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
- Authors
- Ihm, Sang-Hyun; Chung, Woo-Baek; Lee, Jong-Min; Hwang, Byung-Hee; Yoo, Ki-Dong; Her, Sung-Ho; Song, Woo-Hyuk; Chae, In-Ho; Park, Tae-Ho; Kim, Ju-Han; Jeon, Dong Woon; Cho, Byung-Ryul; Kang, Seung-Ho; Park, Sang-Don; Lee, Jin-Bae; Woo, Jeong-Taek; Lee, Byung-Wan; Han, Kyung-Ah; Won, Kyung-Heon; Kim, Hyo-Soo; Yu, Jae-Myung; Chung, Choon Hee; Kim, Hae-Jin; Cho, Ho-Chan; Seung, Ki-Bae
- Issue Date
- Oct-2020
- Publisher
- Excerpta Medica, Inc.
- Keywords
- cardiovascular disease; dyslipidemia; fenofibrate; non-high-density lipoprotein cholesterol; pitavastatin
- Citation
- Clinical Therapeutics, v.42, no.10, pp 2021 - U87
- Indexed
- SCIE
SCOPUS
- Journal Title
- Clinical Therapeutics
- Volume
- 42
- Number
- 10
- Start Page
- 2021
- End Page
- U87
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/51888
- DOI
- 10.1016/j.clinthera.2020.08.002
- ISSN
- 0149-2918
1879-114X
- 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.
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Collections - 2. Clinical Science > Department of Cardiology > 1. Journal Articles
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