Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment
Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexe...
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| Published in | Scientific reports Vol. 14; no. 1; pp. 22940 - 12 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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London
Nature Publishing Group UK
03.10.2024
Nature Publishing Group Nature Portfolio |
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| Online Access | Get full text |
| ISSN | 2045-2322 2045-2322 |
| DOI | 10.1038/s41598-024-74003-5 |
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| Abstract | Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (
p
< 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (
p
< 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (
p
= 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. |
|---|---|
| AbstractList | Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (
p
< 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (
p
< 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (
p
= 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. Abstract Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone.Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone. |
| ArticleNumber | 22940 |
| Author | Lee, Sung Yun Tahk, Seung-Jea Ahn, Youngkeun Youn, Ho-Joong Kim, Dae-Kyung Park, Woo-Jung Park, Jong-Seon Rha, Seung-Woon Soh, Moon-Seung Kim, Byung Jin Choi, Dong-Ju Kim, Doo-Il Kim, Jae-Joong Won, Kyung-heon Hyon, Min Su Lim, Hong-Seok |
| Author_xml | – sequence: 1 givenname: Moon-Seung surname: Soh fullname: Soh, Moon-Seung organization: Department of Cardiology, Ajou University School of Medicine – sequence: 2 givenname: Kyung-heon surname: Won fullname: Won, Kyung-heon organization: Department of Internal Medicine, Seoul Medical Center – sequence: 3 givenname: Jae-Joong surname: Kim fullname: Kim, Jae-Joong organization: Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine – sequence: 4 givenname: Sung Yun surname: Lee fullname: Lee, Sung Yun organization: Department of Cardiology, Seoul Medical Center – sequence: 5 givenname: Min Su surname: Hyon fullname: Hyon, Min Su organization: Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Hospital – sequence: 6 givenname: Ho-Joong surname: Youn fullname: Youn, Ho-Joong organization: Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea – sequence: 7 givenname: Seung-Woon surname: Rha fullname: Rha, Seung-Woon organization: Division of Cardiology, Korea University Guro Hospital – sequence: 8 givenname: Doo-Il surname: Kim fullname: Kim, Doo-Il organization: Division of Cardiology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine – sequence: 9 givenname: Youngkeun surname: Ahn fullname: Ahn, Youngkeun organization: Department of Cardiology, Chonnam National University Hospital – sequence: 10 givenname: Byung Jin surname: Kim fullname: Kim, Byung Jin organization: Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine – sequence: 11 givenname: Dong-Ju surname: Choi fullname: Choi, Dong-Ju organization: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital – sequence: 12 givenname: Jong-Seon surname: Park fullname: Park, Jong-Seon organization: Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital – sequence: 13 givenname: Dae-Kyung surname: Kim fullname: Kim, Dae-Kyung organization: Division of Cardiology, Department of Internal Medicine, Inje University Busan Paik Hospital – sequence: 14 givenname: Woo-Jung surname: Park fullname: Park, Woo-Jung organization: Division of Cardiology, Hallym University Sacred Heart Hospital – sequence: 15 givenname: Hong-Seok surname: Lim fullname: Lim, Hong-Seok email: camdhslim@ajou.ac.kr organization: Department of Cardiology, Ajou University School of Medicine – sequence: 16 givenname: Seung-Jea surname: Tahk fullname: Tahk, Seung-Jea email: sjtahk@gmail.com organization: Department of Cardiology, Ajou University School of Medicine |
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| Cites_doi | 10.1056/NEJMoa1511939 10.2165/00044011-200929070-00001 10.1185/03007995.2010.487391 10.1136/bmj.b5465 10.1002/ejhf.1149 10.1586/erc.12.34 10.1186/s40885-023-00243-8 10.1097/HJH.0000000000003480 10.1185/03007990903251193 10.1093/eurheartj/ehy504 10.1136/bmj.321.7274.1440 10.1016/S0140-6736(02)11911-8 10.1016/S0140-6736(03)14282-1 10.1161/CIRCULATIONAHA.108.830299 10.1016/j.clinthera.2011.11.007 10.1586/erc.11.90 10.3109/10641963.2012.732641 10.1016/j.amjcard.2010.05.007 10.1007/s12325-010-0002-0 10.1161/HYPERTENSIONAHA.116.08729 10.1159/000175050 10.1161/01.STR.0000075777.18006.89 10.1056/NEJMoa2111437 10.1016/S0140-6736(15)01225-8 10.1161/01.CIR.0000146819.43235.A9 10.1161/HYP.0000000000000076 10.1097/HJH.0000000000002453 |
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| Keywords | Amlodipine Antihypertensive Blood pressure HTN Candesartan Cilexetil Angiotensin receptor blocker |
| Language | English |
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| SubjectTerms | 692/308/153 692/4019 692/699/75/243 Adult Aged Amlodipine Amlodipine - administration & dosage Amlodipine - adverse effects Amlodipine - therapeutic use Angiotensin receptor blocker Antihypertensive Antihypertensive Agents - administration & dosage Antihypertensive Agents - adverse effects Antihypertensive Agents - therapeutic use Antihypertensives Benzimidazoles - administration & dosage Benzimidazoles - adverse effects Benzimidazoles - therapeutic use Biphenyl Compounds - administration & dosage Biphenyl Compounds - adverse effects Biphenyl Compounds - therapeutic use Blood pressure Blood Pressure - drug effects Candesartan Cilexetil Cardiovascular system Clinical trials Double-Blind Method Drug Therapy, Combination Essential Hypertension - drug therapy Female HTN Humanities and Social Sciences Humans Hypertension Hypertension - drug therapy Male Middle Aged multidisciplinary Patients Safety Science Science (multidisciplinary) Tetrazoles - administration & dosage Tetrazoles - adverse effects Tetrazoles - therapeutic use Treatment Outcome |
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| Title | Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment |
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