Cited 0 times in Scipus Cited Count

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
dc.contributor.authorJeong, HS-
dc.contributor.authorHong, SJ-
dc.contributor.authorCho, JM-
dc.contributor.authorHan, KH-
dc.contributor.authorCha, DH-
dc.contributor.authorJo, SH-
dc.contributor.authorKang, HJ-
dc.contributor.authorChoi, SY-
dc.contributor.authorChoi, CU-
dc.contributor.authorCho, EJ-
dc.contributor.authorJeong, YH-
dc.contributor.authorGwon, HC-
dc.contributor.authorKim, BK-
dc.contributor.authorLee, SY-
dc.contributor.authorKim, SH-
dc.contributor.authorAhn, JC-
dc.contributor.authorHong, YJ-
dc.contributor.authorKim, WS-
dc.contributor.authorWoo, SI-
dc.contributor.authorPark, TH-
dc.contributor.authorHan, KR-
dc.date.accessioned2023-03-24T06:27:12Z-
dc.date.available2023-03-24T06:27:12Z-
dc.date.issued2022-
dc.identifier.issn0149-2918-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/25161-
dc.description.abstractPURPOSE: 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.language.isoen-
dc.subject.MESHAnticholesteremic Agents-
dc.subject.MESHCholesterol, LDL-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHDyslipidemias-
dc.subject.MESHEzetimibe-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHHydroxymethylglutaryl-CoA Reductase Inhibitors-
dc.subject.MESHHypercholesterolemia-
dc.subject.MESHMale-
dc.subject.MESHTreatment Outcome-
dc.titleA 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.typeArticle-
dc.identifier.pmid36241463-
dc.identifier.urlhttps://linkinghub.elsevier.com/retrieve/pii/S0149-2918(22)00315-0-
dc.subject.keywordezetimibe-
dc.subject.keywordhypercholesterolemia-
dc.subject.keywordpitavastatin-
dc.contributor.affiliatedAuthorChoi, SY-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.clinthera.2022.09.001-
dc.citation.titleClinical therapeutics-
dc.citation.volume44-
dc.citation.number10-
dc.citation.date2022-
dc.citation.startPage1310-
dc.citation.endPage1325-
dc.identifier.bibliographicCitationClinical therapeutics, 44(10). : 1310-1325, 2022-
dc.identifier.eissn1879-114X-
dc.relation.journalidJ001492918-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
Files in This Item:
36241463.pdfDownload

qrcode

해당 아이템을 이메일로 공유하기 원하시면 인증을 거치시기 바랍니다.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse