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Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia.

 Sang-Hak Lee  ;  Kyoung-Im Cho  ;  Jang-Young Kim  ;  Young Keun Ahn  ;  Seung-Woon Rha  ;  Yong-Jin Kim  ;  Yun-Seok Choi  ;  Si Wan Choi  ;  Dong Woon Jeon  ;  Pil-Ki Min  ;  Dong-Ju Choi  ;  Sang Hong Baek  ;  Kwon Sam Kim  ;  Young Sup Byun  ;  Yangsoo Jang 
 ATHEROSCLEROSIS, Vol.221(1) : 169-175, 2012 
Journal Title
Issue Date
Aged ; Asian Continental Ancestry Group* ; Biomarkers/blood ; Blood Glucose/metabolism ; Blood Urea Nitrogen ; Cardiovascular Diseases/blood ; Cardiovascular Diseases/ethnology ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control* ; Chemical and Drug Induced Liver Injury/blood ; Chemical and Drug Induced Liver Injury/etiology ; Creatinine/blood ; Drug Combinations ; Enzymes/blood ; Female ; Fenofibrate/adverse effects ; Fenofibrate/therapeutic use* ; Fluorobenzenes/adverse effects ; Fluorobenzenes/therapeutic use* ; Hemoglobins/metabolism ; Homocysteine/blood ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Hyperlipidemias/blood ; Hyperlipidemias/complications ; Hyperlipidemias/drug therapy* ; Hyperlipidemias/ethnology ; Hypolipidemic Agents/adverse effects ; Hypolipidemic Agents/therapeutic use* ; Lipids/blood ; Liver/drug effects ; Liver/enzymology ; Male ; Middle Aged ; Muscle, Skeletal/drug effects ; Muscle, Skeletal/enzymology ; Patient Selection ; Pyrimidines/adverse effects ; Pyrimidines/therapeutic use* ; Republic of Korea/epidemiology ; Rhabdomyolysis/blood ; Rhabdomyolysis/chemically induced ; Risk Assessment ; Risk Factors ; Rosuvastatin Calcium ; Sulfonamides/adverse effects ; Sulfonamides/therapeutic use* ; Time Factors ; Treatment Outcome
Asia ; Creatine kinase ; Fenofibrate ; Rosuvastatin ; Safety
OBJECTIVE: The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia. METHODS: A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10 mg plus fenofibrate 160 mg or rosuvastatin 10 mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation. RESULTS: The rates of the primary outcome variables were similar between the two groups (2.8% and 3.9% in the combination and the rosuvastatin groups, respectively, p=1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3% and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol. CONCLUSION: In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Min, Pil Ki(민필기) ORCID logo https://orcid.org/0000-0001-7033-7651
Lee, Sang Hak(이상학) ORCID logo https://orcid.org/0000-0002-4535-3745
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
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