A multi-center, open-label, observational study to evaluate the efficacy and safety of LivaloZet

Introduction: Dyslipidemia accompanied by metabolic syndrome substantially elevates cardiovascular risk by clustering multiple risk factors, including abdominal obesity, hypertension, hyperglycemia, and atherogenic dyslipidemia. The prevalence of both conditions is rising in Korea, underscoring the need for effective and metabolically safe lipid-lowering therapy. LivaloZet Methods and analysis: The PIVOT study is a multi-center, non-interventional, prospective observational study enrolling up to 10,000 Korean adult patients with dyslipidemia accompanied by metabolic syndrome who have been prescribed LivaloZet Discussion: The PIVOT study will generate prospective large-scale real-world evidence on the LDL-C-lowering effectiveness and safety patterns associated with use of a pitavastatin/ezetimibe fixed-dose combination in Korean patients with dyslipidemia accompanied by metabolic syndrome. The inclusion of glucose metabolism and inflammatory markers will provide descriptive information on the metabolic safety profile of this regimen. As a non-randomized, single-arm observational study, this design cannot establish causal effects or comparative efficacy versus other lipid-lowering regimens. Findings should be interpreted descriptively, acknowledging potential confounding by indication, selection bias, and inter-laboratory variability.