Korean AMADEUS Study

The Catholic University of Korea

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Hypercholessterolemia

Treatments: Drug: Atorvastatin, 10mg, 20mg, 40mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01239849

SKimlipid

Details and patient eligibility

About

Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. & NCEP ATP III update. However, there are large unmet medical needs for DM patients who don't reach their target LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest dose of statin and then titrate to the goal. Thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for DM patients. Besides that, we are going to find out preliminary data about other markers change; small dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain the impact of triglyceride. Adiponectin is another good marker related with obesity and metabolic syndrome.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Korean Diabetes Patients
2. Is ≥ 18 and ≤ 80 years olds
3. Has diagnosis of dyslipidemia
4. Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl
5. Has triglyceride level ≤ 600 mg/dl
6. Has HbA1c ≤ 12%
7. If female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator
8. Can discontinue all current antilipidemic medication for the 4 week washout period
9. Has provided written informed consent prior to the initiation of any study procedure

Exclusion criteria

1. Is pregnant or lactating
2. Abuse alcohol and/or any other drug
3. Uncontrolled diabetes ( HbA1c > 12% )
4. Has impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT,SGOT) or aspartate aminotransferase (AST, SGOT) ≥ 2times the upper limit of normal at baseline.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)