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

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)2571-2592
Number of pages22
JournalClinical Therapeutics
Volume41
Issue number12
DOIs
Publication statusPublished - 2019 Dec

Fingerprint

Lipids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Therapeutics
Apolipoproteins B
Ezetimibe
Rosuvastatin Calcium
Apolipoprotein A-I
Hypercholesterolemia
LDL Cholesterol

Keywords

  • Combination therapy
  • Ezetimibe
  • Hypercholesterolemia
  • Rosuvastatin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. / Rhee, Moo Yong; Kim, Kyung Jin; Kim, Sang Hyun; Yoon, Young Won; Rha, Seung Woon; Hong, Soon Jun; Kwak, Choong Hwan; Kim, Weon; Nam, Chang Wook; Park, Tae Ho; Hong, Taek Jong; Park, Sungha; Ahn, Youngkeun; Lee, Namho; Jeon, Hui Kyung; Jeon, Dong Woon; Han, Kyoo Rok; Moon, Keon Woong; Chae, In Ho; Kim, Hae Young; Kim, Hyo Soo.

In: Clinical Therapeutics, Vol. 41, No. 12, 12.2019, p. 2571-2592.

Research output: Contribution to journalArticle

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
Rhee, Moo Yong ; Kim, Kyung Jin ; Kim, Sang Hyun ; Yoon, Young Won ; Rha, Seung Woon ; Hong, Soon Jun ; Kwak, Choong Hwan ; Kim, Weon ; Nam, Chang Wook ; Park, Tae Ho ; Hong, Taek Jong ; Park, Sungha ; Ahn, Youngkeun ; Lee, Namho ; Jeon, Hui Kyung ; Jeon, Dong Woon ; Han, Kyoo Rok ; Moon, Keon Woong ; Chae, In Ho ; Kim, Hae Young ; Kim, Hyo Soo. / Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. In: Clinical Therapeutics. 2019 ; Vol. 41, No. 12. pp. 2571-2592.
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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.",
keywords = "Combination therapy, Ezetimibe, Hypercholesterolemia, Rosuvastatin",
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}",
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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

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.

KW - Combination therapy

KW - Ezetimibe

KW - Hypercholesterolemia

KW - Rosuvastatin

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