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

Kyung Jin Kim, Sang Hyun Kim, Young Won Yoon, Seung Woon Rha, Soon Jun Hong, Choong Hwan Kwak, Weon Kim, Chang Wook Nam, Moo Yong Rhee, Tae Ho Park, Taek Jong Hong, Sungha Park, Youngkeun Ahn, Namho Lee, Hui Kyung Jeon, Dong Woon Jeon, Kyoo Rok Han, Keon Woong Moon, In Ho Chae, Hyo soo Kim

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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.

Original languageEnglish
Pages (from-to)371-382
Number of pages12
JournalCardiovascular Therapeutics
Volume34
Issue number5
DOIs
Publication statusPublished - 2016 Oct 1

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All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

Cite this

Kim, K. J., Kim, S. H., Yoon, Y. W., Rha, S. W., Hong, S. J., Kwak, C. H., Kim, W., Nam, C. W., Rhee, M. Y., Park, T. H., Hong, T. J., Park, S., Ahn, Y., Lee, N., Jeon, H. K., Jeon, D. W., Han, K. R., Moon, K. W., Chae, I. H., & Kim, H. S. (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. https://doi.org/10.1111/1755-5922.12213