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Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia

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dc.contributor.author홍범기-
dc.date.accessioned2024-03-22T06:10:20Z-
dc.date.available2024-03-22T06:10:20Z-
dc.date.issued2023-09-
dc.identifier.issn1524-6175-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/198434-
dc.description.abstractThe authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL-C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: −7.08%, 95% CI: −11.79 to −2.38, p =.0034, per-protocol analysis set [PPS]: −6.97%, 95% CI: −11.76 to −2.19, p =.0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: −10.13%, 95% CI: −15.41 to −4.84, p =.0002, PPS: −10.96%, 95% CI: −15.98 to −5.93, p <.0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207). © 2023 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherWiley Periodicals Inc.-
dc.relation.isPartOfJOURNAL OF CLINICAL HYPERTENSION-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAmlodipine / adverse effects-
dc.subject.MESHAtorvastatin / adverse effects-
dc.subject.MESHCholesterol, LDL-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDyslipidemias* / drug therapy-
dc.subject.MESHHumans-
dc.subject.MESHHypertension* / chemically induced-
dc.subject.MESHHypertension* / drug therapy-
dc.subject.MESHLeukemia, Myeloid, Acute* / chemically induced-
dc.subject.MESHRosuvastatin Calcium / adverse effects-
dc.subject.MESHTreatment Outcome-
dc.titleRandomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorHae Won Jung-
dc.contributor.googleauthorChang-Yeon Kim-
dc.contributor.googleauthorSeung-Pyo Hong-
dc.contributor.googleauthorHan-Joon Bae-
dc.contributor.googleauthorJi Yong Choi-
dc.contributor.googleauthorJae Kean Ryu-
dc.contributor.googleauthorJin-Bae Lee-
dc.contributor.googleauthorKyoung-Hoon Lee-
dc.contributor.googleauthorKyoo-Rok Han-
dc.contributor.googleauthorDong-Heon Yang-
dc.contributor.googleauthorChang-Gyu Park-
dc.contributor.googleauthorGheol-Woong Yu-
dc.contributor.googleauthorMoo-Yong Rhee-
dc.contributor.googleauthorSung-Ji Park-
dc.contributor.googleauthorMin-Su Hyon-
dc.contributor.googleauthorJoon-Han Shin-
dc.contributor.googleauthorBum-Kee Hong-
dc.contributor.googleauthorHan-Young Jin-
dc.contributor.googleauthorSung-Yun Lee-
dc.contributor.googleauthorSang-Hoon Seol-
dc.contributor.googleauthorSang-Rok Lee-
dc.contributor.googleauthorSong-Yi Kim-
dc.contributor.googleauthorKwang-Je Lee-
dc.contributor.googleauthorEun-Joo Cho-
dc.contributor.googleauthorChang-Wook Nam-
dc.contributor.googleauthorTae-Ho Park-
dc.contributor.googleauthorUng Kim-
dc.contributor.googleauthorKee-Sik Kim-
dc.identifier.doi10.1111/jch.14715-
dc.contributor.localIdA04394-
dc.relation.journalcodeJ01320-
dc.identifier.eissn1751-7176-
dc.identifier.pmid37584254-
dc.subject.keywordamlodipine-
dc.subject.keywordatorvastatin-
dc.subject.keyworddyslipidemia-
dc.subject.keywordhypertension-
dc.subject.keywordrosuvastatin-
dc.contributor.alternativeNameHong, Bum Kee-
dc.contributor.affiliatedAuthor홍범기-
dc.citation.volume25-
dc.citation.number9-
dc.citation.startPage828-
dc.citation.endPage844-
dc.identifier.bibliographicCitationJOURNAL OF CLINICAL HYPERTENSION, Vol.25(9) : 828-844, 2023-09-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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