Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

Summary

This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.

Eligibility

Inclusion Criteria:

* Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
* Male or female of 20 years or over
* Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL

  * moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
* Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
* Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
* Creatinine ≤1.8 mg/dL

Exclusion Criteria:

* Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
* Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg
* Severe renal dysfunction: eGFR \<30 mL/min/1.73m2
* AST/ALT \>120/120 or chronic liver disease
* Pregnant or childbearing woman who does not have enough contraception
* Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
* Usage of dyslipidemia therapy other than statin

Conditions4

Browse More Trials