Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia

Sang Hak Lee, Kyoung Im Cho, Jang Young Kim, Young Keun Ahn, Seung Woon Rha, Yong Jin Kim, Yun Seok Choi, Si Wan Choi, Dong Woon Jeon, Pil Ki Min, Dong Ju Choi, Sang Hong Baek, Kwon Sam Kim, Young Sup Byun, Yangsoo Jang

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia. Methods: A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10. mg plus fenofibrate 160. mg or rosuvastatin 10. mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation. Results: The rates of the primary outcome variables were similar between the two groups (2.8% and 3.9% in the combination and the rosuvastatin groups, respectively, p= 1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3% and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol. Conclusion: In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).

Original languageEnglish
Pages (from-to)169-175
Number of pages7
JournalAtherosclerosis
Volume221
Issue number1
DOIs
Publication statusPublished - 2012 Mar 1

Fingerprint

Fenofibrate
Hyperlipidemias
Therapeutics
Pharmaceutical Preparations
Rosuvastatin Calcium
Blood Urea Nitrogen
Incidence
Homocysteine
Alanine Transaminase
Leukocyte Count
HDL Cholesterol
Life Style
Creatinine
Hemoglobins
Pathology
Diet
Kidney
Muscles
Liver

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Sang Hak ; Cho, Kyoung Im ; Kim, Jang Young ; Ahn, Young Keun ; Rha, Seung Woon ; Kim, Yong Jin ; Choi, Yun Seok ; Choi, Si Wan ; Jeon, Dong Woon ; Min, Pil Ki ; Choi, Dong Ju ; Baek, Sang Hong ; Kim, Kwon Sam ; Byun, Young Sup ; Jang, Yangsoo. / Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. In: Atherosclerosis. 2012 ; Vol. 221, No. 1. pp. 169-175.
@article{b8dc00b8f4ad4fd8b108ce5ae221124d,
title = "Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia",
abstract = "Objective: The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia. Methods: A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10. mg plus fenofibrate 160. mg or rosuvastatin 10. mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation. Results: The rates of the primary outcome variables were similar between the two groups (2.8{\%} and 3.9{\%} in the combination and the rosuvastatin groups, respectively, p= 1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3{\%} and 5.6{\%}, respectively) and drug discontinuation due to AEs (10.0{\%} and 3.3{\%}, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol. Conclusion: In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).",
author = "Lee, {Sang Hak} and Cho, {Kyoung Im} and Kim, {Jang Young} and Ahn, {Young Keun} and Rha, {Seung Woon} and Kim, {Yong Jin} and Choi, {Yun Seok} and Choi, {Si Wan} and Jeon, {Dong Woon} and Min, {Pil Ki} and Choi, {Dong Ju} and Baek, {Sang Hong} and Kim, {Kwon Sam} and Byun, {Young Sup} and Yangsoo Jang",
year = "2012",
month = "3",
day = "1",
doi = "10.1016/j.atherosclerosis.2011.12.042",
language = "English",
volume = "221",
pages = "169--175",
journal = "Atherosclerosis",
issn = "0021-9150",
publisher = "Elsevier Ireland Ltd",
number = "1",

}

Lee, SH, Cho, KI, Kim, JY, Ahn, YK, Rha, SW, Kim, YJ, Choi, YS, Choi, SW, Jeon, DW, Min, PK, Choi, DJ, Baek, SH, Kim, KS, Byun, YS & Jang, Y 2012, 'Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia', Atherosclerosis, vol. 221, no. 1, pp. 169-175. https://doi.org/10.1016/j.atherosclerosis.2011.12.042

Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. / Lee, Sang Hak; Cho, Kyoung Im; Kim, Jang Young; Ahn, Young Keun; Rha, Seung Woon; Kim, Yong Jin; Choi, Yun Seok; Choi, Si Wan; Jeon, Dong Woon; Min, Pil Ki; Choi, Dong Ju; Baek, Sang Hong; Kim, Kwon Sam; Byun, Young Sup; Jang, Yangsoo.

In: Atherosclerosis, Vol. 221, No. 1, 01.03.2012, p. 169-175.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia

AU - Lee, Sang Hak

AU - Cho, Kyoung Im

AU - Kim, Jang Young

AU - Ahn, Young Keun

AU - Rha, Seung Woon

AU - Kim, Yong Jin

AU - Choi, Yun Seok

AU - Choi, Si Wan

AU - Jeon, Dong Woon

AU - Min, Pil Ki

AU - Choi, Dong Ju

AU - Baek, Sang Hong

AU - Kim, Kwon Sam

AU - Byun, Young Sup

AU - Jang, Yangsoo

PY - 2012/3/1

Y1 - 2012/3/1

N2 - Objective: The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia. Methods: A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10. mg plus fenofibrate 160. mg or rosuvastatin 10. mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation. Results: The rates of the primary outcome variables were similar between the two groups (2.8% and 3.9% in the combination and the rosuvastatin groups, respectively, p= 1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3% and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol. Conclusion: In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).

AB - Objective: The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia. Methods: A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10. mg plus fenofibrate 160. mg or rosuvastatin 10. mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation. Results: The rates of the primary outcome variables were similar between the two groups (2.8% and 3.9% in the combination and the rosuvastatin groups, respectively, p= 1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3% and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol. Conclusion: In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).

UR - http://www.scopus.com/inward/record.url?scp=84862806187&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84862806187&partnerID=8YFLogxK

U2 - 10.1016/j.atherosclerosis.2011.12.042

DO - 10.1016/j.atherosclerosis.2011.12.042

M3 - Article

C2 - 22269152

AN - SCOPUS:84862806187

VL - 221

SP - 169

EP - 175

JO - Atherosclerosis

JF - Atherosclerosis

SN - 0021-9150

IS - 1

ER -