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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
DC Field | Value | Language |
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dc.contributor.author | 이병완 | - |
dc.date.accessioned | 2021-09-29T00:29:59Z | - |
dc.date.available | 2021-09-29T00:29:59Z | - |
dc.date.issued | 2020-10 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/183873 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Excerpta Medica | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Apolipoproteins B / blood | - |
dc.subject.MESH | Cholesterol / blood | - |
dc.subject.MESH | Cholesterol, LDL / blood | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Dyslipidemias / drug therapy* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Fenofibrate / administration & dosage* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use | - |
dc.subject.MESH | Lipids / blood | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Quinolines / administration & dosage* | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Triglycerides / blood | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Sang-Hyun Ihm | - |
dc.contributor.googleauthor | Woo-Baek Chung | - |
dc.contributor.googleauthor | Jong-Min Lee | - |
dc.contributor.googleauthor | Byung-Hee Hwang | - |
dc.contributor.googleauthor | Ki-Dong Yoo | - |
dc.contributor.googleauthor | Sung-Ho Her | - |
dc.contributor.googleauthor | Woo-Hyuk Song | - |
dc.contributor.googleauthor | In-Ho Chae | - |
dc.contributor.googleauthor | Tae-Ho Park | - |
dc.contributor.googleauthor | Ju-Han Kim | - |
dc.contributor.googleauthor | Dong Woon Jeon | - |
dc.contributor.googleauthor | Byung-Ryul Cho | - |
dc.contributor.googleauthor | Seung-Ho Kang | - |
dc.contributor.googleauthor | Sang-Don Park | - |
dc.contributor.googleauthor | Jin-Bae Lee | - |
dc.contributor.googleauthor | Jeong-Taek Woo | - |
dc.contributor.googleauthor | Byung-Wan Lee | - |
dc.contributor.googleauthor | Kyung-Ah Han | - |
dc.contributor.googleauthor | Kyung-Heon Won | - |
dc.contributor.googleauthor | Hyo-Soo Kim | - |
dc.contributor.googleauthor | Jae-Myung Yu | - |
dc.contributor.googleauthor | Choon Hee Chung | - |
dc.contributor.googleauthor | Hae-Jin Kim | - |
dc.contributor.googleauthor | Ho-Chan Cho | - |
dc.contributor.googleauthor | Ki-Bae Seung | - |
dc.identifier.doi | 10.1016/j.clinthera.2020.08.002 | - |
dc.contributor.localId | A02796 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 32891418 | - |
dc.subject.keyword | cardiovascular disease | - |
dc.subject.keyword | dyslipidemia | - |
dc.subject.keyword | fenofibrate | - |
dc.subject.keyword | non–high-density lipoprotein cholesterol | - |
dc.subject.keyword | pitavastatin | - |
dc.contributor.alternativeName | Lee, Byung Wan | - |
dc.contributor.affiliatedAuthor | 이병완 | - |
dc.citation.volume | 42 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 2021 | - |
dc.citation.endPage | 2035.e3 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.42(10) : 2021-2035.e3, 2020-10 | - |
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