Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment

• Published in: Scientific reports Vol. 14; no. 1; pp. 22940 - 12
• Main Authors: Soh, Moon-Seung, Won, Kyung-heon, Kim, Jae-Joong, Lee, Sung Yun, Hyon, Min Su, Youn, Ho-Joong, Rha, Seung-Woon, Kim, Doo-Il, Ahn, Youngkeun, Kim, Byung Jin, Choi, Dong-Ju, Park, Jong-Seon, Kim, Dae-Kyung, Park, Woo-Jung, Lim, Hong-Seok, Tahk, Seung-Jea
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 03.10.2024; Nature Publishing Group; Nature Portfolio
• Subjects: 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; Amlodipine; Antihypertensive; Blood pressure; HTN; Candesartan Cilexetil; Angiotensin receptor blocker
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-024-74003-5

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.