Efficacy and Safety of Ezetimibe and Rosuvastatin Combination Therapy Versus Those of Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

被引：22

作者：

Kim, Woohyeun ^{[1
]}

Yoon, Yeonyee E. ^{[2
]}

Shin, Sung-Hee ^{[3
]}

Bae, Jang-Whan ^{[4
]}

Hong, Bum-Kee ^{[5
]}

Hong, Soon Jun ^{[6
]}

Sung, Ki Chul ^{[7
]}

Han, Seung Hwan ^{[8
]}

Kim, Weon ^{[9
]}

Rhee, Moo-Yong ^{[10
]}

Kim, Sang-Hyun ^{[11
]}

Lee, Sang Eun ^{[12
]}

Hyon, Min Su ^{[13
]}

Hwang, Gyo-Seung ^{[14
]}

Son, Jang Won ^{[15
]}

Kim, Jang-Young ^{[16
]}

Kim, Min Kyu ^{[17
]}

Kim, Sang Wook ^{[18
]}

Park, Jae-Hyeong ^{[19
]}

Shin, Jin Ho ^{[20
]}

Park, Chang Gyu ^{[1
]}

机构：

[1] Korea Univ, Cardiovasc Ctr, Dept Cardiol, Guro Hosp, Seoul, South Korea

[2] Seoul Natl Univ, Cardiovasc Ctr, Dept Cardiol, Bundang Hosp, Seongnam, South Korea

[3] Inha Univ, Dept Internal Med, Div Cardiol, Coll Med, Incheon, South Korea

[4] Chungbuk Natl Univ, Dept Internal Med, Div Cardiol, Coll Med, Cheongju, South Korea

[5] Yonsei Univ, Gangnam Severance Hosp, Heart Ctr, Div Cardiol,Coll Med, Seoul, South Korea

[6] Korea Univ, Cardiovasc Ctr, Dept Cardiol, Anam Hosp, Seoul, South Korea

[7] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Dept Internal Med, Div Cardiol,Sch Med, Seoul, South Korea

[8] Gachon Univ, Div Cardiol, Gil Med Ctr, Incheon, South Korea

[9] Kyung Hee Univ, Kyung Hee Univ Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea

[10] Donstuk Univ, Cardiovasc Ctr, Ilsan Hosp, Goyang, South Korea

[11] Seoul Natl Univ, Dept Internal Med, Div Cardiol, Seoul Metropolitan Govt,Boramae Med Ctr, Seoul, South Korea

[12] Asan Med Ctr, Div Cardiol, Seoul, South Korea

[13] Soonchunhyang Univ, Dept Internal Med, Div Cardiol, Seoul Hosp, Seoul, South Korea

[14] Ajou Univ, Dept Cardiol, Sch Med, Suwon, South Korea

[15] Yeungnam Univ Hosp, Dept Internal Med, Div Cardiol, Daegu, South Korea

[16] Yonsei Univ, Dept Cardiol, Wonju Coll Med, Wonju, South Korea

[17] Hallym Univ, Dept Internal Med, Div Cardiol, Dontan Sacred Heart Hosp, Hwaseong, South Korea

[18] Chung Ang Univ Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea

[19] Chungnam Natl Univ, Chungnam Natl Univ Hosp, Dept Internal Med, Div Cardiol,Coll Med, Daejeon, South Korea

[20] Hanyang Univ Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea

来源：

CLINICAL THERAPEUTICS | 2018年 / 40卷 / 06期

关键词：

cardiovascular diseases; combination therapy; ezetimibe; LDL-C; rosuvastatin; CORONARY-HEART-DISEASE; CHOLESTEROL ABSORPTION INHIBITOR; STATIN THERAPY; MYOCARDIAL-INFARCTION; SERUM-CHOLESTEROL; RISK; ATORVASTATIN; METAANALYSIS; SIMVASTATIN; LIPOPROTEINS;

D O I：

10.1016/j.clinthera.2018.04.015

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Purpose: The aim of this study was to evaluate the safety and efficacy of combination treatment of rosuvastatin with ezetimibe in patients with primary hypercholesterolemia. Methods: This multicenter, randomized, double-blind study comprised a main study and an extension study. In the main study, the efficacy and safety of a combination of rosuvastatin (5, 10, and 20 mg) with ezetimibe (10 mg) were compared with those of rosuvastatin (5, 10, and 20 mg) alone. The subjects who achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the main study and agreed to a further study were enrolled for the extension study. In the extension study, ezetimibe 10 mg was also administered to subjects who had received rosuvastatin (5, 10, and 20 mg) alone in the main study, and the same treatment was continued for subjects who had received a combination of rosuvastatin with ezetimibe in the main study. Findings: At the end of the main study (week 8), LDL-C levels were significantly lower in subjects receiving combination therapy than in those receiving rosuvastatin monotherapy. Other lipid profiles also significantly improved in the combination therapy group. These improvements continued in the extension study. The combination therapy of rosuvastatin and ezetimibe was generally well tolerated. At the end of the main study, more subjects achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C goal in the combination therapy group than in the monotherapy group. The increased dosage of rosuvastatin was also well tolerated in the combination treatment. (C) 2018 Published by Elsevier HS Journals, Inc.

引用

页码：993 / 1013

页数：21

共 43 条

[1] Intensive statin therapy in acute coronary syndromes and stable coronary heart disease: a comparative meta-analysis of randomised controlled trials [J].