Journal article
Randomized Controlled Trial of Sirolimus Conversion in Cardiac Transplant Recipients With Renal Insufficiency
American journal of transplantation, v 12(9), pp 2487-2497
01 Sep 2012
PMID: 22776430
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
This randomized, comparative, multinational phase 3b/4 study of patients 18 years postcardiac transplantation (mean 3.9 years) evaluated the effect of conversion from a calcineurin inhibitor (CNI) to sirolimus on renal function in patients with renal insufficiency. In total, 116 patients on CNI therapy with GFR 4090 mL/min/1.73m2 were randomized (1:1) to sirolimus (n = 57) or CNI (n = 59). Intent-to-treat analysis showed the 1-year adjusted mean change from baseline in creatinine clearance (Cockcroft-Gault) was significantly higher with sirolimus versus CNI treatment (+3.0 vs. -1.4 mL/min/1.73 m2, respectively; p = 0.004). By on-therapy analysis, values were +4.7 and 2.1, respectively (p < 0.001). Acute rejection (AR) rates were numerically higher in the sirolimus group; 1 AR with hemodynamic compromise occurred in each group. A significantly higher treatment discontinuation rate due to adverse events (AEs; 33.3% vs. 0%; p < 0.001) occurred in the sirolimus group. Most common treatment-emergent AEs significantly higher in the sirolimus group were diarrhea (28.1%), rash (28.1%) and infection (47.4%). Conversion to sirolimus from CNI therapy improved renal function in cardiac transplant recipients with renal impairment, but was associated with an attendant AR risk and higher discontinuation rate attributable to AEs.
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Details
- Title
- Randomized Controlled Trial of Sirolimus Conversion in Cardiac Transplant Recipients With Renal Insufficiency
- Creators
- A. Zuckermann - Arbeitsgemeinschaft für Klinische ErnährungAnne Keogh - St Vincent's Hospital SydneyM. G. Crespo-Leiro - Universidade da CoruñaD. Mancini - Columbia UniversityF. Gonzalez Vilchez - Marqués de Valdecilla University HospitalL. Almenar - Hospital Universitario La FeS. Brozena - University of PennsylvaniaH. Eisen - Drexel UniversityS. See Tai - Pfizer,S. Kushwaha - MAYO CLINIC ROCHESTER, Rochester, MN
- Publication Details
- American journal of transplantation, v 12(9), pp 2487-2497
- Publisher
- Wiley
- Number of pages
- 11
- Grant note
- GSK; GlaxoSmithKline NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA Gilead; Gilead Sciences Bayer; Bayer AG Astellas; Astellas Pharmaceuticals Pfizer Inc; Pfizer Novartis Actolion Wyeth Pharmaceuticals; Wyeth Eli Lilly
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000307945000027
- Scopus ID
- 2-s2.0-84865582428
- Other Identifier
- 991019335513504721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Surgery
- Transplantation