KMID : 0648320080140020031
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Journal of The Korean Society of Hypertension 2008 Volume.14 No. 2 p.31 ~ p.36
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Achieving Low Density Lipoprotein Cholesterol Goals and Safety by Atorvastatin Therapy in High-risk Korean Patients
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Sohn Il-Suk
Bae Jong-Hoa Kim Soo-Joong Cho Jin-Man Kim Woo-Shik Kim Myeong-Kon Kim Chong-Jin Kim Kwon-Sam Lipitor Study Investigators
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Abstract
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Background : It has been proved that elevated low density lipoprotein cholesterol (LDL-C) is major cause of coronary heart disease (CHD) and intensive LDL-C lowering therapy reduces risk for CHD. But the use of lipid lowering agents is sometimes inadequate. And for the most patients therapeutic goals were not achieved. In this study, the optimal dose and duration to achieve target goal (LDL-C lower than 100 mg/dL) based on the NCEP ATP III guidelines was evaluated in hyperlipidemic patients with CHD or CHD risk equivalents. Efficacy, safety and the incidence of adverse event after administration of atorvastatin under the usual care were evaluated.
Methods : A total 1,090 case record forms were collected from 44 institutions. A total of 1,080 subjects were evaluated for safety assessment, 994 subjects for intention-to-treat (ITT) analysis, and 831 subjects for per protocol (PP) analysis.
Results : The mean duration of atorvastatin treatment was 27.5¡¾9.1 weeks. Daily dose of atorvastatin at the last visit was 10 mg/day in 78.5%.The subjects whose LDL-C level was on target goal (LDL-C < 100mg/dL after the administration of atorvastatin) were 62.9 % in ITT and 63.3% in PP. The percent change in LDL-C(-40.01¡¾14.89, p<0.001), total cholesterol (-29.20¡¾12.82, p<0.001) and triglyceride (-8.26¡¾43.24) after administration of atorvastatin in PP group were significant, but not for the HDL cholesterol (1.11¡¾18.99, p=ns). Regarding the safety, 14 adverse reactions were reported in 13 subjects (1.2%) and 10 adverse drug reactions in 9 subjects (0.83%).
Conclusion : A total 62.9% was on the target goal (LDL-C < 100mg/dL) in ITT group, and 63.3% in PP group. Overall adverse event rate were 1.2%. Therefore atorvastatin have good efficacy and safety profile for high-risk Korean patients.
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KEYWORD
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LDL cholesterol, Hyperlipidemia, Statins
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