Comparison of two single-pill dual combination antihypertensive therapies in Chinese patients : a randomized, controlled trial

© 2024. The Author(s)..

BACKGROUND: Current hypertension guidelines recommend combination of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker with a calcium-channel blocker or thiazide diuretic as initial antihypertensive therapy in patients with monotherapy uncontrolled hypertension. However, to what extent these two different combinations are comparable in blood pressure (BP)-lowering efficacy and safety remains under investigation, especially in the Chinese population. We investigated the BP-lowering efficacy and safety of the amlodipine/benazepril and benazepril/hydrochlorothiazide dual therapies in Chinese patients.

METHODS: In a multi-center, randomized, actively controlled, parallel-group trial, we enrolled patients with stage 1 or 2 hypertension from July 2018 to June 2021 in 20 hospitals and community health centers across China. Of the 894 screened patients, 560 eligible patients were randomly assigned to amlodipine/benazepril 5/10 mg (n = 282) or benazepril/hydrochlorothiazide 10/12.5 mg (n = 278), with 213 and 212 patients, respectively, who completed the study and had a valid repeat ambulatory BP recording during follow-up and were included in the efficacy analysis. The primary outcome was the change from baseline to 24 weeks of treatment in 24-h ambulatory systolic BP. Adverse events including symptoms and clinically significant changes in physical examinations and laboratory findings were recorded for safety analysis.

RESULTS: In the efficacy analysis (n = 425), the primary outcome, 24-h ambulatory systolic BP reduction, was - 13.8 ± 1.2 mmHg in the amlodipine/benazepril group and - 12.3 ± 1.2 mmHg in the benazepril/hydrochlorothiazide group, with a between-group difference of - 1.51 (p = 0.36) mmHg. The between-group differences for major secondary outcomes were - 1.47 (p = 0.18) in 24-h diastolic BP, - 2.86 (p = 0.13) and - 2.74 (p = 0.03) in daytime systolic and diastolic BP, and - 0.45 (p = 0.82) and - 0.93 (p = 0.44) in nighttime systolic and diastolic BP. In the safety analysis (n = 560), the incidence rate of dry cough was significantly lower in the amlodipine/benazepril group than in the benazepril/hydrochlorothiazide group (5.3% vs 10.1%, p = 0.04).

CONCLUSIONS: The amlodipine/benazepril and benazepril/hydrochlorothiazide dual therapies were comparable in ambulatory systolic BP lowering. The former combination, compared with the latter, had a greater BP-lowering effect in the daytime and a lower incidence rate of dry cough.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03682692. Registered on 18 September 2018.

Medienart:	E-Artikel

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	Zur Gesamtaufnahme - volume:22
Enthalten in:	BMC medicine - 22(2024), 1 vom: 24. Jan., Seite 28

Sprache:	Englisch

Beteiligte Personen:

Huang, Qi-Fang [VerfasserIn] Zhang, Di [VerfasserIn] Luo, Yihong [VerfasserIn] Hu, Kun [VerfasserIn] Wu, Qiong [VerfasserIn] Qiu, Hailong [VerfasserIn] Xu, Fei [VerfasserIn] Wang, Mei-Ling [VerfasserIn] Chen, Xin [VerfasserIn] Li, Yan [VerfasserIn] Wang, Ji-Guang [VerfasserIn] ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD) investigators [VerfasserIn]

Links:	Volltext

Themen:	0J48LPH2TH 1J444QC288 Amlodipine Amlodipine/benazepril Antihypertensive Antihypertensive Agents Benazepril/hydrochlorothiazide Hydrochlorothiazide Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Single-pill combination

Anmerkungen:	Date Completed 25.01.2024 Date Revised 12.02.2024 published: Electronic ClinicalTrials.gov: NCT03682692 Citation Status MEDLINE

doi:	10.1186/s12916-023-03244-4

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	NLM367534401