Physicians' Academy for Cardiovascular Education

Review of 8 trials on clinical benefit of ezetimibe on top of statins

Addition of ezetimibe to statins for patients at high cardiovascular risk: Systematic review of patient-important outcomes

Literature - Fei Y, Guyatt GH, Alexander PE, et al. - J Eval Clin Pract, 2017; published online ahead of print


Statins prevent vascular events, however many patients still suffer subsequent adverse vascular outcomes despite therapy [1]. Adjunctive lipid lowering therapies, such as ezetimibe, can further decrease cardiovascular (CV) risk. However, based on mixed results of randomised trials (RCTs) the 2013 AHA/ACC guidelines stated that there are insufficient data regarding the additional clinical benefit of ezetimibe add-on therapy [2].

Recently, the IMPROVE-IT study (2015), as well as a number of reviews, concluded that ezetimibe plus statin therapy was associated with an incremental reduction of LDL-C levels, and fewer composite CV outcomes [3-6].

To explore the robustness of the IMPROVE-IT study results in patient‐important outcomes such as mortality, CV events and adverse events, as well as to assess the consistency of various sized trials, this study systematically reviewed relevant RCTs and performed supplementary subgroup and sensitivity analyses.

Main results


Based on the IMPROVE-IT study, which comprised 93% of patients within the 8 eligible trials analysed, ezetimibe as add-on therapy to moderate‐dose statins is likely to result in 17 fewer MIs and possibly 6 fewer strokes/1000 treated over 6 years, but is unlikely to reduce all‐cause mortality or CV death. No specific increased harms were associated with the addition of ezetimibe to statins. Results of the 7 smaller trials were consistent with those of the IMPROVE-IT study. This systematic review contributes to the required evidence‐base for updating clinical practice guidelines in the face of the IMPROVE‐IT trial.


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