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Modeling of the LDL cholesterol-lowering effect of atorvastatin in Korean dyslipidemic patients and non-patient volunteers.

 Eun Sil Oh  ;  Sang-Hak Lee  ;  Min Soo Park  ;  Kyungsoo Park  ;  Jae-Yong Chung 
 International Journal of Clinical Pharmacology and Therapeutics, Vol.50(9) : 647-656, 2012 
Journal Title
 International Journal of Clinical Pharmacology and Therapeutics 
Issue Date
Adult ; Asian Continental Ancestry Group* ; Atorvastatin Calcium ; Biomarkers/blood ; Cholesterol, LDL/blood* ; Computer Simulation ; Decision Support Techniques ; Down-Regulation ; Drug Administration Schedule ; Drug Dosage Calculations ; Dyslipidemias/blood ; Dyslipidemias/drug therapy* ; Dyslipidemias/ethnology ; Female ; Heptanoic Acids/administration & dosage ; Heptanoic Acids/blood ; Heptanoic Acids/pharmacokinetics* ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/blood ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacokinetics* ; Male ; Middle Aged ; Models, Biological* ; Pyrroles/administration & dosage ; Pyrroles/blood ; Pyrroles/pharmacokinetics* ; Republic of Korea/epidemiology ; Treatment Outcome ; Young Adult
modeling ; LDL-lowering ; pharmacodynamics ; atorvastatin ; NONMEM
OBJECTIVE: The aim of this study was to develop a longitudinal pharmacodynamic model describing the time-courses of low-density lipoprotein cholesterol (LDL) profiles during and after atorvastatin treatment in Korean dyslipidemic patients and non-patient volunteers. METHODS: 15 dyslipidemic patients and 11 non-patient volunteers with no prior therapy participated in a parallel, 2-step dose escalation study. Subjects received atorvastatin doses ranging from 10 to 80 mg for 42 days (dyslipidemic patients) or 10 mg for 21 days (non-patient volunteers). Plasma samples were collected before and during the treatment period and up to 2 weeks after the last administration. A population pharmacodynamic model was built using the NONMEM software package. An indirect response model consisting of production in hepatocyte and elimination from plasma stimulated by atorvastatin described the LDL time-course. RESULTS: The typical population value of the estimated dose producing 50% of maximal stimulation on LDL elimination (SD50) for dyslipidemic patients was 11.9 mg, which was about 6 times higher than that of non-patient volunteers (2.0 mg). CONCLUSION: A longitudinal population pharmacodynamic model for the LDL-lowering effect of atorvastatin in both dyslipidemic patients and non-patient volunteers was developed. This could help guide optimal therapies according to the target population.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Park, Kyungsoo(박경수) ORCID logo https://orcid.org/0000-0002-6972-1143
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Lee, Sang Hak(이상학) ORCID logo https://orcid.org/0000-0002-4535-3745
Chung, Jae Yong(정재용)
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