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

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Author(s)
Kyung‐Jin KimSang‐Hyun KimYoung Won YoonSeung‐Woon RhaSoon‐Jun HongChoong‐Hwan KwakWeon KimChang‐Wook NamMoo‐Yong RheeTae‐Ho ParkTaek‐Jong HongSungha ParkYoungkeun AhnNamho LeeHui‐Kyung JeonDong‐Woon JeonKyoo‐Rok HanKeon‐Woong MoonIn‐Ho ChaeHyo‐soo Kim
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Cardiovascular Therapeutics
Issued Date
2016
Volume
34
Issue
5
Keyword
CholesterolDiabetes mellitusEzetimibeMypercholesterolemiaMetabolic syndromeRosuvastatin
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. 
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine
Citation
Kyung‐Jin Kim et al. (2016). Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe). Cardiovascular Therapeutics, 34(5), 371–382. doi: doi.org/10.1111/1755-5922.12213
Type
Article
ISSN
1755-5914
DOI
doi.org/10.1111/1755-5922.12213
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32382
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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