Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT)
ABSTRACT Angiotensin II receptor blockers (ARBs) and calcium channel blockers (CCBs) are commonly prescribed as first‐ and second‐line treatments for older Japanese patients with hypertension. However, due to age‐related decline in renin activity, the effectiveness of ARBs may decrease. This highlig...
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| Format: | Article |
| Language: | English |
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Wiley
2025-01-01
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| Series: | The Journal of Clinical Hypertension |
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| Online Access: | https://doi.org/10.1111/jch.14947 |
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| author | Kazuomi Kario Tomohiro Katsuya Tatsuo Shimosawa Takashi Taguchi Ayumi Tanabe Mitsuru Ohishi the ESCORT‐HT investigators |
| author_facet | Kazuomi Kario Tomohiro Katsuya Tatsuo Shimosawa Takashi Taguchi Ayumi Tanabe Mitsuru Ohishi the ESCORT‐HT investigators |
| author_sort | Kazuomi Kario |
| collection | DOAJ |
| description | ABSTRACT Angiotensin II receptor blockers (ARBs) and calcium channel blockers (CCBs) are commonly prescribed as first‐ and second‐line treatments for older Japanese patients with hypertension. However, due to age‐related decline in renin activity, the effectiveness of ARBs may decrease. This highlights the need for other antihypertensive agents to be used in combination with CCBs to replace ARBs for more effective blood pressure (BP) control. The ESCORT‐HT study is a multicenter, randomized, controlled, open‐label, parallel‐group study with a 4‐week run‐in period and 12‐week treatment period. This study aims to evaluate the efficacy of esaxerenone as a second‐line treatment for hypertension and to determine whether its BP‐lowering effect is noninferior to that of ARBs in older patients with uncontrolled hypertension on CCB monotherapy. The safety profiles of esaxerenone and ARBs will also be evaluated. Patients will be randomly assigned in a 1:1 ratio to receive either esaxerenone or an ARB. The primary efficacy endpoint will be the change from baseline in morning home systolic BP at the end of the treatment period. The BP‐lowering effect of esaxerenone will be considered noninferior to that of ARBs if the upper limit of the two‐sided 95% confidence interval (CI) for the difference in systolic BP change between esaxerenone and ARB is <3.8 mmHg, and will be considered superior if the upper limit of the two‐sided 95% CI is <0. The findings may elucidate the possible benefits of earlier use of mineralocorticoid receptor blockers in combination with CCBs in older patients with essential hypertension. |
| format | Article |
| id | doaj-art-a72b545046a44e16820a4095594cd3c6 |
| institution | Kabale University |
| issn | 1524-6175 1751-7176 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj-art-a72b545046a44e16820a4095594cd3c62025-01-31T05:38:36ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762025-01-01271n/an/a10.1111/jch.14947Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT)Kazuomi Kario0Tomohiro Katsuya1Tatsuo Shimosawa2Takashi Taguchi3Ayumi Tanabe4Mitsuru Ohishi5the ESCORT‐HT investigatorsDivision of Cardiovascular Medicine Department of Medicine Jichi Medical University School of Medicine Shimotsuke Tochigi JapanKatsuya Clinic Amagasaki Hyogo JapanDepartment of Clinical Laboratory School of Medicine International University of Health and Welfare Narita Chiba JapanPrimary Medical Science Department Medical Affairs Division Daiichi Sankyo Co., Ltd Chuo‐ku Tokyo JapanData Intelligence Department Daiichi Sankyo Co., Ltd. Shinagawa‐ku Tokyo JapanDepartment of Cardiovascular Medicine and Hypertension Graduate School of Medical and Dental Sciences Kagoshima University Kagoshima Kagoshima JapanABSTRACT Angiotensin II receptor blockers (ARBs) and calcium channel blockers (CCBs) are commonly prescribed as first‐ and second‐line treatments for older Japanese patients with hypertension. However, due to age‐related decline in renin activity, the effectiveness of ARBs may decrease. This highlights the need for other antihypertensive agents to be used in combination with CCBs to replace ARBs for more effective blood pressure (BP) control. The ESCORT‐HT study is a multicenter, randomized, controlled, open‐label, parallel‐group study with a 4‐week run‐in period and 12‐week treatment period. This study aims to evaluate the efficacy of esaxerenone as a second‐line treatment for hypertension and to determine whether its BP‐lowering effect is noninferior to that of ARBs in older patients with uncontrolled hypertension on CCB monotherapy. The safety profiles of esaxerenone and ARBs will also be evaluated. Patients will be randomly assigned in a 1:1 ratio to receive either esaxerenone or an ARB. The primary efficacy endpoint will be the change from baseline in morning home systolic BP at the end of the treatment period. The BP‐lowering effect of esaxerenone will be considered noninferior to that of ARBs if the upper limit of the two‐sided 95% confidence interval (CI) for the difference in systolic BP change between esaxerenone and ARB is <3.8 mmHg, and will be considered superior if the upper limit of the two‐sided 95% CI is <0. The findings may elucidate the possible benefits of earlier use of mineralocorticoid receptor blockers in combination with CCBs in older patients with essential hypertension.https://doi.org/10.1111/jch.14947angiotensin II receptor blockersesaxerenonehypertensionmineralocorticoid receptor blockersrandomized comparative study |
| spellingShingle | Kazuomi Kario Tomohiro Katsuya Tatsuo Shimosawa Takashi Taguchi Ayumi Tanabe Mitsuru Ohishi the ESCORT‐HT investigators Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) The Journal of Clinical Hypertension angiotensin II receptor blockers esaxerenone hypertension mineralocorticoid receptor blockers randomized comparative study |
| title | Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) |
| title_full | Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) |
| title_fullStr | Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) |
| title_full_unstemmed | Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) |
| title_short | Rationale and Design of a Randomized, Open‐Label, Parallel‐Group Study of Esaxerenone Versus Angiotensin Receptor Blockers in Older Patients With Uncontrolled Hypertension on Calcium Channel Blocker Monotherapy (ESCORT‐HT) |
| title_sort | rationale and design of a randomized open label parallel group study of esaxerenone versus angiotensin receptor blockers in older patients with uncontrolled hypertension on calcium channel blocker monotherapy escort ht |
| topic | angiotensin II receptor blockers esaxerenone hypertension mineralocorticoid receptor blockers randomized comparative study |
| url | https://doi.org/10.1111/jch.14947 |
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