Korean AMADEUS Study

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Eight Weeks Treatment, Single Step Titration, Open Label Study Assessing the Percentage of Korean Diabetic Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Dose 10mg, 20mg, 40mg

Conditions
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Diabetes Mellitus, Hypercholessterolemia

Intervention / Treatment
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* Drug: Atorvastatin, 10mg, 20mg, 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Korean Diabetes Patients Is ≥ 18 and ≤ 80 years olds Has diagnosis of dyslipidemia Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl Has triglyceride level ≤ 600 mg/dl Has HbA1c ≤ 12% If female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator Can discontinue all current antilipidemic medication for the 4 week washout period Has provided written informed consent prior to the initiation of any study procedure Exclusion Criteria: Is pregnant or lactating Abuse alcohol and/or any other drug Uncontrolled diabetes ( HbA1c > 12% ) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin, 10mg, 20mg, 40mg|If initial LDL cholesterol between 100  129mg/dl then starting dose of Atorvastatin is 10mg, 130 159 mg/dl is 20 mg, 160 220mg/dl is 40mg. After 4weeks treatment, if LDL cholesterol is below 100mg/dl then continue starting dose and if not reach below 100mg/dl then titration double dose. After 4 weeks treatment, recheck the LDL cholesterol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment. |  | 8 weeks | 
| 2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL cholesterol, HDL cholesterol, non-HDL cholesterol, LDL cholesterol/HDL cholesterol ratio, Total cholesterol, Triglyceride subjects in the total group. |  | 8 weeks | 
| 3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin |  | 8 weeks | 
| 4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP |  | 8 weeks | 
| 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Hypercholesterolemia