Efficacy and safety of standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg in primary hypertension: A randomized, double-blind, active-controlled, multicenter phase 3 trial.
amlodipine
blood pressure
chlorthalidone
telmisartan
triple combination
Journal
Journal of clinical hypertension (Greenwich, Conn.)
ISSN: 1751-7176
Titre abrégé: J Clin Hypertens (Greenwich)
Pays: United States
ID NLM: 100888554
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
03
07
2023
received:
14
05
2023
accepted:
26
07
2023
medline:
13
9
2023
pubmed:
24
8
2023
entrez:
24
8
2023
Statut:
ppublish
Résumé
The authors evaluated the efficacy, safety, and characteristics of patients who respond well to standard dose triple combination therapy including chlorthalidone 25 mg with telmisartan 80 mg plus amlodipine 5 mg in hypertensive patients. This is a multicenter, double-blind, active-controlled, phase 3, randomized trial. Patients are randomized to triple combination (telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg, TEL/AML/CHTD group) or dual combination (telmisartan 40 mg/amlodipine 5 mg, TEL/AML group) treatment and then dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. The primary endpoint is the change of mean sitting systolic blood pressure (MSSBP) at week 8. A Target BP achievement rate, a response rate, and the safety endpoints are also evaluated. Total 374 patients (mean age = 60.9 ± 10.7 years, male = 78.3%) were randomized to the study. The baseline MSSBPs/diastolic BPs were 149.9 ± 12.2/88.5 ± 10.4 mm Hg. After 8 weeks treatment, the change of MSSBPs at week 8 are -19.1 ± 14.9 mm Hg (TEL/AML/CHTD) and -11.4 ± 14.7 mm Hg (TEL/AML) (p < .0001). The achievement rates of target BP (53.8% vs. 37.8%, p = .0017) and responder rate (54.8% vs. 35.6%, p = .0001) at week 8 were significantly higher in TEL/AML/CHTD. There are no serious adverse event and no one discontinued medication due to adverse event. Among the TEL 80/AML5/CHTD25mg treatment group, patients of female or age ≥ 65 years old showed higher rate of target BP achievement than relatively young male. (61.4 vs. 46.8%, p = .042) Our study showed standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg is efficacious and safe in treatment of primary hypertension. Target BP achievement with triple therapy would be facilitated in female or old age.
Identifiants
pubmed: 37614053
doi: 10.1111/jch.14707
pmc: PMC10497032
doi:
Substances chimiques
Telmisartan
U5SYW473RQ
Chlorthalidone
Q0MQD1073Q
Amlodipine
1J444QC288
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase III
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
817-827Informations de copyright
© 2023 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.
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