Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease

What this Trial Is About

Researchers are evaluating two cholesterol-lowering approaches to see which has a lower risk of causing new-onset diabetes in people with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). This multicenter, randomized study involves 2,000 non-diabetic participants and compares a combination of pitavastatin and ezetimibe with high-intensity statin therapy using rosuvastatin. The main goal is to measure new cases of diabetes over a 36-month follow-up, along with other cardiovascular outcomes and changes in blood markers. Participants will be randomly assigned to receive either a fixed-dose single-pill combination of pitavastatin 4 mg plus ezetimibe 10 mg or rosuvastatin 20 mg alone. The study lasts up to 3 years with ongoing treatment. Both treatment strategies aim to manage cholesterol levels while monitoring the risk of developing diabetes. The trial is organized by Korea University Anam Hospital and is conducted without masking, meaning both participants and researchers know the treatment given. Throughout the study, participants will undergo regular assessments including blood tests for fasting glucose, HbA1c, and insulin resistance, as well as monitoring for cardiovascular events like heart attacks and strokes. Researchers will track adherence to a cholesterol-lowering diet and collect safety data. The primary outcome is the occurrence of new diabetes cases meeting standard diagnostic criteria, while secondary outcomes include cardiovascular health and cholesterol changes. Participants' health will be followed for up to three years to evaluate these outcomes.

Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus