkers, and urinary biomarkers will be measured. The primary efficacy endpoint is the change from baseline in morning home systolic blood pressure/diastolic blood pressure to the end of treatment. The EXCITE‐HT study is expected to validate the non‐inferiority of esaxerenone to trichlormethiazide and provide the first evidence for the early use of esaxerenone as a second‐line agent in the treatment of Japanese patients with uncontrolled essential hypertension instead of its current use as a fourth‐line agent. |
| first_indexed | 2024-03-11T14:43:15Z |
| format | Article |
| id | doaj.art-4f1daafbd74d4cb68c4d360d55611a43 |
| institution | Directory Open Access Journal |
| issn | 1524-6175 1751-7176 |
| language | English |
| last_indexed | 2024-03-11T14:43:15Z |
| publishDate | 2023-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj.art-4f1daafbd74d4cb68c4d360d55611a432023-10-30T13:26:20ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762023-09-0125986186710.1111/jch.14705Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT studyKazuomi Kario0Mitsuru Ohishi1Tomohiro Katsuya2Takashi Taguchi3Ayumi Tanabe4Kotaro Sugimoto5Tatsuo Shimosawa6Division of Cardiovascular Medicine Department of Medicine Jichi Medical University School of Medicine TochigiJapanDepartment of Cardiovascular Medicine and Hypertension Graduate School of Medical and Dental Sciences Kagoshima University KagoshimaJapanKatsuya Clinic HyogoJapanPrimary Medical Science Department Daiichi Sankyo Co., Ltd TokyoJapanData Intelligence Department Daiichi Sankyo Co., Ltd. TokyoJapanPrimary Medical Science Department Daiichi Sankyo Co., Ltd TokyoJapanDepartment of Clinical Laboratory School of Medicine International University of Health and Welfare ChibaJapanAbstract The next‐generation mineralocorticoid receptor blocker (MRB) esaxerenone has favorable antihypertensive effects in patients who do not respond to treatment with first‐line antihypertensive agents and may be beneficial as a second‐line treatment. However, MRBs are currently considered a fourth‐line treatment as there is no clinical evidence comparing the efficacy of esaxerenone with other classes of antihypertensive agents. The multicenter, randomized, open‐label, parallel‐group EXCITE‐HT study will evaluate the efficacy and safety of esaxerenone as a second‐line agent in the treatment of Japanese patients with uncontrolled essential hypertension. After a 4‐week run‐in period, patients will receive either esaxerenone or trichlormethiazide for 12 weeks per the package insert and the Japanese Society of Hypertension Guidelines for the Management of Hypertension. At Weeks 4 and 8, the dose of esaxerenone or trichlormethiazide may be increased. Blood pressure (home [morning and bedtime] and office), serum biomarkers, and urinary biomarkers will be measured. The primary efficacy endpoint is the change from baseline in morning home systolic blood pressure/diastolic blood pressure to the end of treatment. The EXCITE‐HT study is expected to validate the non‐inferiority of esaxerenone to trichlormethiazide and provide the first evidence for the early use of esaxerenone as a second‐line agent in the treatment of Japanese patients with uncontrolled essential hypertension instead of its current use as a fourth‐line agent.https://doi.org/10.1111/jch.14705esaxerenonehypertensionmineralocorticoid receptor blockersrandomized comparative studytrichlormethiazide |
| spellingShingle | Kazuomi Kario Mitsuru Ohishi Tomohiro Katsuya Takashi Taguchi Ayumi Tanabe Kotaro Sugimoto Tatsuo Shimosawa Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study The Journal of Clinical Hypertension esaxerenone hypertension mineralocorticoid receptor blockers randomized comparative study trichlormethiazide |
| title | Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study |
| title_full | Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study |
| title_fullStr | Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study |
| title_full_unstemmed | Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study |
| title_short | Rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension: EXCITE‐HT study |
| title_sort | rationale and design of a multicenter randomized study comparing the efficacy and safety of esaxerenone versus trichlormethiazide in patients with uncontrolled essential hypertension excite ht study |
| topic | esaxerenone hypertension mineralocorticoid receptor blockers randomized comparative study trichlormethiazide |
| url | https://doi.org/10.1111/jch.14705 |
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