Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study)
ABSTRACT Sacubitril/valsartan, an angiotensin receptor‐neprilysin inhibitor, has demonstrated a superior blood pressure‐lowering effect compared with renin‐angiotensin system inhibitors in several clinical trials. However, there has been no available evidence on the comparison between sacubitril/val...
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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.14938 |
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| author | Koichi Yamamoto Daisuke Yarimizu Ayano Shimanishi Shunsuke Eguchi Kazuma Iekushi Yoichi Takami Yoichi Nozato Kazuomi Kario Hiromi Rakugi |
| author_facet | Koichi Yamamoto Daisuke Yarimizu Ayano Shimanishi Shunsuke Eguchi Kazuma Iekushi Yoichi Takami Yoichi Nozato Kazuomi Kario Hiromi Rakugi |
| author_sort | Koichi Yamamoto |
| collection | DOAJ |
| description | ABSTRACT Sacubitril/valsartan, an angiotensin receptor‐neprilysin inhibitor, has demonstrated a superior blood pressure‐lowering effect compared with renin‐angiotensin system inhibitors in several clinical trials. However, there has been no available evidence on the comparison between sacubitril/valsartan and calcium channel blockers (CCBs), a well‐established class of antihypertensive drugs. In this open‐label, multicenter study, we aimed to demonstrate the efficacy and safety of sacubitril/valsartan versus amlodipine, one of the most widely used CCBs, after 8 weeks of treatment. A total of 359 Japanese patients with essential hypertension (office systolic blood pressure [SBP] ≥ 150 to < 180 mmHg), aged 18–79, were randomly assigned to receive either once‐daily sacubitril/valsartan 200 mg or once‐daily amlodipine 5 mg in a 1:1 allocation ratio. The primary endpoint was the noninferiority of sacubitril/valsartan compared with amlodipine in mean change in 24‐h SBP from baseline to Week 8, followed by a significance test as a secondary endpoint analysis. The mean change in 24‐h SBP in sacubitril/valsartan was noninferior to that in amlodipine (between‐treatment difference −0.62 mmHg [95% confidential interval: −3.23 to 1.98; p = 0.003 for noninferiority; independent t‐test with noninferiority margin 3.0 mmHg]), with no significant difference observed (p = 0.637). There was no significant difference in the incidence of adverse events (AEs). These results suggested that the blood pressure‐lowering effect of sacubitril/valsartan is comparable to that of amlodipine, with no marked differences in tolerability between the two groups. Sacubitril/valsartan, a potent antihypertensive drug comparable to amlodipine, is expected to improve blood pressure control in clinical practice. |
| format | Article |
| id | doaj-art-0c1bd1f0a6434498a18d13a604b61d61 |
| 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-0c1bd1f0a6434498a18d13a604b61d612025-01-31T05:38:37ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762025-01-01271n/an/a10.1111/jch.14938Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study)Koichi Yamamoto0Daisuke Yarimizu1Ayano Shimanishi2Shunsuke Eguchi3Kazuma Iekushi4Yoichi Takami5Yoichi Nozato6Kazuomi Kario7Hiromi Rakugi8Department of Geriatric and General Medicine Osaka University Graduate School of Medicine Osaka JapanMedical Affairs, Novartis Pharma K.K. Tokyo JapanMedical Affairs, Novartis Pharma K.K. Tokyo JapanMedical Affairs, Novartis Pharma K.K. Tokyo JapanMedical Affairs, Novartis Pharma K.K. Tokyo JapanDepartment of Geriatric and General Medicine Osaka University Graduate School of Medicine Osaka JapanDepartment of Geriatric and General Medicine Osaka University Graduate School of Medicine Osaka JapanDivision of Cardiovascular Medicine Department of Medicine Jichi Medical University School of Medicine Tochigi JapanOsaka Rosai Hospital Osaka JapanABSTRACT Sacubitril/valsartan, an angiotensin receptor‐neprilysin inhibitor, has demonstrated a superior blood pressure‐lowering effect compared with renin‐angiotensin system inhibitors in several clinical trials. However, there has been no available evidence on the comparison between sacubitril/valsartan and calcium channel blockers (CCBs), a well‐established class of antihypertensive drugs. In this open‐label, multicenter study, we aimed to demonstrate the efficacy and safety of sacubitril/valsartan versus amlodipine, one of the most widely used CCBs, after 8 weeks of treatment. A total of 359 Japanese patients with essential hypertension (office systolic blood pressure [SBP] ≥ 150 to < 180 mmHg), aged 18–79, were randomly assigned to receive either once‐daily sacubitril/valsartan 200 mg or once‐daily amlodipine 5 mg in a 1:1 allocation ratio. The primary endpoint was the noninferiority of sacubitril/valsartan compared with amlodipine in mean change in 24‐h SBP from baseline to Week 8, followed by a significance test as a secondary endpoint analysis. The mean change in 24‐h SBP in sacubitril/valsartan was noninferior to that in amlodipine (between‐treatment difference −0.62 mmHg [95% confidential interval: −3.23 to 1.98; p = 0.003 for noninferiority; independent t‐test with noninferiority margin 3.0 mmHg]), with no significant difference observed (p = 0.637). There was no significant difference in the incidence of adverse events (AEs). These results suggested that the blood pressure‐lowering effect of sacubitril/valsartan is comparable to that of amlodipine, with no marked differences in tolerability between the two groups. Sacubitril/valsartan, a potent antihypertensive drug comparable to amlodipine, is expected to improve blood pressure control in clinical practice.https://doi.org/10.1111/jch.14938ambulatory blood pressure monitoringangiotensin receptor‐neprilysin inhibitorcalcium channel blockeressential hypertensionsacubitril/valsartan |
| spellingShingle | Koichi Yamamoto Daisuke Yarimizu Ayano Shimanishi Shunsuke Eguchi Kazuma Iekushi Yoichi Takami Yoichi Nozato Kazuomi Kario Hiromi Rakugi Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) The Journal of Clinical Hypertension ambulatory blood pressure monitoring angiotensin receptor‐neprilysin inhibitor calcium channel blocker essential hypertension sacubitril/valsartan |
| title | Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) |
| title_full | Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) |
| title_fullStr | Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) |
| title_full_unstemmed | Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) |
| title_short | Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open‐Label, Noninferiority Study (PARASOL Study) |
| title_sort | efficacy and safety of sacubitril valsartan versus amlodipine in japanese patients with essential hypertension a randomized multicenter open label noninferiority study parasol study |
| topic | ambulatory blood pressure monitoring angiotensin receptor‐neprilysin inhibitor calcium channel blocker essential hypertension sacubitril/valsartan |
| url | https://doi.org/10.1111/jch.14938 |
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