title: Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk.
abstract: The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk.
  
  
  
  This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed.
  
  
  
  The percentage change of LDL-C ranged from -45% to -56% (mean, -51%) in the monotherapy groups and from -58% to -63% (mean, -60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups.
  
  
  
  Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Young-June
authors.initials: YJ
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea. Electronic address: shl1106@yuhs.ac.
authors.forename: Sang-Hak
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Daedong Hospital, Busan, Korea.
authors.forename: Byung Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Keimyung University Dongsan Medical Center, Daegu, Korea.
authors.forename: Yun-Kyeong
authors.initials: YK
authors.lastname: Cho
authors.affiliation: Cardiovascular Center and Cardiovascular Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Hyun-Jai
authors.initials: HJ
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Cardiovascular Research Institute, Kosin University School of Medicine, Busan, Korea.
authors.forename: Kyoung Im
authors.initials: KI
authors.lastname: Cho
authors.affiliation: Department of Cardiology, Seoul Medical Center, Seoul, Korea.
authors.forename: Seok-Yeon
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Daegu Catholic University Medical Center, Daegu, Korea.
authors.forename: Jae Kean
authors.initials: JK
authors.lastname: Ryu
authors.affiliation: Department of Cardiology, Kyunghee University East-West Neo Medical Center, Seoul, Korea.
authors.forename: Jin-Man
authors.initials: JM
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.
authors.forename: Joong-Il
authors.initials: JI
authors.lastname: Park
authors.affiliation: Department of Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Jong-Seon
authors.initials: JS
authors.lastname: Park
authors.affiliation: Department of Cardiology, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Chang Gyu
authors.initials: CG
authors.lastname: Park
authors.affiliation: Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Chun
authors.affiliation: Division of Cardiology, Department of Internal Medicine, SMG-SNU Seoul Boramae Hospital, Seoul, Korea.
authors.forename: Myung-A
authors.initials: MA
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Dong-Kyu
authors.initials: DK
authors.lastname: Jin
authors.affiliation: Cardiology Division, Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea.
authors.forename: Namho
authors.initials: N
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Byung Jin
authors.initials: BJ
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Kwang Kon
authors.initials: KK
authors.lastname: Koh
authors.affiliation: Department of Cardiology, Soonchunhyang University Hospital Bucheon, Bucheon, Korea.
authors.forename: Jon
authors.initials: J
authors.lastname: Suh
authors.affiliation: Division of Cardiology, Wonju College of Medicine, Yonsei University, Wonju, Korea.
authors.forename: Seung-Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Byoung-Kwon
authors.initials: BK
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, NHIS Ilsan Hospital, Goyang, Korea.
authors.forename: Seung-Jin
authors.initials: SJ
authors.lastname: Oh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
authors.forename: Han-Young
authors.initials: HY
authors.lastname: Jin
authors.affiliation: Department of Cardiology, Heart Research Center of Chonnam National University, Gwangju, Korea.
authors.forename: Youngkeun
authors.initials: Y
authors.lastname: Ahn
authors.affiliation: Department of Cardiology, Ulsan University College of Medicine, Ulsan, Korea.
authors.forename: Sang-Gon
authors.initials: SG
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea.
authors.forename: Jang-Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Hallym University Medical Center, Anyang, Korea.
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Sang-Chol
authors.initials: SC
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Han Cheol
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Research & Development Division, Alvogen Korea Co., Ltd., Seoul, Korea.
authors.forename: Jaewon
authors.initials: J
authors.lastname: Lee
authors.affiliation: Research & Development Division, Alvogen Korea Co., Ltd., Seoul, Korea.
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Park
authors.affiliation: Research & Development Division, Alvogen Korea Co., Ltd., Seoul, Korea.
authors.forename: Backhwan
authors.initials: B
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea. Electronic address: jangys1212@yuhs.ac.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000209:etiology; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014280:Triglycerides; D000068718:Rosuvastatin Calcium; D002784:Cholesterol; D000069438:Ezetimibe
keywords: LDL; cardiovascular diseases; cholesterol; drug combinations; ezetimibe; rosuvastatin calcium