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Open AccessDOI: pub_80__articleID_236Original Research

Efficacy and Safety of Combined Antihypertensive Therapy in Patients with Coronary Heart Disease: A Randomized Controlled Trial

ZHANG Wei¹,LI Ming¹,WANG Fang¹,et al.Ā¹āœ‰

• Department of Cardiology, Peking Union Medical College Hospital, Beijing, China

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Efficacy and Safety of Combined Antihypertensive Therapy in Patients with Coronary Heart Disease: A Randomized Controlled Trial
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Published In
Chinese Journal of New Drugs
Published:January 15, 2025Edition:Vol 34, Issue 15 • pp. 100-112Citation:ZHANG Wei et al. (2025), Chinese Journal of New Drugs
Impact FactorPremier Chinese Biomedical Journal indexed in SinoBioData: Chinese Journal of New Drugs (äø­å›½ę–°čÆę‚åæ—).

Key Takeaways & Executive Findings

  • •• • Combination therapy (amlodipine 5 mg + perindopril 4 mg) achieved a mean SBP reduction of 23.5 mmHg (from 158.2±12.3 to 134.7±8.9 mmHg) over 24 weeks, significantly greater than monotherapy's 18.2 mmHg (p<0.01), indicating enhanced efficacy for high-risk CHD patients. • • Target BP (<140/90 mmHg) was attained in 82.5% of patients on combination therapy versus 65.0% on monotherapy (p<0.01), a clinically meaningful improvement that could reduce cardiovascular events. • • Adverse event rates were similar (12.5% vs 10.8%, p>0.05), with no serious adverse events, demonstrating that the combination is well-tolerated and safe for long-term use. • • No significant changes in renal function, electrolytes, or liver enzymes were observed, confirming the metabolic neutrality of the regimen, which is crucial for patients with comorbid conditions.

Abstract

This randomized controlled trial evaluated the efficacy and safety of combined antihypertensive therapy in patients with coronary heart disease (CHD) and hypertension. A total of 240 patients were randomized to receive either combination therapy (amlodipine 5 mg plus perindopril 4 mg) or monotherapy (amlodipine 5 mg) for 24 weeks. The primary endpoint was the change in systolic blood pressure (SBP) from baseline to week 24. Secondary endpoints included diastolic blood pressure (DBP), heart rate, adverse events, and laboratory parameters. Results showed that combination therapy reduced SBP by 23.5 mmHg (from 158.2±12.3 to 134.7±8.9 mmHg) compared to 18.2 mmHg (from 157.8±11.9 to 139.6±9.2 mmHg) with monotherapy (p<0.01). DBP reductions were 12.4 mmHg and 9.8 mmHg, respectively (p<0.05). The combination group achieved target BP (<140/90 mmHg) in 82.5% of patients versus 65.0% in the monotherapy group (p<0.01). Adverse events were comparable between groups (12.5% vs 10.8%, p>0.05), with no serious adverse events. Laboratory tests showed no significant changes in renal function, electrolytes, or liver enzymes. In conclusion, combination therapy with amlodipine and perindopril provides superior blood pressure control without increasing adverse events in CHD patients, supporting its use as an effective strategy for hypertension management in this high-risk population.

1. Introduction

Hypertension is a major modifiable risk factor for coronary heart disease (CHD), and optimal blood pressure control is paramount to reducing recurrent cardiovascular events. Despite the availability of multiple antihypertensive classes, a substantial proportion of CHD patients fail to achieve target blood pressure with monotherapy, often due to insufficient efficacy or dose-limiting adverse effects. This therapeutic gap underscores the need for rational combination strategies that maximize blood pressure lowering while minimizing tolerability issues.

The present randomized controlled trial directly addresses this clinical bottleneck by comparing a fixed-dose combination of amlodipine (a calcium channel blocker) and perindopril (an ACE inhibitor) against amlodipine monotherapy in a well-characterized CHD cohort. By leveraging complementary mechanisms of action—vasodilation and neurohormonal modulation—the combination aims to achieve synergistic blood pressure reduction and improved vascular protection. This study provides rigorous evidence on the efficacy, safety, and tolerability of this combination, offering a practical solution for clinicians managing hypertension in high-risk CHD patients.

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Cite This Research Paper
ZHANG Wei, LI Ming, WANG Fang, et al. (2025). Efficacy and Safety of Combined Antihypertensive Therapy in Patients with Coronary Heart Disease: A Randomized Controlled Trial. Chinese Journal of New Drugs. https://doi.org/pub_80__articleID_236
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Frequently Asked Questions

What is the incremental blood pressure reduction achieved by adding perindopril to amlodipine compared to amlodipine monotherapy?

The combination therapy reduced SBP by an additional 5.3 mmHg (23.5 vs 18.2 mmHg) and DBP by an additional 2.6 mmHg (12.4 vs 9.8 mmHg) over 24 weeks, with statistical significance (p<0.01 for SBP, p<0.05 for DBP).

How does the combination therapy affect the achievement of guideline-recommended blood pressure targets?

The combination group achieved target BP (<140/90 mmHg) in 82.5% of patients, significantly higher than the 65.0% in the monotherapy group (p<0.01), indicating a clinically meaningful improvement in BP control.

Are there any safety concerns regarding renal function or electrolyte balance with the combination therapy?

No significant changes in renal function (serum creatinine, eGFR), electrolytes (potassium, sodium), or liver enzymes were observed in either group, and adverse event rates were comparable (12.5% vs 10.8%, p>0.05), with no serious adverse events reported.

What is the tolerability profile of the combination therapy in terms of adverse events?

The combination therapy was well-tolerated, with adverse events occurring in 12.5% of patients, similar to monotherapy (10.8%). The most common adverse events were mild peripheral edema and cough, but no treatment discontinuations due to adverse events were recorded.

How does this combination therapy compare to other antihypertensive combinations in terms of efficacy and safety?

This study demonstrates that amlodipine-perindopril combination provides superior BP reduction and target achievement compared to amlodipine monotherapy, with a safety profile comparable to monotherapy. These findings align with previous meta-analyses showing that combination therapy is more effective than monotherapy, and the specific agent combination offers a favorable metabolic profile, making it suitable for CHD patients.

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