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Journal of Transplantation
Volume 2012 (2012), Article ID 107180, 16 pages
http://dx.doi.org/10.1155/2012/107180
Clinical Study

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

1Division of Nephrology, Hennepin County Medical Center, Minneapolis, MN 55415, USA
2University Medical Center Hamburg-Eppendorf, Hamburg, Germany
3Instituto de Nefrología, Buenos Aires, Argentina
4Fundación Favaloro, Buenos Aires, Argentina
5The Queen Elizabeth Hospital, Adelaide, SA, Australia
6Renal Transplant Unit, Hospital Clinic University of Barcelona, Barcelona, Spain
7Indiana University School of Medicine, Indianapolis, IN, USA
8University of British Columbia and Syreon Corporation, Vancouver, BC, Canada

Received 28 December 2011; Accepted 3 May 2012

Academic Editor: Andreas Zuckermann

Copyright © 2012 Bertram L. Kasiske et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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 = 2 2 ), death-censored graft loss 12% ( 𝑛 = 5 6 ) and death 6% ( 𝑛 = 2 2 ), 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.