TY - JOUR
T1 - Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia
T2 - MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe)
AU - Kim, Kyung Jin
AU - Kim, Sang Hyun
AU - Yoon, Young Won
AU - Rha, Seung Woon
AU - Hong, Soon Jun
AU - Kwak, Choong Hwan
AU - Kim, Weon
AU - Nam, Chang Wook
AU - Rhee, Moo Yong
AU - Park, Tae Ho
AU - Hong, Taek Jong
AU - Park, Sungha
AU - Ahn, Youngkeun
AU - Lee, Namho
AU - Jeon, Hui Kyung
AU - Jeon, Dong Woon
AU - Han, Kyoo Rok
AU - Moon, Keon Woong
AU - Chae, In Ho
AU - Kim, Hyo soo
N1 - Funding Information:
The contributions of the MRS-ROZE study investigators and Hanmi Corporation are gratefully acknowledged.
Publisher Copyright:
© 2016 The Authors Cardiovascular Therapeutics Published by John Wiley & Sons Ltd
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
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U2 - 10.1111/1755-5922.12213
DO - 10.1111/1755-5922.12213
M3 - Article
C2 - 27506635
AN - SCOPUS:84991094126
SN - 1755-5914
VL - 34
SP - 371
EP - 382
JO - Cardiovascular Therapeutics
JF - Cardiovascular Therapeutics
IS - 5
ER -
