Effect of Ezetimibe on Gut Microbiota
Gut Microbiota Alteration With Atorvastatin/Ezetimibe Combination in Patients With Atherosclerotic Cardiovascular Disease
Yonsei University
110 participants
Feb 28, 2024
INTERVENTIONAL
Conditions
Summary
Ezetimibe exerts its primary effects by inhibiting intestinal cholesterol absorption through the NPC1L1 protein. Beyond this, its impact on gut microbiota remains an area of interest. Gut microbiota has been implicated in cholesterol metabolism and CVD pathogenesis through metabolic and non-metabolic pathways. Modulating gut microbiota has been explored as a potential strategy to prevent CVDs. Despite its intestinal mechanism, the influence of ezetimibe on gut microbiota composition has not been thoroughly investigated. Future studies are needed to elucidate its potential interactions with gut microbial communities and their implications for cholesterol metabolism and cardiovascular health.
Eligibility
Inclusion Criteria6
- Age: 19 to 80 years old
- Criteria for Diagnosis of Coronary Artery Disease:
- Patients diagnosed with coronary artery disease through coronary angiography, or
- Patients who require high-intensity lipid-lowering therapy according to current guidelines:
- Clinical atherosclerotic cardiovascular disease, LDL cholesterol ≥ 190 mg/dL, LDL 70-189 mg/dL in diabetic patients, 10-year calculated atherosclerotic cardiovascular disease risk ≥ 7.5%
- \- Voluntary Consent: Individuals who have voluntarily agreed to participate in the study and signed the consent form.
Exclusion Criteria11
- Patients with active liver disease or liver disease with AST/ALT levels elevated more than twice the upper limit of normal.
- Individuals with allergies or hypersensitivity to HMG-CoA reductase inhibitors or ezetimibe.
- Individuals with a history of adverse reactions to HMG-CoA reductase inhibitors or ezetimibe.
- Pregnant, breastfeeding, or women of childbearing potential.
- Organ transplant recipients or individuals scheduled for organ transplantation.
- Patients with active malignant tumors.
- Patients with inflammatory bowel disease.
- Patients with wasting diseases, autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), or connective tissue diseases (e.g., systemic sclerosis, polymyositis, and dermatomyositis).
- Patients with a history of taking antibiotics, probiotics, or ezetimibe within 3 months prior to study screening.
- Patients who have undergone gastrointestinal surgery within the past year.
- Patients who do not understand the study content or are unable to provide consent.
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Interventions
High intensity HMG-CoA reductase inhibitor
Moderate intensity HMG-CoA reductase inhibitor plus NPC1L1 antagonist
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06784557