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July 4, 2018Current Medical Research and Opinion5 citations

Efficacy of zofenopril in combination with amlodipine in patients with acute myocardial infarction: a pooled individual patient data analysis of four randomized, double-blind, controlled, prospective studies

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CBClaudio BorghiSOStefano OmboniGRGiorgio Reggiardo

Key Result

In post-AMI patients, the combination of zofenopril and amlodipine significantly reduced the 1-year risk of cardiovascular events compared to other ACEIs plus amlodipine (HR 0.76; 95% CI 0.61-0.94).

Study Design

Type

Meta-Analysis (n=3,488)

Blinding

Double-blind

Randomization

Randomized

Structured PICO

Does zofenopril in combination with amlodipine reduce the 1-year combined occurrence of death or hospitalization for cardiovascular causes in post-AMI patients?

P
Population
3,488 post-acute myocardial infarction (AMI) patients from four pooled SMILE studies
I
Intervention
Zofenopril with concomitant amlodipine
C
Comparator
Placebo or other ACE inhibitors (with or without amlodipine)
O
Outcome
1-year combined occurrence of death or hospitalization for cardiovascular causescomposite

In post-AMI patients, the combination of zofenopril and amlodipine significantly reduces the 1-year risk of cardiovascular death or hospitalization compared to other ACE inhibitors or placebo.

Main Result

Effect estimate: HR 0.76 (95% CI 0.61-0.94)

p-value: p=0.013

Limitations

  • Post-hoc analysis

Abstract

OBJECTIVE: In the four SMILE (Survival of Myocardial Infarction Long-Term Evaluation) studies, early administration of zofenopril in acute myocardial infarction (AMI) showed beneficial effects as compared to placebo and other angiotensin converting enzyme inhibitors (ACEIs). This study investigated whether the concomitant administration of the dihydropyridine calcium channel-blocker amlodipine may improve zofenopril efficacy to prevent cardiovascular events in post-AMI patients. METHODS: This was a post-hoc analysis of pooled individual patient data from the four large randomized SMILE studies. The primary endpoint was the 1-year combined occurrence of death or hospitalization for cardiovascular causes. RESULTS: In total, 3488 patients were considered, 303 (8.7%) treated with concomitant amlodipine. Baseline systolic blood pressure and prevalence of metabolic syndrome were higher in amlodipine treated patients. The 1-year occurrence of major cardiovascular outcomes was significantly reduced in patients receiving concomitant treatment with amlodipine (hazard ratio, HR = 0.66; and 95% confidence interval, CI = 0.44-0.98; p = .039). After accounting for treatment with amlodipine, the risk of cardiovascular events was significantly reduced with zofenopril compared to placebo (HR = 0.78; 95% CI = 0.63-0.97; p = .026]. Among ACEI-treated patients, the zofenopril plus amlodipine combination reduced the risk of cardiovascular events by 38%, compared to the combination of other ACEIs plus amlodipine [HR = 0.76; 95% CI = 0.61-0.94); p = .013). The prognostic benefit of concomitant treatment with zofenopril plus amlodipine was independent from blood pressure lowering. CONCLUSIONS: Zofenopril had a positive impact on prognosis in post-AMI patients, compared to other ACEIs. Concomitant administration of amlodipine may help to reduce the risk of cardiovascular events at 1 year.

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Cite This Study

Borghi et al. (2018) conducted a meta-analysis in Acute myocardial infarction (n=3,488). Zofenopril in combination with amlodipine vs. Other ACEIs plus amlodipine was evaluated on 1-year combined occurrence of death or hospitalization for cardiovascular causes (HR 0.76, 95% CI 0.61-0.94, p=0.013). In post-AMI patients, the combination of zofenopril and amlodipine significantly reduced the 1-year risk of cardiovascular events compared to other ACEIs plus amlodipine (HR 0.76; 95% CI 0.61-0.94).

synapsesocial.com/papers/6a1c22d1ea84844e355f80b3https://doi.org/10.1080/03007995.2018.1496076
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