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Background <p>It is well known that diabetes mellitus (DM) is an important risk factor for the development of cardiovascular diseases (CVD). Ezetimibe, an inhibitor of cholesterol absorption, is now a second-line lipid-lowering therapy with apparently more benefits. Ezetimibe can be used in addition to a statin in order to further reduce low density lipoprotein (LDL) levels. In this analysis, we aimed to systematically compare the cardiovascular outcomes and the adverse drug reactions associated with the use of ezetimibe in combination with a statin versus statin monotherapy in type 2 DM patients with higher risk for myocardial infarction (MI).</p> Methods <p>Web of science (WOS), MEDLINE, Clinicaltrials.gov, EMBASE, Google scholar and the Cochrane database were searched for studies comparing endpoints with ezetimibe-statin combination versus statin monotherapy in DM patients with higher cardiovascular risks. Major cardiovascular outcomes, stroke and adverse drug events were the endpoints in this study. The statistical analysis was carried out by the RevMan 5.4 software. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following statistical analysis.</p> Results <p>Twelve studies with a total number of 25,591 DM participants (12,478 assigned to ezetimibe-statin and 13,113 assigned to statin monotherapy) with higher risk for MI were included in this analysis. Results of this analysis showed that when the cardiovascular outcomes were compared, major adverse cardiovascular events (MACEs) were significantly lower in the ezetimibe-statin group with RR: 0.90, 95% CI: 0.82 – 0.99; <i>P</i> = 0.02. However, all cause mortality, cardiovascular death, MI, atrial fibrillation, hospitalization for unstable angina, and hospitalization for heart failure were similar. The adverse drug events were also compared without any significantly different result.</p> Conclusions <p>Our analysis showed that ezetimibe-statin combination was associated with a significantly lower risk of MACEs without increasing the risk of adverse drug reactions when compared to statin monotherapy in these DM patients with higher risk for MI. However, due to several limitations, and the influence of data from observational studies, this hypothesis must be cautiously considered until further larger trials are carried out to confirm the results.</p>

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Cardiovascular outcomes and adverse drug reactions associated with the use of ezetimibe in combination with a statin in diabetes mellitus patients with higher risk for myocardial infarction: a meta-analysis

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  • 发表日期：

    2026年1月19日

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  • Yan Zhou,
  • Ji Jin

摘要

Background

It is well known that diabetes mellitus (DM) is an important risk factor for the development of cardiovascular diseases (CVD). Ezetimibe, an inhibitor of cholesterol absorption, is now a second-line lipid-lowering therapy with apparently more benefits. Ezetimibe can be used in addition to a statin in order to further reduce low density lipoprotein (LDL) levels. In this analysis, we aimed to systematically compare the cardiovascular outcomes and the adverse drug reactions associated with the use of ezetimibe in combination with a statin versus statin monotherapy in type 2 DM patients with higher risk for myocardial infarction (MI).

Methods

Web of science (WOS), MEDLINE, Clinicaltrials.gov, EMBASE, Google scholar and the Cochrane database were searched for studies comparing endpoints with ezetimibe-statin combination versus statin monotherapy in DM patients with higher cardiovascular risks. Major cardiovascular outcomes, stroke and adverse drug events were the endpoints in this study. The statistical analysis was carried out by the RevMan 5.4 software. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following statistical analysis.

Results

Twelve studies with a total number of 25,591 DM participants (12,478 assigned to ezetimibe-statin and 13,113 assigned to statin monotherapy) with higher risk for MI were included in this analysis. Results of this analysis showed that when the cardiovascular outcomes were compared, major adverse cardiovascular events (MACEs) were significantly lower in the ezetimibe-statin group with RR: 0.90, 95% CI: 0.82 – 0.99; P = 0.02. However, all cause mortality, cardiovascular death, MI, atrial fibrillation, hospitalization for unstable angina, and hospitalization for heart failure were similar. The adverse drug events were also compared without any significantly different result.

Conclusions

Our analysis showed that ezetimibe-statin combination was associated with a significantly lower risk of MACEs without increasing the risk of adverse drug reactions when compared to statin monotherapy in these DM patients with higher risk for MI. However, due to several limitations, and the influence of data from observational studies, this hypothesis must be cautiously considered until further larger trials are carried out to confirm the results.