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Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial

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dc.contributor.authorKim, Byung Jin-
dc.contributor.authorCha, Kwang Soo-
dc.contributor.authorCho, Wook Hyun-
dc.contributor.authorKim, Eung Ju-
dc.contributor.authorChoi, Seung-Hyuk-
dc.contributor.authorKim, Moo Hyun-
dc.contributor.authorKim, Sang-Hyun-
dc.contributor.authorPark, Jun-Bean-
dc.contributor.authorPark, Seong-Mi-
dc.contributor.authorSohn, Il Suk-
dc.contributor.authorRyu, Kyu Hyung-
dc.contributor.authorChae, In-Ho-
dc.date.accessioned2023-11-15T00:40:09Z-
dc.date.available2023-11-15T00:40:09Z-
dc.date.issued2023-10-
dc.identifier.issn1074-2484-
dc.identifier.issn1940-4034-
dc.identifier.urihttps://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/64306-
dc.description.abstractIntroduction: This study evaluated the efficacy and safety of a single-pill triple-combination of olmesartan/amlodipine/rosuvastatin (Olme/Amlo/Rosu) in comparison with a single-pill dual-combination of olmesartan/amlodipine (Olme/Amlo) in hypertensive patients with low-to-moderate cardiovascular risk.Methods: This multicenter, active-control, randomized study included 106 hypertensive patients at low-to-moderate cardiovascular risk who were randomly assigned to receive either Olme/Amlo/Rosu 20/5/5 mg (Treatment 1), Olme/Amlo/Rosu 20/5/10 mg (Treatment 2), or Amlo/Olme 20/5 mg (Control) once daily for 8 weeks. The primary endpoint was the difference of the percent change in low-density lipoprotein cholesterol (LDL-C) level at 8 weeks from baseline in the 3 groups.Results: The difference in the least square mean percent change (standard deviation) of LDL-C in the Treatment 1 and 2 groups compared with the Control group at 8 weeks was -32.6 (3.7) % and -45.9 (3.3) %, respectively (P < .001). The achievement rates of LDL-C level <100 mg/dL at 8 weeks were significantly different between the 3 groups (65.8%, 86.7%, and 6.3% for Treatment 1, 2, and Control groups, respectively, P < .001). The results of total cholesterol, triglycerides, high-density lipoprotein cholesterol, apolipoprotein B, and apolipoprotein B/apolipoprotein A1 were superior in the Treatment 1 and 2 groups compared with the Control group. Serious adverse drug reaction did not occur in the 3 groups. Medication adherence rates were excellent in the 3 groups (98.0% for Treatment 1 group, 99.7% for Treatment 2 group, and 96.3% for the Control group, P > .05).Conclusion: Single-pill triple-combination of olmesartan/amlodipine/rosuvastatin was superior to the single-pill dual-combination of amlodipine/olmesartan in LDLC-lowering effects, with excellent safety profiles and adherence rates, in hypertensive patients at low-to-moderate cardiovascular risk. Trial Registration:-
dc.language영어-
dc.language.isoENG-
dc.publisherSAGE Publications-
dc.titleEfficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial-
dc.typeArticle-
dc.publisher.location미국-
dc.identifier.doi10.1177/10742484231205204-
dc.identifier.scopusid2-s2.0-85173685458-
dc.identifier.wosid001083430100001-
dc.identifier.bibliographicCitationJournal of Cardiovascular Pharmacology and Therapeutics, v.28-
dc.citation.titleJournal of Cardiovascular Pharmacology and Therapeutics-
dc.citation.volume28-
dc.type.docTypeArticle-
dc.description.isOpenAccessY-
dc.description.journalRegisteredClassscie-
dc.description.journalRegisteredClassscopus-
dc.relation.journalResearchAreaCardiovascular System & Cardiology-
dc.relation.journalResearchAreaPharmacology & Pharmacy-
dc.relation.journalWebOfScienceCategoryCardiac & Cardiovascular Systems-
dc.relation.journalWebOfScienceCategoryPharmacology & Pharmacy-
dc.subject.keywordPlusSTATIN THERAPY-
dc.subject.keywordPlusBLOOD-PRESSURE-
dc.subject.keywordPlusDOUBLE-BLIND-
dc.subject.keywordPlusMETAANALYSIS-
dc.subject.keywordPlusMEDOXOMIL-
dc.subject.keywordAuthordyslipidemia-
dc.subject.keywordAuthorhypertension-
dc.subject.keywordAuthorlow-density lipoprotein cholesterol-
dc.subject.keywordAuthorrandomized controlled trial-
dc.subject.keywordAuthorsingle-pill combination-
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