Journal List > J Korean Diabetes Assoc > v.30(4) > 1062390

Choi, Kim, Kim, Kim, Nam, Park, Shon, Ahn, Lee, Lee, Lee, Chung, Cha, and 83 investigators: Efficacy Evaluation of Atorvastatin in Korean Hyperlipidemic Patients with Type 2 Diabetes Mellitus

Abstract

Background

NCEP ATP III Guideline recommends aggressive treatments of diabetic dyslipidemia, recognizing diabetes mellitus as CHD risk equivalents. This study was conducted to evaluate the effectiveness and safety of atorvastatin in hyperlipidemic patients with Type 2 diabetes mellitus through post-marketing drug use investigation of atorvastatin.

Methods

An open, multi-center, non-comparison, titrated dosage study was conducted in hyperlipidemic patients, who were treated with atorvastatin at first visiting hospitals from Mar. 2004 to Sep. 2004. 96 endocrinologists participated from 66 centers in this study. Total 2,182 hyperlipidemic patients were enrolled and 1,514 patients among them were accompanied by diabetes mellitus. Efficacy was evaluated at later than 4-week treatment by % change of total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from baseline. Percent of patients reaching LDL-cholesterol level less than 100 mg/dL was also analyzed. The adverse events incidence and abnormalities of clinical laboratory values were evaluated for safety monitoring.

Results

Total cholesterol, triglycerides, and LDL-cholesterol level were reduced by 26.6%, 12.0%, and 34.8%, respectively, in diabetic hyperlipidemic patients after atorvastatin treatment. The patients with LDL-cholesterol level of less than 100 mg/dL were increased from 2.8% to 52.6%. Atorvastatin was considered to be safe because adverse drug reactions were reported in 32 patients (1.5%) of total 2,182 patients.

Conclusion

Atorvastatin was effective and safe in hyperlipidemic patients with type 2 diabetes mellitus.

Figures and Tables

Table 1
Baseline Characteristics of Enrolled Patients
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Table 2
Blood Pressure in Hyperlipidemic Patients with Diabetes Mellitus
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Table 3
Changes in Lipid Profile after Atorvastatin Treatment in Hyperlipidemic Patients
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Table 4
Changes in Lipid Profile after Atorvastatin Treatment in Hyperlipidemic Patients with Type 2 Diabetes Mellitus
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Table 5
Distribution of LDL-C Levels in Hyperlipidemic Patients with Diabetes Mellitus (%)
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Table 6
Changes in Glucose Level and HbA1C Level in Hyperlipidemic Patients with Diabetes Mellitus
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Table 7
Incidence of Adverse Drug Reactions by Body System in Total Hyperlipidemic Patients and DM-Complicated Hyperlipidemic Patients
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