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https://dipositint.ub.edu/dspace/handle/2445/208137
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DC Field | Value | Language |
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dc.contributor.author | Montero Pérez, Núria | - |
dc.contributor.author | Fontova, Pere | - |
dc.contributor.author | Colom Codina, Helena | - |
dc.contributor.author | Rigo Bonnin, Raúl | - |
dc.contributor.author | Bestard Matamoros, Oriol | - |
dc.contributor.author | Vidal Alabró, Anna | - |
dc.contributor.author | van Merendonk, Lisanne | - |
dc.contributor.author | Cerezo, Gema | - |
dc.contributor.author | Polo, Carolina | - |
dc.contributor.author | Melilli, Edoardo | - |
dc.contributor.author | Manonelles, Anna | - |
dc.contributor.author | Meneghini, Maria | - |
dc.contributor.author | Coloma, Ana | - |
dc.contributor.author | Cruzado, Josep Ma. | - |
dc.contributor.author | Torras Ambròs, Joan | - |
dc.contributor.author | Grinyó Boira, Josep M. | - |
dc.contributor.author | Lloberas Blanch, Núria | - |
dc.date.accessioned | 2024-02-27T18:33:12Z | - |
dc.date.available | 2024-02-27T18:33:12Z | - |
dc.date.issued | 2021-02-24 | - |
dc.identifier.issn | 0009-9236 | - |
dc.identifier.uri | http://hdl.handle.net/2445/208137 | - |
dc.description.abstract | Tacrolimus (Tac) is the cornerstone calcineurin inhibitor in transplantation. Extended-release Meltdose formulation (Tac-LCP) offers better bioavailability compared with immediate-release formulation (Tac-IR). We postulated that the less fluctuating pharmacokinetic (PK) profile of Tac-LCP might maintain a sustained inhibition of calcineurin activity (CNA) between dose intervals. Higher concentrations (peak plasma concentration (Cmax )) after Tac-IR may not result in a more potent CNA inhibition due to a capacity-limited effect. This study was aimed at evaluating the pharmacodynamic (PD)/PK profiles of Tac-IR compared with Tac-LCP. An open-label, prospective, nonrandomized, investigator-driven study was conducted. Twenty-five kidney transplant recipients receiving Tac-IR were switched to Tac-LCP. Before and 28 days after conversion, intensive CNA-PD and PK sampling were conducted using ultra-high-performance liquid chromatography-tandem accurate mass spectrometry. PD nonlinear mixed effects model was performed in Phoenix-WinNonlin. Statistically significant higher Cmax (P < 0.001) after Tac-IR did not result in lower CNA as compared with after Tac-LCP (P = 0.860). Tac-LCP showed a statistically more maintained CNA inhibition between dose intervals (area under the effect-time curve from 0 to 24 hours (AUE0-24h )) compared with Tac-IR, in which CNA returned to predose levels after 4 hours of drug intake (373.8 vs. 290.5 pmol RII·h/min·mg prot, Tac-LCP vs. Tac-IR; P = 0.039). No correlation was achieved between any PD and PK parameters in any formulations. Moreover, Tac concentration to elicit a 50% of the maximum response (half-maximal inhibitory concentration) was 9.24 ng/mL. The higher Cmax after Tac-IR does not result in an additional CNA inhibition compared with Tac-LCP attributable to a capacity-limited effect. Tac-LCP may represent an improvement of the PD of Tac due to the more sustained CNA inhibition during dose intervals. | - |
dc.format.extent | 43 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | John Wiley & Sons | - |
dc.relation.isformatof | Versió postprint del document publicat a: https://doi.org/10.1002/cpt.2220 | - |
dc.relation.ispartof | Clinical Pharmacology & Therapeutics, 2021, vol. 110, num.1, p. 238-247 | - |
dc.relation.uri | https://doi.org/10.1002/cpt.2220 | - |
dc.rights | (c) American Society for Clinical Pharmacology and Therapeutics, 2021 | - |
dc.source | Articles publicats en revistes (Infermeria Fonamental i Clínica) | - |
dc.subject.classification | Immunosupressors | - |
dc.subject.classification | Trasplantament renal | - |
dc.subject.classification | Cromatografia | - |
dc.subject.other | Immunosupressive agents | - |
dc.subject.other | Kidney transplantation | - |
dc.subject.other | Chromatography | - |
dc.title | Sustained inhibition of calcineurin activity with a Melt‐Dose Once‐daily Tacrolimus formulation in renal transplant recipients | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/acceptedVersion | - |
dc.identifier.idgrec | 711422 | - |
dc.date.updated | 2024-02-27T18:33:12Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 33626199 | - |
Appears in Collections: | Articles publicats en revistes (Infermeria Fonamental i Clínica) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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238820.pdf | 796.49 kB | Adobe PDF | View/Open |
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