Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients
Open accessAbstract
BACKGROUND: The optimal combination drug therapy for hypertension is not established, although current U.S. guidelines recommend inclusion of a diuretic. We hypothesized that treatment with the combination of an angiotensin-converting-enzyme (ACE) inhibitor and a dihydropyridine calcium-channel blocker would be more effective in reducing the rate of cardiovascular events than treatment with an ACE inhibitor plus a thiazide diuretic. METHODS: In a randomized, double-blind trial, we assigned 11,506 patients with hypertension who were at high risk for cardiovascular events to receive treatment with either benazepril plus amlodipine or benazepril plus hydrochlorothiazide. The primary end point was the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for angina, resuscitation after sudden cardiac arrest, and coronary revascularization. RESULTS: The baseline characteristics of the two groups were similar. The trial was terminated early after a mean follow-up of 36 months, when the boundary of the prespecified stopping rule was exceeded. Mean blood pressures after dose adjustment were 131.6/73.3 mm Hg in the benazepril-amlodipine group and 132.5/74.4 mm Hg in the benazepril-hydrochlorothiazide group. There were 552 primary-outcome events in the benazepril-amlodipine group (9.6%) and 679 in the benazepril-hydrochlorothiazide group (11.8%), representing an absolute risk reduction with benazepril-amlodipine therapy of 2.2% and a relative risk reduction of 19.6% (hazard ratio, 0.80, 95% confidence interval [CI], 0.72 to 0.90; P<0.001). For the secondary end point of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke, the hazard ratio was 0.79 (95% CI, 0.67 to 0.92; P=0.002). Rates of adverse events were consistent with those observed from clinical experience with the study drugs. CONCLUSIONS: The benazepril-amlodipine combination was superior to the benazepril-hydrochlorothiazide combination in reducing cardiovascular events in patients with hypertension who were at high risk for such events. (ClinicalTrials.gov number, NCT00170950.)
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Trial evidence of outcome reduction has been obtained particularly for the combination of a diuretic with an ACE inhibitor, an angiotensin receptor antagonist, or a calcium antagonist.
“Trial evidence of outcome reduction has been obtained particularly for the combination of a diuretic with an ACE inhibitor or an angiotensin receptor antagonist or calcium antagonist.429,430”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [430]
The higher prevalence of apparent treatment-resistant hypertension among treated hypertensive adults in clinical trials (34%-39%) is likely explained by the selection of patients with demographic and comorbidity characteristics that place them at high risk for the fatal and nonfatal cardiovascular disease outcomes of interest.
“The higher prevalence of aTRH among treated hypertensive adults in clinical trials (34%−39%) is likely explained by the selection of patients with demographic and comorbidity characteristics that place them at high risk for the fatal and nonfatal CVD outcomes of interest.21–26”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [24]
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- Authors
- Jamerson, K., Weber, M. A., Bakris, G. L., Dahlöf, B., Pitt, B., Shi, V., Hester, A., Gupte, J., Gatlin, M., & Velazquez, E. J.
- Affiliations
- Michigan Medicine (US)
- State University of New York (US)
- University of Chicago (US)
- Sahlgrenska University Hospital (SE)
- Duke University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-12-04
- Volume
- 359
- Issue
- 23
- Pages
- 2417-2428
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2110880027
- Cited by
- 2,065
- References
- 21
- Citations by year
- 2026: 32 · 2025: 45 · 2024: 56 · 2023: 64 · 2022: 63 · 2021: 55 · 2020: 72 · 2019: 75 · 2018: 90 · 2017: 110 · 2016: 113 · 2015: 117 · 2014: 145 · 2013: 188 · 2012: 205
- FWCI
- 152.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Utah
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- hypertension, combination antihypertensive therapy, benazepril, amlodipine, hydrochlorothiazide, ACE inhibitors, calcium channel blockers, thiazide diuretics, cardiovascular events, cardiovascular mortality, myocardial infarction, stroke, high-risk patients, blood pressure control, early trial termination, cardiovascular risk reduction, adverse events
- MeSH terms
- Aged, Angiotensin-Converting Enzyme Inhibitors, Antihypertensive Agents, Benzazepines, Blood Pressure, Calcium Channel Blockers, Cardiovascular Diseases, Diuretics, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Hydrochlorothiazide, Hypertension, Male, Middle Aged, Risk, Amlodipine, Kaplan-Meier Estimate
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