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To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed.
This study included a total of 70 patients (35 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.
The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver segments between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin monotherapy | Active Comparator | Rosuvastatin 5mg 1T daily for 6 months |
|
| Rosuvastatin + ezetimibe combination therapy | Experimental | Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 5mg 1T daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments | MRI is used to measure the fat fraction in 9 liver segments, and this test has been reported to be more sensitive than the biopsy-based steatosis grade assessment in confirming liver fat changes in previous studies | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fibrosis measured by MRE(magnetic resonance elastography) | The secondary endpoint is to analyze the changes before and after drug administration for the following items: Liver fibrosis measured by magnetic resonance elastography | 6 months |
| Change in hepatic steatosis index - controlled attenuation parameter (CAP) |
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Inclusion Criteria:
D. The main risk factors are as follows:
i. smoking ii. Hypertension - systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg or antihypertensive iii. Low HDL cholesterol (<40 mg / dL) iv. Age - Male 45+, Female 55+ v. Family history of early onset coronary artery disease - Parents, siblings with a history of coronary artery disease in men under 55 and women under 65 vi. High HDL cholesterol (60 mg / dL) or more is regarded as a protective factor and one of the total risk factors is reduced
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25482832 | Background | Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27. | |
| 35307033 |
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This study will conduct to evaluate the efficacy of liver fat lowering and safety of rosuvastatin 5mg alone or in combination with rosuvastatin 5mg / ezetimibe 10mg for 6 months.
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Open label
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| Rosuvastatin/ezetimibe combination |
| Drug |
Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months |
|
The secondary endpoint is to analyze the changes before and after drug administration for the following items: controlled attenuation parameter (CAP) |
| 6 months |
| Change in hepatic fibrosis index - liver stiffness measurement (LSM) measured by transient liver elastography (Fibroscan®; Echosens, Paris, France) | The secondary endpoint is to analyze the changes before and after drug administration for the following items: liver stiffness measurement (LSM) measured by fibroscan | 6 months |
| Changes in body weight (kg) before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: body weight | 6 months |
| Changes in waist circumference (cm) before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: WC | 6 months |
| Changes in systolic & diastolic blood pressure (mmHg) before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: SBP, DBP | 6 months |
| Changes in serum concentrations of insulin (µU/mL), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: fasting insulin | 6 months |
| Changes in serum concentrations of fasting glucose (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: fasting glucose | 6 months |
| Changes in serum concentrations of HbA1c (percent), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: HbA1c | 6 months |
| Change in insulin sensitivity determined by homeostatic model assessment insulin resistance (HOMA-IR) and beta cell function determined by HOMA-beta | The secondary endpoint is to analyze the changes before and after drug administration for the following items: HOMAIR, HOMA-beta | 6 months |
| Changes in serum concentrations of free fatty acid (μEq/L), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: free fatty acid | 6 months |
| Changes in serum concentrations of platelet (×103/ μL), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: platelet | 6 months |
| Changes in serum concentrations of alkaline phosphate (U/L) and gamma-GT(U/L), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: Alk,phos, GGT | 6 months |
| Changes in serum concentrations of total bilirubin (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: total bilirubin | 6 months |
| Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: ALT, AST | 6 months |
| Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: LDL-C, TG, HDL, TC | 6 months |
| Changes in serum concentrations of CRP (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: High-sensitivity CRP | 6 months |
| Changes in the level of liver injury markers including IL-1beta, IL-8, IL-18 (pg/mL) before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: biomarker ( IL-1b, IL-8, IL18) | 6 months |
| Changes in plasminogen activator inhibitor-1 (ng/mL) in peripheral blood mononuclear cells, before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: tPAI-1 | 6 months |
| Changes in BMI (kg/m^2) before and after the administration of rosuvastatin with/without ezetimibe | The secondary endpoint is to analyze the changes before and after drug administration for the following items: BMI | 6 months |
| Derived |
| Cho Y, Rhee H, Kim YE, Lee M, Lee BW, Kang ES, Cha BS, Choi JY, Lee YH. Ezetimibe combination therapy with statin for non-alcoholic fatty liver disease: an open-label randomized controlled trial (ESSENTIAL study). BMC Med. 2022 Mar 21;20(1):93. doi: 10.1186/s12916-022-02288-2. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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