New England Journal of Medicine DECEMBER 04, 2008

Benazepril plus Amlodipine or Hydrochlorothiazide for Hypertension in High-Risk Patients

Kenneth Jamerson, Michael A. Weber, George L. Bakris, Björn Dahlöf, Bertram Pitt, Victor Shi, Allen Hester, Jitendra Gupte, Marjorie Gatlin, Eric J. Velazquez, et al.

Bottom Line

In patients with high-risk hypertension, the combination of the ACE inhibitor benazepril with the calcium channel blocker amlodipine was superior to the combination of benazepril with the diuretic hydrochlorothiazide in reducing major cardiovascular events.

Key Findings

1. The primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for angina, resuscitated sudden cardiac arrest, and coronary revascularization occurred in 9.6% of the benazepril-amlodipine group compared with 11.8% in the benazepril-hydrochlorothiazide group (HR 0.80; 95% CI, 0.72-0.90; P<0.001).
2. The benefit was driven primarily by a significant reduction in the rate of fatal and nonfatal myocardial infarction (HR 0.78; 95% CI, 0.62-0.99; P=0.04).
3. There was no statistically significant difference between the two groups regarding cardiovascular death alone (HR 0.80; 95% CI, 0.62-1.03; P=0.08).
4. Blood pressure control rates were high in both groups, though the benazepril-amlodipine combination achieved slightly lower mean systolic blood pressure (a difference of 0.9 mm Hg) compared to the benazepril-hydrochlorothiazide combination (P<0.001).

Study Design

Design
RCT
Double-Blind
Sample
11,506
Patients
Duration
36 mo
Median
Setting
Multicenter, International
Population Patients with hypertension who were at high risk for cardiovascular events (defined as having established cardiovascular disease, target organ damage, or diabetes mellitus).
Intervention Fixed-dose combination of benazepril (20 mg) and amlodipine (5 mg) daily, titrated as needed.
Comparator Fixed-dose combination of benazepril (20 mg) and hydrochlorothiazide (12.5 mg) daily, titrated as needed.
Outcome Composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for angina, resuscitation after sudden cardiac arrest, and coronary revascularization.

Study Limitations

The study was terminated early due to reaching a pre-specified efficacy boundary, which may potentially lead to an overestimation of the treatment effect size.
The use of hydrochlorothiazide (12.5-25 mg) rather than more potent thiazide-like diuretics such as chlorthalidone limits the generalizability of these findings when comparing ACE inhibitor combinations against standard-of-care diuretic therapies.
The study design involved industry sponsorship and coordination by Novartis, the manufacturer of the fixed-dose combinations used.
Peripheral edema was significantly more common in the amlodipine-containing arm (31.2%) compared to the hydrochlorothiazide-containing arm (13.4%).

Clinical Significance

The ACCOMPLISH trial challenged the long-standing guideline preference (e.g., JNC-7) for diuretic-based initial combination therapy in hypertension, demonstrating that an ACE inhibitor combined with a calcium channel blocker provides superior cardiovascular protection compared to an ACE inhibitor combined with a thiazide diuretic in high-risk patients.

Historical Context

At the time of publication, many hypertension guidelines recommended initial treatment with a diuretic based heavily on results from the ALLHAT trial. ACCOMPLISH provided pivotal evidence that the choice of second-line agent added to an ACE inhibitor significantly impacts cardiovascular outcomes, leading to a shift in clinical practice toward using RAS blockers with calcium channel blockers in high-risk hypertensive populations.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

What is the physiological rationale for combining an ACE inhibitor with either a calcium channel blocker (CCB) or a thiazide diuretic in the management of hypertension, and how do these mechanisms provide synergy?

Key Response

Both combinations target different pathways of blood pressure regulation. ACE inhibitors block the renin-angiotensin-aldosterone system (RAAS), which promotes vasodilation and reduces sodium retention. Thiazides increase sodium excretion, which often triggers a compensatory rise in renin; adding an ACE inhibitor blunts this compensation. CCBs cause arterial vasodilation; combining them with an ACE inhibitor helps counteract the peripheral edema often caused by CCBs by promoting venous dilation through the RAAS blockade.

Resident
Resident

In a high-risk hypertensive patient with diabetes or established coronary artery disease, how does the ACCOMPLISH trial findings change your first-line choice of dual-combination therapy compared to the older ALLHAT-driven paradigm?

Key Response

The ALLHAT trial previously established chlorthalidone as a cornerstone of therapy. However, ACCOMPLISH specifically compared two combination therapies and found that benazepril/amlodipine was significantly superior to benazepril/HCTZ in reducing major cardiovascular events (20% relative risk reduction), despite similar blood pressure control. This suggests that for high-risk patients, the ACEi/CCB combination should be prioritized over the ACEi/Thiazide combination.

