Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 fatty acids 4 g Fixed-Dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients Who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-Week, Multicenter, Randomized, Double-Blind Phase III Study
DC Field | Value | Language |
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dc.contributor.author | Woo, Jong Shin | - |
dc.contributor.author | Hong, Soon Jun | - |
dc.contributor.author | Cha, Dong Hoon | - |
dc.contributor.author | Kim, Kee Sik | - |
dc.contributor.author | Kim, Moo Hyun | - |
dc.contributor.author | Lee, Jun-Won | - |
dc.contributor.author | Jeong, Myung Ho | - |
dc.contributor.author | Jeong, Jin-Ok | - |
dc.contributor.author | Lee, Jun-Hee | - |
dc.contributor.author | Jeon, Doo Soo | - |
dc.contributor.author | Cho, Eun Joo | - |
dc.contributor.author | Kim, Soon Kil | - |
dc.contributor.author | Kwan, Jun | - |
dc.contributor.author | Park, Chang Gyu | - |
dc.contributor.author | Lee, Hae Young | - |
dc.contributor.author | Hong, Taek Jong | - |
dc.contributor.author | Shin, Jinho | - |
dc.contributor.author | Youn, Ho Joong | - |
dc.contributor.author | Jeon, Dong Woon | - |
dc.contributor.author | Chung, Wook Jin | - |
dc.contributor.author | Jeong, Ju Cheol | - |
dc.contributor.author | Kim, Chong Jin | - |
dc.date.accessioned | 2021-11-28T02:40:31Z | - |
dc.date.available | 2021-11-28T02:40:31Z | - |
dc.date.created | 2021-08-09 | - |
dc.date.issued | 2021-08 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/82774 | - |
dc.description.abstract | Purpose: Residual cardiovascular risk in patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with intensive statin treatment, is a global health issue. The purpose of this study was to investigate the efficacy and tolerability of treatment with a combination of high-dose atorvastatin/Ω-3 fatty acid compared to atorvastatin + placebo in patients with hypertriglyceridemia who did not respond to statin treatment. Methods: In this multicenter, randomized, double-blind, placebo-controlled study, patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment were randomly assigned to receive UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg + placebo (control). The primary efficacy end points were the percentage change from baseline in non–high density lipoprotein cholesterol (non–HDL-C) level at the end of treatment and the adverse events recorded during treatment. A secondary end point was the percentage change from baseline in triglyceride level. Findings: After 8 weeks of treatment, the percentage changes from baseline in non–HDL-C (–4.4% vs +0.6%; p = 0.02) and triglycerides (–18.5% vs +0.9%; p < 0.01) were significantly greater in the UI-018 group (n = 101) than in the control group (n = 99). These changes were present in subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m2), or without diabetes. The prevalences of adverse events did not differ between the 2 treatment groups. Implications: In patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose atorvastatin/Ω-3 fatty acid was associated with a greater reduction of triglyceride and non–HDL-C compared with atorvastatin + placebo, without significant adverse events. © 2021 The Author(s) | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER | - |
dc.relation.isPartOf | Clinical Therapeutics | - |
dc.title | Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 fatty acids 4 g Fixed-Dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients Who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-Week, Multicenter, Randomized, Double-Blind Phase III Study | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000714565400013 | - |
dc.identifier.doi | 10.1016/j.clinthera.2021.07.001 | - |
dc.identifier.bibliographicCitation | Clinical Therapeutics, v.43, no.8, pp.1419 - 1430 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85111504868 | - |
dc.citation.endPage | 1430 | - |
dc.citation.startPage | 1419 | - |
dc.citation.title | Clinical Therapeutics | - |
dc.citation.volume | 43 | - |
dc.citation.number | 8 | - |
dc.contributor.affiliatedAuthor | Chung, Wook Jin | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | atorvastatin | - |
dc.subject.keywordAuthor | combination treatment | - |
dc.subject.keywordAuthor | hypertriglyceridemia | - |
dc.subject.keywordAuthor | non–HDL-C | - |
dc.subject.keywordAuthor | Ω-3 fatty acid | - |
dc.subject.keywordPlus | EICOSAPENTAENOIC ACID | - |
dc.subject.keywordPlus | RISK-FACTORS | - |
dc.subject.keywordPlus | OMEGA-3-FATTY-ACIDS | - |
dc.subject.keywordPlus | TRIGLYCERIDES | - |
dc.subject.keywordPlus | LIPOPROTEINS | - |
dc.subject.keywordPlus | PREVENTION | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | INSULIN | - |
dc.subject.keywordPlus | STATIN | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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