![]() ![]() Thus, there is a gap of evidence in the medical literature to support this statement. ![]() The 2018 AHA/ACC Cholesterol Guideline stated that “The addition of ezetimibe or bile acid sequestrants to statin therapy typically provides an additional 15% to 25% reduction in LDL-C”, but, oddly, no reference regarding this statement was provided in the guideline. Several small trials on this topic have been conducted, but results are conflicting. The possibility that the co-administration of high-intensity statin may offset the limited benefits of ezetimibe, making the addition of ezetimibe unnecessary cannot be ruled out.Īs outcome trial evaluating the combination of high-intensity statin and ezetimibe was not available, the LDL-C levels as a surrogate endpoint could be used alternatively to evaluate the benefits of ezetimibe when adding to the high-intensity statin therapy. Whether the modest benefit observed in the IMPROVE-IT trial can be extrapolated into the real-world patients taking ezetimibe with a high-intensity statin is unknown. The only available outcome study that was cited in the guidelines was the IMPROVE-IT trial, in which a moderate-intensive statin was used and ezetimibe only demonstrated a modest reduction in cardiovascular events. Unfortunately, there have been no large-scale randomized double-blinded clinical trials to evaluate the combination of high-intensity statin therapy and ezetimibe. ![]() Moreover, 12.6% of patients with ACS in the study were on the combination therapy of a statin and ezetimibe, and among them, about 60% of patients took a high-intensity statin and ezetimibe. In real-world practice, the maximally tolerated statin therapy is a high-intensity statin for majority patients, as evidenced by a prospective cohort study showing that approximately 70% of patients took a high-intensity statin at 1 year after acute coronary syndromes (ACS). However, there is a lack of high-quality evidence for these moderate or weak recommendations, with no level A evidence provided in the 2018 AHA/ACC Cholesterol Guideline. Ezetimibe was also recommended in patients with severe hypercholesterolemia on maximally tolerated statin therapy and the LDL-C level ≥ 2.6 mmol/L (100 mg/dL). It was recommended by the 2018 AHA/ACC Guideline on the Management of Blood Cholesterol (2018 AHA/ACC Cholesterol Guideline) for patients with clinical ASCVD receiving maximally tolerated statin therapy when the low-density lipoprotein cholesterol (LDL-C) level remains ≥ 1.8 mmol/L (70 mg/dL). Keywords: Ezetimibe High-intensity statin LDL-C Hypercholesterolemia Coronary heart disease IntroductionĮzetimibe is the most used non-statin medication for secondary prevention in patients with clinical atherosclerotic cardiovascular disease (ASCVD). Whether the magnitude of this additional lowering of LDL-C levels would lead to benefits in clinical cardiovascular outcomes needs further investigation. No significant publication bias among the included trials was identified.Ĭonclusions: Our study found that adding ezetimibe to high-intensity statin therapy provided a significant but attenuated incremental reduction in LDL-C levels. Compared to the high-intensity statin monotherapy, the MD in LDL-C reduction with high-intensity statin therapy plus ezetimibe was -14.00% (95% confidence interval: -17.78 to -10.22 P < 0.001) with a moderate degree of heterogeneity (P < 0.001, I 2 = 66%). Results: A total of 14 trials with 2,007 patients were included in this study. The Cochrane Collaboration’s tool for assessing the risk of bias was used to evaluate the quality of the included trials. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this meta-analysis, in which the random-effects model was adopted for the calculation of the mean difference (MD). Methods: A literature search from database inception to May 2020 was performed using PubMed, EMBASE and Cochrane Central Register of Controlled Trials. A meta-analysis was performed to evaluate the efficacy of ezetimibe added to high-intensity statin therapy on LDL-C levels. Background: Adding ezetimibe to high-intensity statin therapy is used for additional lowering of low-density lipoprotein cholesterol (LDL-C) however, there are little data on the efficacy of ezetimibe when combined with a high-intensity statin. ![]()
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