Effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study
Data comparing long‐term effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR‐Tac (Advagraf) for up to 12 months post‐transplant. Adult de novo liver tr...
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| Veröffentlicht in: | Clinical transplantation 2023-12, Vol.37 (12), p.e15105-n/a |
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| creator | Bilbao, Itxarone Gómez Bravo, Miguel Ángel Otero, Alejandra Lladó, Laura Montero, José Luís González Dieguez, Luisa Graus, Javier Pons Miñano, José Antonio |
| description | Data comparing long‐term effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR‐Tac (Advagraf) for up to 12 months post‐transplant. Adult de novo liver transplant recipients who started IR‐Tac (Prograf) and were converted to LCPT or PR‐Tac 3–5 days post‐transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR‐Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR‐Tac group (p = .291). Biopsy‐proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR‐Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (Cmin/total daily dose [TDD]; p |
| doi_str_mv | 10.1111/ctr.15105 |
| format | Article |
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We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR‐Tac (Advagraf) for up to 12 months post‐transplant. Adult de novo liver transplant recipients who started IR‐Tac (Prograf) and were converted to LCPT or PR‐Tac 3–5 days post‐transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR‐Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR‐Tac group (p = .291). Biopsy‐proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR‐Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (Cmin/total daily dose [TDD]; p < .01) with similar Cmin and 33.3% lower TDD versus PR‐Tac (p < .01). The evolution of renal function, safety profile, and the incidence of post‐transplant renal failure, dyslipidemia, obesity, hypertension, and diabetes mellitus were similar in patients treated with LCPT and PR‐Tac. In de novo liver transplant patients, LCPT and PR‐Tac showed comparable effectiveness with higher relative bioavailability, similar Cmin and lower TDD in the LCPT group. Renal function, safety, and post‐transplant complications were comparable in LCPT and PR‐Tac groups.</description><identifier>ISSN: 0902-0063</identifier><identifier>EISSN: 1399-0012</identifier><identifier>DOI: 10.1111/ctr.15105</identifier><identifier>PMID: 37615653</identifier><language>eng</language><publisher>Denmark</publisher><subject>Adult ; Drug Administration Schedule ; Graft Rejection - drug therapy ; Graft Rejection - etiology ; Humans ; Immunosuppressive Agents - pharmacokinetics ; Immunosuppressive Agents - therapeutic use ; Kidney Transplantation - adverse effects ; liver transplant ; Liver Transplantation ; pharmacokinetics ; Prospective Studies ; safety ; tacrolimus ; Tacrolimus - pharmacokinetics ; Tacrolimus - therapeutic use ; Transplant Recipients ; treatment failure</subject><ispartof>Clinical transplantation, 2023-12, Vol.37 (12), p.e15105-n/a</ispartof><rights>2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2855-b723aeefa40c269563e35584945a08ef9b9270b298beacf2c2fa6eec5bfe66d03</cites><orcidid>0000-0002-7389-395X ; 0000-0002-9016-3705</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.15105$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fctr.15105$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37615653$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bilbao, Itxarone</creatorcontrib><creatorcontrib>Gómez Bravo, Miguel Ángel</creatorcontrib><creatorcontrib>Otero, Alejandra</creatorcontrib><creatorcontrib>Lladó, Laura</creatorcontrib><creatorcontrib>Montero, José Luís</creatorcontrib><creatorcontrib>González Dieguez, Luisa</creatorcontrib><creatorcontrib>Graus, Javier</creatorcontrib><creatorcontrib>Pons Miñano, José Antonio</creatorcontrib><title>Effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study</title><title>Clinical transplantation</title><addtitle>Clin Transplant</addtitle><description>Data comparing long‐term effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR‐Tac (Advagraf) for up to 12 months post‐transplant. Adult de novo liver transplant recipients who started IR‐Tac (Prograf) and were converted to LCPT or PR‐Tac 3–5 days post‐transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR‐Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR‐Tac group (p = .291). Biopsy‐proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR‐Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (Cmin/total daily dose [TDD]; p < .01) with similar Cmin and 33.3% lower TDD versus PR‐Tac (p < .01). The evolution of renal function, safety profile, and the incidence of post‐transplant renal failure, dyslipidemia, obesity, hypertension, and diabetes mellitus were similar in patients treated with LCPT and PR‐Tac. In de novo liver transplant patients, LCPT and PR‐Tac showed comparable effectiveness with higher relative bioavailability, similar Cmin and lower TDD in the LCPT group. Renal function, safety, and post‐transplant complications were comparable in LCPT and PR‐Tac groups.