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BACKGROUND: Dyslipidemia is a prevalent and major contributor to atherosclerotic cardiovascular disease; however, many patients do not achieve the recommended low-density lipoprotein cholesterol goals with statin monotherapy. Thus, the efficacy of complementary therapeutic options must be investigated. OBJECTIVE: To evaluate the lipid-lowering efficacy and safety of pitavastatin combined with ezetimibe versus pitavastatin monotherapy in adults with hypercholesterolemia or mixed dyslipidemia. METHODS: A systematic search of PubMed, Embase, Cochrane Library, and Scopus (November 2025) identified randomized controlled trials that compared pitavastatin 2 mg or 4 mg plus ezetimibe 10 mg with pitavastatin 2 mg alone. The protocol for this systematic review and meta-analysis was prospectively registered in PROSPERO. A random-effects meta-analysis was used to pool lipid and safety outcomes. The risk of bias was assessed using RoB 2, and the certainty of evidence was graded using the GRADE tool. RESULTS: Non-high-density lipoprotein cholesterol, total cholesterol, and Apolipoprotein B. Changes in high-density lipoprotein cholesterol and triglyceride levels were modest but more pronounced at week 12. CONCLUSION: Combination therapy offers an apparent enhancement in lipid lowering and may serve as an effective supplementary option for patients who require more intensive low-density lipoprotein cholesterol management. However, the limited evidence warrants further research. PROTOCOL REGISTRATION: www.crd.york.ac.uk/prospero identifier is CRD420251233057.
Abbas et al. (Mon,) studied this question.