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A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
DC Field | Value | Language |
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dc.contributor.author | 김병극 | - |
dc.date.accessioned | 2023-04-07T01:17:04Z | - |
dc.date.available | 2023-04-07T01:17:04Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193860 | - |
dc.description.abstract | Purpose: Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia. Methods: Korean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4-8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. Findings: The percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (-52.8% [11.2%]) and pooled pitavastatin (-37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C-lowering effect than that with pitavastatin (difference, -15.8 mg/dL; 95% CI, -18.7 to -12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups. Implications: Pitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. Clinicaltrials: gov identifier: NCT04584736. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Excerpta Medica | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Anticholesteremic Agents* / adverse effects | - |
dc.subject.MESH | Cholesterol, LDL | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Dyslipidemias* / diagnosis | - |
dc.subject.MESH | Dyslipidemias* / drug therapy | - |
dc.subject.MESH | Ezetimibe / adverse effects | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects | - |
dc.subject.MESH | Hypercholesterolemia* / drug therapy | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Han Saem Jeong | - |
dc.contributor.googleauthor | Soon Jun Hong | - |
dc.contributor.googleauthor | Jin-Man Cho | - |
dc.contributor.googleauthor | Ki Hoon Han | - |
dc.contributor.googleauthor | Dong-Hun Cha | - |
dc.contributor.googleauthor | Sang-Ho Jo | - |
dc.contributor.googleauthor | Hyun-Jae Kang | - |
dc.contributor.googleauthor | So-Yeon Choi | - |
dc.contributor.googleauthor | Cheol Ung Choi | - |
dc.contributor.googleauthor | Eun Jeong Cho | - |
dc.contributor.googleauthor | Young-Hoon Jeong | - |
dc.contributor.googleauthor | Hyeon-Cheol Gwon | - |
dc.contributor.googleauthor | Byeong-Keuk Kim | - |
dc.contributor.googleauthor | Sung Yun Lee | - |
dc.contributor.googleauthor | Sang-Hyun Kim | - |
dc.contributor.googleauthor | Jeong Cheon Ahn | - |
dc.contributor.googleauthor | Young Joon Hong | - |
dc.contributor.googleauthor | Woo-Shik Kim | - |
dc.contributor.googleauthor | Seong-Ill Woo | - |
dc.contributor.googleauthor | Tae-Ho Park | - |
dc.contributor.googleauthor | Kyoo-Rok Han | - |
dc.identifier.doi | 10.1016/j.clinthera.2022.09.001 | - |
dc.contributor.localId | A00493 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 36241463 | - |
dc.subject.keyword | ezetimibe | - |
dc.subject.keyword | hypercholesterolemia | - |
dc.subject.keyword | pitavastatin | - |
dc.contributor.alternativeName | Kim, Byeong Keuk | - |
dc.contributor.affiliatedAuthor | 김병극 | - |
dc.citation.volume | 44 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 1310 | - |
dc.citation.endPage | 1325 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.44(10) : 1310-1325, 2022-10 | - |
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