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Cardiovasc Ther. 2016 Oct;34(5):371-82. doi: 10.1111/1755-5922.12213.

Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe).

Author information

1
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
2
Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
3
Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
4
Department of Internal Medicine, Medical College, Korea University, Seoul, Korea.
5
Division of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
6
Division of Cardiology, Department of Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Korea.
7
Cardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.
8
Division of Cardiology, Department of Internal Medicine, Dongsan Hospital, Keimyung University, Gyeongju, Korea.
9
Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Korea.
10
Department of Internal Medicine, Cardiology Division, Dong-A University Hospital, Busan, Korea.
11
Pusan National University Hospital, Busan, Korea.
12
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
13
Department of Cardiology, Heart Center, Chonnam National University Hospital, Gwangju, Korea.
14
Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
15
Department of Cardiovascular, Uijeongbu, Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
16
Division of Cardiology, Department of Internal Medicine, NHIC Ilsan Hospital, Goyang, Korea.
17
Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea.
18
Cardiology Division, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.
19
Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea. ihchae@snu.ac.kr.
20
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea. hyosoo@snu.ac.kr.

Abstract

AIM:

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).

METHOD:

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.

CONCLUSION:

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.

KEYWORDS:

Cholesterol; Diabetes mellitus; Ezetimibe; Hypercholesterolemia; Metabolic syndrome; Rosuvastatin

PMID:
27506635
PMCID:
PMC5108468
DOI:
10.1111/1755-5922.12213
[Indexed for MEDLINE]
Free PMC Article

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