Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy

Moo Yong Rhee; Kyung Jin Kim; Sang Hyun Kim; Young Won Yoon; Seung Woon Rha; Soon Jun Hong; Choong Hwan Kwak; Weon Kim; Chang Wook Nam; 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; Hae Young Kim; Hyo Soo Kim

doi:10.1016/j.clinthera.2019.10.010

Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy

Moo Yong Rhee, Kyung Jin Kim, Sang Hyun Kim, Young Won Yoon, Seung Woon Rha, Soon Jun Hong, Choong Hwan Kwak, Weon Kim, Chang Wook Nam, 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, Hae Young KimHyo Soo Kim

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

Purpose: The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy. Methods: This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups. Findings: Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non–HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074). Implications: Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.

Original language	English
Pages (from-to)	2571-2592
Number of pages	22
Journal	Clinical Therapeutics
Volume	41
Issue number	12
DOIs	https://doi.org/10.1016/j.clinthera.2019.10.010
Publication status	Published - 2019 Dec

Bibliographical note

Funding Information:
The primary study was initiated and financially supported by the Ministry of Health and Welfare through the Korea Health Industry Development Institute , Korea Health Technology R&D Project ( HI14C1277 ), and Hanmi Pharmaceutical Company . Dr. Rhee was responsible for conceptualization, formal analysis, methodology, investigation, and writing of the original draft; Drs. K.-J. Kim, S.-H. Kim, and Chae were responsible for conceptualization, methodology, investigation, and validation; Drs. Yoon, Rha, S.J. Hong, Kwak, W. Kim, Nam, T.-H. Park, T.-J. Hong, S. Park, Ahn, Lee, H.-K. Jeon, D.W. Jeon, Han, and K.-W. Moon were responsible for investigation and validation; Dr. H.-Y. Kim was responsible for the formal analysis; and Dr. H.-S. Kim was responsible for conceptualization, methodology, investigation, and writing of the original draft. All the authors approved the final version of the manuscript, including the authorship list.

Publisher Copyright:
© 2019

All Science Journal Classification (ASJC) codes

Pharmacology
Pharmacology (medical)

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10.1016/j.clinthera.2019.10.010

Cite this

Rhee, M. Y., Kim, K. J., Kim, S. H., Yoon, Y. W., Rha, S. W., Hong, S. J., Kwak, C. H., Kim, W., Nam, C. W., 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. (2019). Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clinical Therapeutics, 41(12), 2571-2592. https://doi.org/10.1016/j.clinthera.2019.10.010

@article{1f975bdf81ef4c1dad6865b4718ef380,

title = "Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy",

abstract = "Purpose: The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy. Methods: This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups. Findings: Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non–HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074). Implications: Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.",

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

note = "Funding Information: The primary study was initiated and financially supported by the Ministry of Health and Welfare through the Korea Health Industry Development Institute , Korea Health Technology R&D Project ( HI14C1277 ), and Hanmi Pharmaceutical Company . Dr. Rhee was responsible for conceptualization, formal analysis, methodology, investigation, and writing of the original draft; Drs. K.-J. Kim, S.-H. Kim, and Chae were responsible for conceptualization, methodology, investigation, and validation; Drs. Yoon, Rha, S.J. Hong, Kwak, W. Kim, Nam, T.-H. Park, T.-J. Hong, S. Park, Ahn, Lee, H.-K. Jeon, D.W. Jeon, Han, and K.-W. Moon were responsible for investigation and validation; Dr. H.-Y. Kim was responsible for the formal analysis; and Dr. H.-S. Kim was responsible for conceptualization, methodology, investigation, and writing of the original draft. All the authors approved the final version of the manuscript, including the authorship list. Publisher Copyright: {\textcopyright} 2019",

year = "2019",

month = dec,

doi = "10.1016/j.clinthera.2019.10.010",

language = "English",

volume = "41",

pages = "2571--2592",

journal = "Clinical Therapeutics",

issn = "0149-2918",

publisher = "Excerpta Medica",

number = "12",

}

Rhee, MY, Kim, KJ, Kim, SH, Yoon, YW, Rha, SW, Hong, SJ, Kwak, CH, Kim, W, Nam, CW, Park, TH, Hong, TJ, Park, S, Ahn, Y, Lee, N, Jeon, HK, Jeon, DW, Han, KR, Moon, KW, Chae, IH, Kim, HY & Kim, HS 2019, 'Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy', Clinical Therapeutics, vol. 41, no. 12, pp. 2571-2592. https://doi.org/10.1016/j.clinthera.2019.10.010

TY - JOUR

T1 - Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy

AU - Rhee, Moo Yong

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 - 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, Hae Young

AU - Kim, Hyo Soo

N1 - Funding Information: The primary study was initiated and financially supported by the Ministry of Health and Welfare through the Korea Health Industry Development Institute , Korea Health Technology R&D Project ( HI14C1277 ), and Hanmi Pharmaceutical Company . Dr. Rhee was responsible for conceptualization, formal analysis, methodology, investigation, and writing of the original draft; Drs. K.-J. Kim, S.-H. Kim, and Chae were responsible for conceptualization, methodology, investigation, and validation; Drs. Yoon, Rha, S.J. Hong, Kwak, W. Kim, Nam, T.-H. Park, T.-J. Hong, S. Park, Ahn, Lee, H.-K. Jeon, D.W. Jeon, Han, and K.-W. Moon were responsible for investigation and validation; Dr. H.-Y. Kim was responsible for the formal analysis; and Dr. H.-S. Kim was responsible for conceptualization, methodology, investigation, and writing of the original draft. All the authors approved the final version of the manuscript, including the authorship list. Publisher Copyright: © 2019

PY - 2019/12

Y1 - 2019/12

N2 - Purpose: The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy. Methods: This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups. Findings: Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non–HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074). Implications: Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.

AB - Purpose: The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy. Methods: This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups. Findings: Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non–HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074). Implications: Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.

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Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy

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