title: Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe).
abstract: OBJECTIVE
  We aimed to compare the effects of fixed-dose combinations of ezetimibe plus rosuvastatin to rosuvastatin alone in patients with primary hypercholesterolemia, including a subgroup analysis of patients with diabetes mellitus (DM) or metabolic syndrome (MetS).
  
  
  METHODS
  This multicenter eight-week randomized double-blind phase III study evaluated the safety and efficacy of fixed-dose combinations of ezetimibe 10 mg plus rosuvastatin, compared with rosuvastatin alone in patients with primary hypercholesterolemia. Four hundred and seven patients with primary hypercholesterolemia who required lipid-lowering treatment according to the ATP III guideline were randomized to one of the following six treatments for 8 weeks: fixed-dose combinations with ezetimibe 10 mg daily plus rosuvastatin (5, 10, or 20 mg daily) or rosuvastatin alone (5, 10, or 20 mg daily).
  
  
  RESULTS
  Fixed-dose combination of ezetimibe plus rosuvastatin significantly reduced LDL cholesterol, total cholesterol, and triglyceride levels compared with rosuvastatin alone. Depending on the rosuvastatin dose, these fixed-dose combinations of ezetimibe plus rosuvastatin provided LDL cholesterol, total cholesterol, and triglyceride reductions of 56%-63%, 37%-43%, and 19%-24%, respectively. Moreover, the effect of combination treatment on cholesterol levels was more pronounced in patients with DM or MetS than in non-DM or non-MetS patients, respectively, whereas the effect of rosuvastatin alone did not differ between DM vs non-DM or MetS vs non-MetS patients.
  
  
  CONCLUSIONS
  Fixed-dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS.
authors: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Kyung-Jin
authors: KJ
authors: Kim
authors: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors: Sang-Hyun
authors: SH
authors: Kim
authors: Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Young Won
authors: YW
authors: Yoon
authors: Department of Internal Medicine, Medical College, Korea University, Seoul, Korea.
authors: Seung-Woon
authors: SW
authors: Rha
authors: Division of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
authors: Soon-Jun
authors: SJ
authors: Hong
authors: Division of Cardiology, Department of Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Korea.
authors: Choong-Hwan
authors: CH
authors: Kwak
authors: Cardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.
authors: Weon
authors: W
authors: Kim
authors: Division of Cardiology, Department of Internal Medicine, Dongsan Hospital, Keimyung University, Gyeongju, Korea.
authors: Chang-Wook
authors: CW
authors: Nam
authors: Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Korea.
authors: Moo-Yong
authors: MY
authors: Rhee
authors: Department of Internal Medicine, Cardiology Division, Dong-A University Hospital, Busan, Korea.
authors: Tae-Ho
authors: TH
authors: Park
authors: Pusan National University Hospital, Busan, Korea.
authors: Taek-Jong
authors: TJ
authors: Hong
authors: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Sungha
authors: S
authors: Park
authors: Department of Cardiology, Heart Center, Chonnam National University Hospital, Gwangju, Korea.
authors: Youngkeun
authors: Y
authors: Ahn
authors: Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
authors: Namho
authors: N
authors: Lee
authors: Department of Cardiovascular, Uijeongbu, Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors: Hui-Kyung
authors: HK
authors: Jeon
authors: Division of Cardiology, Department of Internal Medicine, NHIC Ilsan Hospital, Goyang, Korea.
authors: Dong-Woon
authors: DW
authors: Jeon
authors: Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea.
authors: Kyoo-Rok
authors: KR
authors: Han
authors: Cardiology Division, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.
authors: Keon-Woong
authors: KW
authors: Moon
authors: Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea. ihchae@snu.ac.kr.
authors: In-Ho
authors: IH
authors: Chae
authors: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea. hyosoo@snu.ac.kr.
authors: Hyo-Soo
authors: HS
authors: Kim
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D000069438:Ezetimibe / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008875:Middle Aged; D056910:Republic of Korea; D000068718:Rosuvastatin Calcium / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D000924:Anticholesteremic Agents; D015415:Biomarkers; D008078:Cholesterol, LDL; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014280:Triglycerides; D000068718:Rosuvastatin Calcium; D000069438:Ezetimibe
keywords: Cholesterol; Diabetes mellitus; Ezetimibe; Hypercholesterolemia; Metabolic syndrome; Rosuvastatin