Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk

Young June Yang, Sang Hak Lee, Byung Soo Kim, Yun Kyeong Cho, Hyun Jai Cho, Kyoung Im Cho, Seok Yeon Kim, Jae Kean Ryu, Jin Man Cho, Joong Il Park, Jong Seon Park, Chang Gyu Park, Woo Jung Chun, Myung A. Kim, Dong Kyu Jin, Namho Lee, Byung Jin Kim, Kwang Kon Koh, Jon Suh, Seunghwan LeeByoung Kwon Lee, Seung Jin Oh, Han Young Jin, Youngkeun Ahn, Sang Gon Lee, Jang Ho Bae, Woo Jung Park, Sang Chol Lee, Han Cheol Lee, Jaewon Lee, Cheolwon Park, Backhwan Lee, Yangsoo Jang

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Abstract

Purpose The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. Methods This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. Findings The percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. Implications Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

Original languageEnglish
Pages (from-to)107-117
Number of pages11
JournalClinical Therapeutics
Volume39
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Therapeutics
Group Psychotherapy
Cholesterol
Ezetimibe
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Multicenter Studies
Triglycerides
Placebos
Guidelines
Lipids
Education
Pharmaceutical Preparations
oxidized low density lipoprotein
low density lipoprotein inhibitor

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Yang, Young June ; Lee, Sang Hak ; Kim, Byung Soo ; Cho, Yun Kyeong ; Cho, Hyun Jai ; Cho, Kyoung Im ; Kim, Seok Yeon ; Ryu, Jae Kean ; Cho, Jin Man ; Park, Joong Il ; Park, Jong Seon ; Park, Chang Gyu ; Chun, Woo Jung ; Kim, Myung A. ; Jin, Dong Kyu ; Lee, Namho ; Kim, Byung Jin ; Koh, Kwang Kon ; Suh, Jon ; Lee, Seunghwan ; Lee, Byoung Kwon ; Oh, Seung Jin ; Jin, Han Young ; Ahn, Youngkeun ; Lee, Sang Gon ; Bae, Jang Ho ; Park, Woo Jung ; Lee, Sang Chol ; Lee, Han Cheol ; Lee, Jaewon ; Park, Cheolwon ; Lee, Backhwan ; Jang, Yangsoo. / Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk. In: Clinical Therapeutics. 2017 ; Vol. 39, No. 1. pp. 107-117.
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abstract = "Purpose The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. Methods This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. Findings The percentage change of LDL-C ranged from –45{\%} to –56{\%} (mean, –51{\%}) in the monotherapy groups and from –58{\%} to –63{\%} (mean, –60{\%}) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64{\%} to 87{\%} (mean, 73{\%}) in the monotherapy groups and 87{\%} to 95{\%} (mean, 91{\%}) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. Implications Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.",
author = "Yang, {Young June} and Lee, {Sang Hak} and Kim, {Byung Soo} and Cho, {Yun Kyeong} and Cho, {Hyun Jai} and Cho, {Kyoung Im} and Kim, {Seok Yeon} and Ryu, {Jae Kean} and Cho, {Jin Man} and Park, {Joong Il} and Park, {Jong Seon} and Park, {Chang Gyu} and Chun, {Woo Jung} and Kim, {Myung A.} and Jin, {Dong Kyu} and Namho Lee and Kim, {Byung Jin} and Koh, {Kwang Kon} and Jon Suh and Seunghwan Lee and Lee, {Byoung Kwon} and Oh, {Seung Jin} and Jin, {Han Young} and Youngkeun Ahn and Lee, {Sang Gon} and Bae, {Jang Ho} and Park, {Woo Jung} and Lee, {Sang Chol} and Lee, {Han Cheol} and Jaewon Lee and Cheolwon Park and Backhwan Lee and Yangsoo Jang",
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Yang, YJ, Lee, SH, Kim, BS, Cho, YK, Cho, HJ, Cho, KI, Kim, SY, Ryu, JK, Cho, JM, Park, JI, Park, JS, Park, CG, Chun, WJ, Kim, MA, Jin, DK, Lee, N, Kim, BJ, Koh, KK, Suh, J, Lee, S, Lee, BK, Oh, SJ, Jin, HY, Ahn, Y, Lee, SG, Bae, JH, Park, WJ, Lee, SC, Lee, HC, Lee, J, Park, C, Lee, B & Jang, Y 2017, 'Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk', Clinical Therapeutics, vol. 39, no. 1, pp. 107-117. https://doi.org/10.1016/j.clinthera.2016.11.014

Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk. / Yang, Young June; Lee, Sang Hak; Kim, Byung Soo; Cho, Yun Kyeong; Cho, Hyun Jai; Cho, Kyoung Im; Kim, Seok Yeon; Ryu, Jae Kean; Cho, Jin Man; Park, Joong Il; Park, Jong Seon; Park, Chang Gyu; Chun, Woo Jung; Kim, Myung A.; Jin, Dong Kyu; Lee, Namho; Kim, Byung Jin; Koh, Kwang Kon; Suh, Jon; Lee, Seunghwan; Lee, Byoung Kwon; Oh, Seung Jin; Jin, Han Young; Ahn, Youngkeun; Lee, Sang Gon; Bae, Jang Ho; Park, Woo Jung; Lee, Sang Chol; Lee, Han Cheol; Lee, Jaewon; Park, Cheolwon; Lee, Backhwan; Jang, Yangsoo.

In: Clinical Therapeutics, Vol. 39, No. 1, 01.01.2017, p. 107-117.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk

AU - Yang, Young June

AU - Lee, Sang Hak

AU - Kim, Byung Soo

AU - Cho, Yun Kyeong

AU - Cho, Hyun Jai

AU - Cho, Kyoung Im

AU - Kim, Seok Yeon

AU - Ryu, Jae Kean

AU - Cho, Jin Man

AU - Park, Joong Il

AU - Park, Jong Seon

AU - Park, Chang Gyu

AU - Chun, Woo Jung

AU - Kim, Myung A.

AU - Jin, Dong Kyu

AU - Lee, Namho

AU - Kim, Byung Jin

AU - Koh, Kwang Kon

AU - Suh, Jon

AU - Lee, Seunghwan

AU - Lee, Byoung Kwon

AU - Oh, Seung Jin

AU - Jin, Han Young

AU - Ahn, Youngkeun

AU - Lee, Sang Gon

AU - Bae, Jang Ho

AU - Park, Woo Jung

AU - Lee, Sang Chol

AU - Lee, Han Cheol

AU - Lee, Jaewon

AU - Park, Cheolwon

AU - Lee, Backhwan

AU - Jang, Yangsoo

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Purpose The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. Methods This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. Findings The percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. Implications Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

AB - Purpose The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. Methods This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. Findings The percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. Implications Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

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