| Efficacy Evaluation of Atorvastatin in Korean Hyperlipidemic Patients with Type 2 Diabetes Mellitus. |
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Dong Seop Choi, Duk Kyu Kim, Doo Man Kim, Seong Yeon Kim, Moon Suk Nam, Yong Soo Park, Ho Sang Shon, Chul Woo Ahn, Kwan Woo Lee, Ki Up Lee, Moon Kyu Lee, Choon Hee Chung, Bong Yeon Cha |
1Department of Endocrinology & Metabolism College of Medicine Korea University, Korea.
2Department of Endocrinology Dong-A University Medical Center, Korea.
3Department of Endocrinology Kangdong Sacred Heart Hospital, Korea.
4Division of Endocrinology and Metabolism Seoul National University Hospital, Korea.
5Department of Endocrinology Inha University Hospital, Korea.
6Department of Endocrinology Hanyang University Guri Hospital, Korea.
7Department of Endocrinology Daegu Catholic University of Daegu, School of Medicine, Korea.
8Department of Endocrinology Yongdong Severance Hospital, Korea.
9Department of Endocrinology and Metabolism Ajou University Hospital, Korea.
10Department of Endocrinology Asan Medical Center, Korea.
11Department of Endocrinology and Metabolism Samsung Medical Center, Korea.
12Department of Endocrinology Yonsei University Wonju Christian Hospital, Korea.
13Department of Endocrinology & Metabolism College of Medicine the Catholic University of Korea. |
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| 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. |
| Key Words:
Atorvastatin, Hyperlipidemia, LDL-cholesterol, Total cholesterol, Type 2 diabetes mellitus |
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