Background and Aims: Here, we compared the effects of combination therapy of low- or moderate-statin with ezetimibe and high-intensity statin monotherapy in patients with type 2 diabetes without previous cardiovascular disease (CVD) on incident CVD and all cause mortalities in a real-world setting.

Methods: Using the Korean National Health Insurance Service datasets, two cohorts comparing high intensity statin monotherapy with low- or moderate-intensity statin and ezetimibe combination therapy were constructed using a 1:1 propensity score matching procedure and were followed up for 3.4 years. The primary outcome was a composite of myocardial infarction (MI), stroke, and all-cause mortality. The secondary outcome was the occurrence of individual events.

Results: Compared to high-intensity statin monotherapy, moderate-intensity statin with ezetimibe combination therapy significantly reduced the risk of composite outcomes (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.74 - 0.98, P=0.029) as well as stroke (HR 0.70, 95% CI 0.52 - 0.93, P=0.014), but not MI or all cause mortalities. However, there was no significant risk reduction in composite outcomes following low-intensity statin therapy with ezetimibe (HR 1.02, 95% CI 0.75 - 1.39, P=0.882) than that after high-intensity statin monotherapy. The statin with ezetimibe combination showed a consistent efficacy regardless of diverse patients’ baseline characteristics. Conclusions: Moderate-intensity statin with ezetimibe combination therapy was superior to high-intensity statin monotherapy for CVD primary prevention, and low-intensity statin with ezetimibe showed a comparable efficacy to high-intensity statin monotherapy in patients with type 2 diabetes.


Y.Hwang: None. S.Park: None. I.Jeong: None. K.Ahn: None. H.Chung: None.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at