Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Study Details
Study Description
Brief Summary
The purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group P Pitavastatin 4mg group |
Drug: Pitavastatin
Pitavastatin 4 mg will be given.
|
| Experimental: Group PE Pitavastatin 4 mg Ezetimibe 10 mg combined administration group |
Drug: Pitavastatin plus Ezetemibe
Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
|
| Active Comparator: Group A Atorvastatin 40 mg administration group |
Drug: Atorvastatin
Atorvastatin 40 mg will be given.
|
Outcome Measures
Primary Outcome Measures
- Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks [At 24 weeks]
Changes of homeostatic model assessment for insulin resistance (HOMA-IR) form baseline to 24 weeks will be compared among the three groups.
Secondary Outcome Measures
- Proportion of fasting glucose ≥100 mg/dL [At 24 weeks]
- Proportion of HbA1C ≥6.5% [At 24 weeks]
- Proportion of new-onset diabetes mellitus [At 24 weeks]
- Changes of HOMA-β at 24 weeks [At 24 weeks]
- Changes of fasting glucose at 24 weeks [At 24 weeks]
- Changes of insulin at 24 weeks [At 24 weeks]
- Changes of HbA1c at 24 weeks [At 24 weeks]
- Changes of triglyceride at 24 weeks [At 24 weeks]
- LDL-cholesterol change at 24 weeks [At 24 weeks]
- HDL-cholesterol change at 24 weeks [At 24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with dyslipidemia
-
Patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion)
-
Patients with metabolic syndrome but without diabetes
Exclusion Criteria:
-
Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year
-
Acute liver disease or persistent unexplained serum AST or ALT twice the upper limit of normal
-
Allergy or hypersensitivity to statins or ezetimibe
-
Solid organ transplant recipients
-
History of side effects requiring discontinuation of statin administration
-
Pregnant women, potentially pregnant or lactating women
-
Life expectancy less than 3 years
-
If it is judged that follow-up for more than 1 year is not possible
-
If the patient is unable to understand or read the consent form
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei University Health System, Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Principal Investigator: Byeong-Keuk Kim, Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2022-1325