Combination pitavastatin-ezetimibe therapy for hypercholesterolemia and mixed dyslipidemia: a systematic review and meta-analysis.

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.