</description><subject>Adult</subject><subject>Drug Administration Schedule</subject><subject>Graft Rejection - drug therapy</subject><subject>Graft Rejection - etiology</subject><subject>Humans</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Transplantation - adverse effects</subject><subject>liver transplant</subject><subject>Liver Transplantation</subject><subject>pharmacokinetics</subject><subject>Prospective Studies</subject><subject>safety</subject><subject>tacrolimus</subject><subject>Tacrolimus - pharmacokinetics</subject><subject>Tacrolimus - therapeutic use</subject><subject>Transplant Recipients</subject><subject>treatment failure</subject><issn>0902-0063</issn><issn>1399-0012</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMtOAyEUQInRaH0s_AHDUhdVYAot7kxTrYmJpqnrCcNcImYGKjA1s_MT_Ea_RLTqTjYQcnJy70HomJJzms-FTuGcckr4FhrQQsohIZRtowGRhOW3KPbQfozP-VdQwXfRXjEWlAteDFA_MwZ0smtwECNWrsZRGUg99gZ7p-Hj7b1WtulxUjr4xrZdxMaHtmtUst5FbB2uATu_9rjJmoBTUC6uGuUSDqDtyoJL8RIvnwA_LGbL-S2Oqav7Q7RjVBPh6Oc-QI_Xs-V0Pry7v7mdXt0NNZtwPqzGrFAARo2IZkJyUUDB-WQkR1yRCRhZSTYmFZOTCpQ2TDOjBIDmlQEhalIcoNONdxX8Swcxla2NGpo8IPgulixHklyOpMzo2QbNm8YYwJSrYFsV-pKS8qt0mUuX36Uze_Kj7aoW6j_yN20GLjbAq22g_99UTpeLjfIT_maLGQ</recordid><startdate>202312</startdate><enddate>202312</enddate><creator>Bilbao, Itxarone</creator><creator>Gómez Bravo, Miguel Ángel</creator><creator>Otero, Alejandra</creator><creator>Lladó, Laura</creator><creator>Montero, José Luís</creator><creator>González Dieguez, Luisa</creator><creator>Graus, Javier</creator><creator>Pons Miñano, José Antonio</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7389-395X</orcidid><orcidid>https://orcid.org/0000-0002-9016-3705</orcidid></search><sort><creationdate>202312</creationdate><title>Effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study</title><author>Bilbao, Itxarone ; Gómez Bravo, Miguel Ángel ; Otero, Alejandra ; Lladó, Laura ; Montero, José Luís ; González Dieguez, Luisa ; Graus, Javier ; Pons Miñano, José Antonio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2855-b723aeefa40c269563e35584945a08ef9b9270b298beacf2c2fa6eec5bfe66d03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Drug Administration Schedule</topic><topic>Graft Rejection - drug therapy</topic><topic>Graft Rejection - etiology</topic><topic>Humans</topic><topic>Immunosuppressive Agents - pharmacokinetics</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney Transplantation - adverse effects</topic><topic>liver transplant</topic><topic>Liver Transplantation</topic><topic>pharmacokinetics</topic><topic>Prospective Studies</topic><topic>safety</topic><topic>tacrolimus</topic><topic>Tacrolimus - pharmacokinetics</topic><topic>Tacrolimus - therapeutic use</topic><topic>Transplant Recipients</topic><topic>treatment failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bilbao, Itxarone</creatorcontrib><creatorcontrib>Gómez Bravo, Miguel Ángel</creatorcontrib><creatorcontrib>Otero, Alejandra</creatorcontrib><creatorcontrib>Lladó, Laura</creatorcontrib><creatorcontrib>Montero, José Luís</creatorcontrib><creatorcontrib>González Dieguez, Luisa</creatorcontrib><creatorcontrib>Graus, Javier</creatorcontrib><creatorcontrib>Pons Miñano, José Antonio</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bilbao, Itxarone</au><au>Gómez Bravo, Miguel Ángel</au><au>Otero, Alejandra</au><au>Lladó, Laura</au><au>Montero, José Luís</au><au>González Dieguez, Luisa</au><au>Graus, Javier</au><au>Pons Miñano, José Antonio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study</atitle><jtitle>Clinical transplantation</jtitle><addtitle>Clin Transplant</addtitle><date>2023-12</date><risdate>2023</risdate><volume>37</volume><issue>12</issue><spage>e15105</spage><epage>n/a</epage><pages>e15105-n/a</pages><issn>0902-0063</issn><eissn>1399-0012</eissn><abstract>Data comparing long‐term effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR‐Tac (Advagraf) for up to 12 months post‐transplant. Adult de novo liver transplant recipients who started IR‐Tac (Prograf) and were converted to LCPT or PR‐Tac 3–5 days post‐transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR‐Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR‐Tac group (p = .291). Biopsy‐proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR‐Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR‐Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (Cmin/total daily dose [TDD]; p < .01) with similar Cmin and 33.3% lower TDD versus PR‐Tac (p < .01). The evolution of renal function, safety profile, and the incidence of post‐transplant renal failure, dyslipidemia, obesity, hypertension, and diabetes mellitus were similar in patients treated with LCPT and PR‐Tac. In de novo liver transplant patients, LCPT and PR‐Tac showed comparable effectiveness with higher relative bioavailability, similar Cmin and lower TDD in the LCPT group. Renal function, safety, and post‐transplant complications were comparable in LCPT and PR‐Tac groups.</abstract><cop>Denmark</cop><pmid>37615653</pmid><doi>10.1111/ctr.15105</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-7389-395X</orcidid><orcidid>https://orcid.org/0000-0002-9016-3705</orcidid></addata></record> |
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| subjects | Adult Drug Administration Schedule Graft Rejection - drug therapy Graft Rejection - etiology Humans Immunosuppressive Agents - pharmacokinetics Immunosuppressive Agents - therapeutic use Kidney Transplantation - adverse effects liver transplant Liver Transplantation pharmacokinetics Prospective Studies safety tacrolimus Tacrolimus - pharmacokinetics Tacrolimus - therapeutic use Transplant Recipients treatment failure |
| title | Effectiveness and safety of once‐daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study |
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