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.

Disclosure

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

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