A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation

This prospective pharmacoepidemiological study examined treatment and outcomes in patients converted to sirolimus (SRL) after renal transplantation. 484 subjects in 36 centres in 7 countries were followed for up to 5 years. Principal reasons for conversion were declining graft function (146/484, 30%...

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Main Authors: Bertram L. Kasiske, Bjorn Nashan, Maria Del Carmen Rial, Pablo Raffaele, Graeme Russ, Josep Campistol, Mark D. Pescovitz, Paul A. Keown
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:Journal of Transplantation
Online Access:http://dx.doi.org/10.1155/2012/107180
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author Bertram L. Kasiske
Bjorn Nashan
Maria Del Carmen Rial
Pablo Raffaele
Graeme Russ
Josep Campistol
Mark D. Pescovitz
Paul A. Keown
author_facet Bertram L. Kasiske
Bjorn Nashan
Maria Del Carmen Rial
Pablo Raffaele
Graeme Russ
Josep Campistol
Mark D. Pescovitz
Paul A. Keown
author_sort Bertram L. Kasiske
collection DOAJ
description This prospective pharmacoepidemiological study examined treatment and outcomes in patients converted to sirolimus (SRL) after renal transplantation. 484 subjects in 36 centres in 7 countries were followed for up to 5 years. Principal reasons for conversion were declining graft function (146/484, 30%) and side effects of prior therapy (144/484, 30%) and the major treatment combinations after conversion were SRL ± MMF (62%), SRL + TAC (21.5%), SRL + CSA (16.5%). The cumulative probability of biopsy-confirmed acute rejection (BCAR) was 5% (n=22), death-censored graft loss 12% (n=56) and death 6% (n=22), and there was no significant relationship to the treatment combination employed. Median calculated creatinine clearance was 48.4 (29.3, 64.5) mL/min at conversion, rising to 54.1 (41.2, 69.0) mL/min at month 1, 55.7 (39.0, 73.0) mL/min at month 12, 58.6 (39.7, 75.2) mL/min at two years and 60.9 (36.0, 77.0) mL/min at three years post-conversion. The most common adverse events were hypertension (47%), hyperlipidemia (26%), urinary tract infections (25%), anaemia (24%) and diarrhea (14%), and cardiac events, hyperlipemia and CMV infection were more common in patients converted during the first year. SRL was most frequently combined with MMF after conversion, but principal clinical outcomes were not significantly influenced by the treatment combination employed in normal practice.
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spelling doaj-art-b2afb205132247a5bd3047fd0ca0bc032025-02-03T05:52:53ZengWileyJournal of Transplantation2090-00072090-00152012-01-01201210.1155/2012/107180107180A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal TransplantationBertram L. Kasiske0Bjorn Nashan1Maria Del Carmen Rial2Pablo Raffaele3Graeme Russ4Josep Campistol5Mark D. Pescovitz6Paul A. Keown7Division of Nephrology, Hennepin County Medical Center, Minneapolis, MN 55415, USAUniversity Medical Center Hamburg-Eppendorf, Hamburg, GermanyInstituto de Nefrología, Buenos Aires, ArgentinaFundación Favaloro, Buenos Aires, ArgentinaThe Queen Elizabeth Hospital, Adelaide, SA, AustraliaRenal Transplant Unit, Hospital Clinic University of Barcelona, Barcelona, SpainIndiana University School of Medicine, Indianapolis, IN, USAUniversity of British Columbia and Syreon Corporation, Vancouver, BC, CanadaThis prospective pharmacoepidemiological study examined treatment and outcomes in patients converted to sirolimus (SRL) after renal transplantation. 484 subjects in 36 centres in 7 countries were followed for up to 5 years. Principal reasons for conversion were declining graft function (146/484, 30%) and side effects of prior therapy (144/484, 30%) and the major treatment combinations after conversion were SRL ± MMF (62%), SRL + TAC (21.5%), SRL + CSA (16.5%). The cumulative probability of biopsy-confirmed acute rejection (BCAR) was 5% (n=22), death-censored graft loss 12% (n=56) and death 6% (n=22), and there was no significant relationship to the treatment combination employed. Median calculated creatinine clearance was 48.4 (29.3, 64.5) mL/min at conversion, rising to 54.1 (41.2, 69.0) mL/min at month 1, 55.7 (39.0, 73.0) mL/min at month 12, 58.6 (39.7, 75.2) mL/min at two years and 60.9 (36.0, 77.0) mL/min at three years post-conversion. The most common adverse events were hypertension (47%), hyperlipidemia (26%), urinary tract infections (25%), anaemia (24%) and diarrhea (14%), and cardiac events, hyperlipemia and CMV infection were more common in patients converted during the first year. SRL was most frequently combined with MMF after conversion, but principal clinical outcomes were not significantly influenced by the treatment combination employed in normal practice.http://dx.doi.org/10.1155/2012/107180
spellingShingle Bertram L. Kasiske
Bjorn Nashan
Maria Del Carmen Rial
Pablo Raffaele
Graeme Russ
Josep Campistol
Mark D. Pescovitz
Paul A. Keown
A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
Journal of Transplantation
title A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
title_full A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
title_fullStr A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
title_full_unstemmed A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
title_short A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
title_sort prospective multinational pharmacoepidemiological study of clinical conversion to sirolimus immunosuppression after renal transplantation
url http://dx.doi.org/10.1155/2012/107180
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