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Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial

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Author(s)
Sang-Hyun IhmWoo-Baek ChungJong-Min LeeByung-Hee HwangKi-Dong YooSung-Ho HerWoo-Hyuk SongIn-Ho ChaeTae-Ho ParkJu-Han KimDong Woon JeonByung-Ryul ChoSeung-Ho KangSang-Don ParkJin-Bae LeeJeong-Taek WooByung-Wan LeeKyung-Ah HanKyung-Heon WonHyo-Soo KimJae-Myung YuChoon Hee ChungHae-Jin KimHo-Chan ChoKi-Bae Seung
Keimyung Author(s)
Cho, Ho Chan
Department
Dept. of Internal Medicine (내과학)
Journal Title
Clinical therapeutics
Issued Date
2020
Volume
42
Issue
10
Keyword
cardiovascular diseasedyslipidemiafenofibratenonehigh-density lipoprotein cholesterolpitavastatin
Abstract
Purpose:
Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD.

Methods:
This multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150–500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non–HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment.

Findings:
The difference in the mean percentage change in non–HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was −12.45% (95% CI, −17.18 to −7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non–HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% ( P = 0.0110) and 78.94% versus 68.45% ( P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy.

Implications:
In these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non–HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797 .
Keimyung Author(s)(Kor)
조호찬
Publisher
School of Medicine (의과대학)
Citation
Sang-Hyun Ihm et al. (2020). Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial. Clinical therapeutics, 42(10), 2021–2035. doi: 10.1016/j.clinthera.2020.08.002
Type
Article
ISSN
1879-114X
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0149291820303532
DOI
10.1016/j.clinthera.2020.08.002
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43042
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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