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
DC Field | Value | Language |
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dc.contributor.author | Kim, Byung Jin | - |
dc.contributor.author | Cha, Kwang Soo | - |
dc.contributor.author | Cho, Wook Hyun | - |
dc.contributor.author | Kim, Eung Ju | - |
dc.contributor.author | Choi, Seung-Hyuk | - |
dc.contributor.author | Kim, Moo Hyun | - |
dc.contributor.author | Kim, Sang-Hyun | - |
dc.contributor.author | Park, Jun-Bean | - |
dc.contributor.author | Park, Seong-Mi | - |
dc.contributor.author | Sohn, Il Suk | - |
dc.contributor.author | Ryu, Kyu Hyung | - |
dc.contributor.author | Chae, In-Ho | - |
dc.date.accessioned | 2023-11-15T00:40:09Z | - |
dc.date.available | 2023-11-15T00:40:09Z | - |
dc.date.issued | 2023-10 | - |
dc.identifier.issn | 1074-2484 | - |
dc.identifier.issn | 1940-4034 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/64306 | - |
dc.description.abstract | Introduction: 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.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | SAGE Publications | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.1177/10742484231205204 | - |
dc.identifier.scopusid | 2-s2.0-85173685458 | - |
dc.identifier.wosid | 001083430100001 | - |
dc.identifier.bibliographicCitation | Journal of Cardiovascular Pharmacology and Therapeutics, v.28 | - |
dc.citation.title | Journal of Cardiovascular Pharmacology and Therapeutics | - |
dc.citation.volume | 28 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Cardiovascular System & Cardiology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Cardiac & Cardiovascular Systems | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | STATIN THERAPY | - |
dc.subject.keywordPlus | BLOOD-PRESSURE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | METAANALYSIS | - |
dc.subject.keywordPlus | MEDOXOMIL | - |
dc.subject.keywordAuthor | dyslipidemia | - |
dc.subject.keywordAuthor | hypertension | - |
dc.subject.keywordAuthor | low-density lipoprotein cholesterol | - |
dc.subject.keywordAuthor | randomized controlled trial | - |
dc.subject.keywordAuthor | single-pill combination | - |
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