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Cardiovasc Ther. 2016;34(5):371-82.

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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제1저자 김경진, 김상현 · 교신저자 김효수, 채인호

PMID 27506635 PMC5108468 DOI 10.1111/1755-5922.12213 IF 2.8 순환기내과
소속 (20)
  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.

© 2016 The Authors Cardiovascular Therapeutics Published by John Wiley & Sons Ltd.

Keywords

CholesterolDiabetes mellitusEzetimibeHypercholesterolemiaMetabolic syndromeRosuvastatin

Figures

Figure 1
Figure 1 Participant distribution. FAS, full analysis set; E10, ezetimibe 10 mg; R5, rosuvastatin 5 mg; R10, rosuvastatin 10 mg; R20, rosuvastatin 20 mg
Figure 2
Figure 2 LDL cholesterol levels at baseline and after treatment. Bars represent standard errors; LDL, low‐density lipoprotein; E, ezetimibe 10 mg; R5, rosuvastatin 5 mg; R10, rosuvastatin 10 mg; R20, rosuvastatin 20 mg
Figure 3
Figure 3 Comparison of the percent changes in LDL cholesterol, TG, and HDL cholesterol between monotherapy and combo therapy for 8 wk: pooled data and data of the three different doses. Bars represent standard errors; LDL, low‐density lipoprotein; TG, triglyceride; HDL, high‐density lipoprotein; LS means, least‐squares means; R, rosuvastatin (pooled); E, ezetimibe 10 mg; R5, rosuvastatin 5 mg; R10, rosuvastatin 10 mg; R20, rosuvastatin 20 mg. *P<.05 for the specified between‐treatment difference
Figure 4
Figure 4 Greater reduction in cholesterol observed in patients with DM than in non‐DM patients receiving combo therapy. Among patients receiving combo therapy, patients with DM exhibited greater reductions in cholesterol compared to non‐DM patients, whereas patients with DM and non‐DM patients receiving monotherapy showed comparable levels of cholesterol reduction. Bars represent standard errors; DM, diabetes mellitus; LDL‐C, low‐density lipoprotein cholesterol; non‐HDL‐C, non‐high‐density lipoprotein cholesterol; Apo B, apolipoprotein B; TC, total cholesterol; R, rosuvastatin; E, ezetimibe. *P<.05 for the specified between‐treatment difference
Figure 5
Figure 5 Greater reduction in cholesterol in patients with MetS vs non‐MetS patients receiving combo therapy. Among patients receiving combo therapy, patients with MetS showed greater reductions in cholesterol compared to non‐MetS patients, whereas comparable reductions in cholesterol were observed in patients with MetS vs non‐MetS patients receiving monotherapy. Bars represent standard errors; MetS, metabolic syndrome; LDL‐C, low‐density lipoprotein cholesterol; non‐HDL‐C, non‐high‐density lipoprotein cholesterol; Apo B, apolipoprotein B; TC, total cholesterol; R, rosuvastatin; E, ezetimibe. *P<.05 for the specified between‐treatment difference

그림 출처: PubMed Central 공개 논문 (PMC5108468)

그 밖의 정보
출판 형태
Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
저널
Cardiovascular therapeutics · eISSN 1755-5922
MeSH
Aged · Anticholesteremic Agents / adverse effects / therapeutic use · Biomarkers / blood · Cholesterol, LDL / blood · Diabetes Mellitus / blood / diagnosis / drug therapy · Double-Blind Method · Drug Combinations · Ezetimibe / adverse effects / therapeutic use · Female · Humans · Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects / therapeutic use · Hypercholesterolemia / blood / diagnosis / drug therapy · Male · Metabolic Syndrome / blood / diagnosis / drug therapy · Middle Aged · Republic of Korea · Rosuvastatin Calcium / adverse effects / therapeutic use · Time Factors · Treatment Outcome · Triglycerides / blood
Substances
Anticholesteremic Agents · Biomarkers · Cholesterol, LDL · Drug Combinations · Hydroxymethylglutaryl-CoA Reductase Inhibitors · Triglycerides · Rosuvastatin Calcium · Ezetimibe
참고문헌
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