title: Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia.
abstract: 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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Cardiology Division, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang-Hak
authors.initials: SH
authors.lastname: Lee
authors.forename: Kyoung-Im
authors.initials: KI
authors.lastname: Cho
authors.forename: Jang-Young
authors.initials: JY
authors.lastname: Kim
authors.forename: Young Keun
authors.initials: YK
authors.lastname: Ahn
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Yun-Seok
authors.initials: YS
authors.lastname: Choi
authors.forename: Si Wan
authors.initials: SW
authors.lastname: Choi
authors.forename: Dong Woon
authors.initials: DW
authors.lastname: Jeon
authors.forename: Pil-Ki
authors.initials: PK
authors.lastname: Min
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
authors.forename: Sang Hong
authors.initials: SH
authors.lastname: Baek
authors.forename: Kwon Sam
authors.initials: KS
authors.lastname: Kim
authors.forename: Young Sup
authors.initials: YS
authors.lastname: Byun
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
mesh_terms: D000368:Aged; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001806:Blood Urea Nitrogen; D002318:Cardiovascular Diseases / Q000097:blood / Q000208:ethnology / Q000209:etiology / Q000517:prevention & control*; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000209:etiology; D003404:Creatinine / Q000097:blood; D004338:Drug Combinations; D004798:Enzymes / Q000097:blood; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006710:Homocysteine / Q000097:blood; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000187:drug effects / Q000201:enzymology; D018579:Patient Selection; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D012206:Rhabdomyolysis / Q000097:blood / Q000139:chemically induced; D018570:Risk Assessment; D012307:Risk Factors; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D004338:Drug Combinations; D004798:Enzymes; D005464:Fluorobenzenes; D006454:Hemoglobins; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D008055:Lipids; D011743:Pyrimidines; D013449:Sulfonamides; D006710:Homocysteine; D000068718:Rosuvastatin Calcium; D003404:Creatinine; D011345:Fenofibrate