Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment.
Humans
Amlodipine
/ administration & dosage
Benzimidazoles
/ administration & dosage
Female
Male
Middle Aged
Antihypertensive Agents
/ administration & dosage
Biphenyl Compounds
/ therapeutic use
Tetrazoles
/ administration & dosage
Hypertension
/ drug therapy
Double-Blind Method
Blood Pressure
/ drug effects
Aged
Drug Therapy, Combination
Treatment Outcome
Essential Hypertension
/ drug therapy
Adult
Amlodipine
Angiotensin receptor blocker
Antihypertensive
Blood pressure
Candesartan Cilexetil
HTN
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
03 Oct 2024
03 Oct 2024
Historique:
received:
19
05
2024
accepted:
23
09
2024
medline:
3
10
2024
pubmed:
3
10
2024
entrez:
2
10
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 39358448
doi: 10.1038/s41598-024-74003-5
pii: 10.1038/s41598-024-74003-5
doi:
Substances chimiques
Amlodipine
1J444QC288
candesartan cilexetil
R85M2X0D68
Benzimidazoles
0
Antihypertensive Agents
0
Biphenyl Compounds
0
Tetrazoles
0
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase III
Langues
eng
Sous-ensembles de citation
IM
Pagination
22940Informations de copyright
© 2024. The Author(s).
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