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
Clinical therapeutics
2020Sep ; 262 ( 36 ) :.
PMID : 32891418
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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 -
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. CI - Copyright ??2020 The Authors. Published by Elsevier Inc. All rights reserved.
keyword
cardiovascular disease; dyslipidemia; fenofibrate; non?high-density lipoprotein cholesterol; pitavastatin
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