Fellow
Fellow

Considering the ACCOMPLISH trial's results on renal outcomes, how should these findings influence the management of patients with chronic kidney disease (CKD) who require multi-drug therapy?

Key Response

Secondary analyses of ACCOMPLISH demonstrated that the benazepril/amlodipine combination was more effective at slowing the progression of CKD (defined by doubling of serum creatinine or ESRD) than the benazepril/HCTZ combination. This challenges the historical preference for diuretics in CKD management and suggests that CCBs may offer superior nephroprotection when paired with RAAS inhibitors in non-edematous patients.

Attending
Attending

Given that blood pressure reduction was nearly identical in both arms of the ACCOMPLISH trial, what does this trial teach us about the 'pleiotropic' effects of antihypertensive classes and the concept of 'blood-pressure-independent' vascular protection?

Key Response

ACCOMPLISH is a landmark study because it decoupled blood pressure lowering from cardiovascular outcomes. Because the achieved BP was the same but the outcomes differed, it suggests that the amlodipine-based combination may provide superior endothelial protection, reduction in central aortic pressure, or better metabolic neutrality (less hyperglycemia or hypokalemia) compared to the HCTZ-based combination, highlighting that the 'choice' of agent is as critical as the 'target' BP.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The ACCOMPLISH trial was terminated early after an interim analysis by the Data and Safety Monitoring Board. How does early termination for efficacy impact the interpretation of the hazard ratios for the primary endpoint, and what are the statistical risks associated with this decision?

Key Response

Early termination for efficacy can lead to 'over-optimism' or an overestimation of the treatment effect size (hazard ratio). While the p-value was highly significant (p < 0.001), stopping early means the trial potentially captures a random high fluctuation in the benefit, and the confidence intervals might be narrower than if the trial had proceeded to its planned conclusion, necessitating caution when applying these exact effect sizes to cost-benefit models.

Journal Editor
Journal Editor

A critical reviewer might point out that ACCOMPLISH used hydrochlorothiazide (HCTZ) rather than chlorthalidone. How does the choice of the specific diuretic component affect the internal and external validity of the study’s comparison between the CCB and thiazide arms?

Key Response

HCTZ is shorter-acting and potentially less potent than chlorthalidone, which was the diuretic used in the ALLHAT trial. A reviewer would flag that the 'inferiority' of the diuretic arm in ACCOMPLISH might be a reflection of the specific drug (HCTZ) and its 24-hour BP profile rather than a class effect of thiazide-type diuretics, potentially limiting the generalizability of the results to patients on chlorthalidone or indapamide.

Guideline Committee
Guideline Committee

Based on the evidence from ACCOMPLISH, should clinical guidelines (such as ACC/AHA or ESC/ESH) transition from recommending 'any' two-drug combination for Stage 2 hypertension to specifically recommending ACEi/CCB as the preferred initial strategy in high-risk populations?

Key Response

Current ACC/AHA guidelines (2017) recommend both ACEi/CCB and ACEi/Diuretic as Class I, Level A options. However, the ACCOMPLISH data provides the most robust head-to-head evidence of superiority for the CCB combination in preventing CV events. The committee must weigh this against the lower cost and long-standing evidence for thiazides in stroke prevention, but for high-risk patients with CAD or diabetes, ACCOMPLISH provides a strong mandate to prioritize ACEi/CCB as the primary recommendation.

Clinical Landscape

Noteworthy Related Trials

2002

ALLHAT Trial

n = 33,357 · JAMA

Tested

Amlodipine, Lisinopril, or Chlorthalidone

Population

Patients aged 55+ with hypertension and at least one other CHD risk factor

Comparator

Chlorthalidone (primary reference)

Endpoint

Fatal CHD or nonfatal myocardial infarction

Key result: Thiazide-type diuretics were found to be as effective as CCBs or ACE inhibitors in preventing major cardiovascular outcomes.
2005

ASCOT-BPLA Trial

n = 19,257 · Lancet

Tested

Amlodipine (+/- Perindopril) vs Atenolol (+/- Bendroflumethiazide)

Population

Hypertensive patients with at least three CV risk factors

Comparator

Atenolol-based regimen

Endpoint

Nonfatal myocardial infarction and fatal CHD

Key result: Amlodipine-based therapy resulted in superior cardiovascular outcomes compared to the atenolol-based regimen.
2008

ONTARGET Trial

n = 25,620 · NEJM

Tested

Telmisartan, Ramipril, or combination therapy

Population

Patients with vascular disease or high-risk diabetes

Comparator

Ramipril

Endpoint

Composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure

Key result: Telmisartan was non-inferior to ramipril, but the combination of both did not provide additional benefits and caused more adverse events.

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