Cited 12 times in
Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan: A Randomized, Open-label, 3-period, Multiple-dose Crossover Study in Healthy Korean Male Subjects
DC Field | Value | Language |
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dc.contributor.author | 노혜랑 | - |
dc.contributor.author | 박경수 | - |
dc.contributor.author | 손한길 | - |
dc.contributor.author | 이동환 | - |
dc.date.accessioned | 2015-01-06T17:15:44Z | - |
dc.date.available | 2015-01-06T17:15:44Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/99644 | - |
dc.description.abstract | PURPOSE: Rosuvastatin has been widely used in combination with olmesartan for the treatment of dyslipidemia accompanied by hypertension. With no information currently available on the interaction between the 2 drugs, a pharmacokinetic study was conducted to investigate the influence of rosuvastatin on olmesartan and vice versa when the 2 drugs were coadministered. The purpose of this study was to investigate the pharmacokinetic profile of coadministration of the rosuvastatin 20-mg tablet and the olmesartan 40-mg tablet and the associated drug-drug interaction in healthy Korean male volunteers. METHODS: This was a randomized, open-label, 3-period, multiple-dose crossover study. Eligible subjects were aged 20 to 50 years and within 20% of their ideal body weight. After being randomly assigned to 6 groups of equal number, subjects received each of the following 3 formulations once a day for 7 consecutive days with an 8-day washout period between the formulations: rosuvastatin 20-mg tablet, olmesartan 40-mg tablet, and coadministration of the rosuvastatin 20-mg tablet and the olmesartan 40-mg tablet. Blood samples were collected up to 72 hours after dosing, and pharmacokinetic parameters were determined for rosuvastatin, its active metabolite (N-desmethyl rosuvastatin), and olmesartan. Adverse events were evaluated based on subject interviews and physical examinations. FINDINGS: Among the 36 enrolled subjects, 34 completed the study (mean [range] age, 28.6 [23-49] y; mean [range] weight, 66.4 [52.2-78.7] kg). The 90% CIs of the geometric mean ratios for the primary pharmacokinetic parameters for the coadministration of the 2 drugs to the mono-administration of each drug were 85.14% to 96.08% for AUCτ and 81.41% to 97.48% for Css,max for rosuvastatin, and 77.55% to 89.48% for AUCτ and 75.62% to 90.12% for Css,max for N-desmethyl rosuvastatin; those values were 95.61% to 102.57% for AUCτ and 91.73% to 102.98% for Css,max for olmesartan. Dizziness was the most frequently noted adverse drug reaction, occurring in 1 subject receiving mono-administration of rosuvastatin, 1 subject receiving mono-administration of olmesartan, and 4 subjects receiving coadministration of rosuvastatin and olmesartan. All the adverse events were expected, and there was no significant difference in the incidence between the 2 formulations. IMPLICATIONS: This study suggests that rosuvastatin and olmesartan did not significantly influence each other's pharmacokinetics when coadministered. Although the pharmacokinetics of N-desmethyl rosuvastatin were influenced by olmesartan, such interactions were considered clinically insignificant. All 3 formulations were well tolerated, and no serious adverse events or drug reactions were noted. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 1159~1170 | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Administration, Oral | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Antihypertensive Agents/administration & dosage | - |
dc.subject.MESH | Antihypertensive Agents/adverse effects | - |
dc.subject.MESH | Antihypertensive Agents/pharmacokinetics* | - |
dc.subject.MESH | Area Under Curve | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Drug Interactions | - |
dc.subject.MESH | Drug Therapy, Combination/adverse effects | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacokinetics* | - |
dc.subject.MESH | Imidazoles/administration & dosage | - |
dc.subject.MESH | Imidazoles/adverse effects | - |
dc.subject.MESH | Imidazoles/pharmacokinetics* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Rosuvastatin Calcium/administration & dosage | - |
dc.subject.MESH | Rosuvastatin Calcium/adverse effects | - |
dc.subject.MESH | Rosuvastatin Calcium/pharmacokinetics* | - |
dc.subject.MESH | Tetrazoles/administration & dosage | - |
dc.subject.MESH | Tetrazoles/adverse effects | - |
dc.subject.MESH | Tetrazoles/pharmacokinetics* | - |
dc.subject.MESH | Young Adult | - |
dc.title | Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan: A Randomized, Open-label, 3-period, Multiple-dose Crossover Study in Healthy Korean Male Subjects | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pharmacology (약리학) | - |
dc.contributor.googleauthor | Hyerang Roh | - |
dc.contributor.googleauthor | Hankil Son | - |
dc.contributor.googleauthor | Donghwan Lee | - |
dc.contributor.googleauthor | HeeChul Chang | - |
dc.contributor.googleauthor | Chohee Yun | - |
dc.contributor.googleauthor | Kyungsoo Park | - |
dc.identifier.doi | 10.1016/j.clinthera.2014.06.022 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01303 | - |
dc.contributor.localId | A01422 | - |
dc.contributor.localId | A01999 | - |
dc.contributor.localId | A02740 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 25017182 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0149291814003865 | - |
dc.subject.keyword | drug–drug interaction | - |
dc.subject.keyword | olmesartan | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | rosuvastatin | - |
dc.contributor.alternativeName | Roh, Hye Rang | - |
dc.contributor.alternativeName | Park, Kyung Soo | - |
dc.contributor.alternativeName | Son, Han kil | - |
dc.contributor.alternativeName | Lee, Dong Hwan | - |
dc.contributor.affiliatedAuthor | Roh, Hye Rang | - |
dc.contributor.affiliatedAuthor | Park, Kyung Soo | - |
dc.contributor.affiliatedAuthor | Son, Han kil | - |
dc.contributor.affiliatedAuthor | Lee, Dong Hwan | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 36 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1159 | - |
dc.citation.endPage | 1170 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.36(8) : 1159-1170, 2014 | - |
dc.identifier.rimsid | 56535 | - |
dc.type.rims | ART | - |
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