A prospective, randomized clinical trial of cyclosporine reduction in stable patients greater than 12 months after renal transplantation

Détails

ID Serval
serval:BIB_517533958AFC
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
A prospective, randomized clinical trial of cyclosporine reduction in stable patients greater than 12 months after renal transplantation
Périodique
Transplantation
Auteur(s)
Pascual  M., Curtis  J., Delmonico  F. L., Farrell  M. L., Williams, W. W., Jr. , Kalil  R., Jones  P., Cosimi  A. B., Tolkoff-Rubin  N.
ISSN
0041-1337
Statut éditorial
Publié
Date de publication
05/2003
Peer-reviewed
Oui
Volume
75
Numéro
9
Pages
1501-5
Notes
Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: May 15
Résumé
BACKGROUND: For stable kidney-transplant recipients receiving triple drug therapy with cyclosporine (CsA), prednisone, and mycophenolate mofetil (MMF), it remains unclear what is the optimal dose of CsA beyond the first 6 to 12 months after transplantation. Complete CsA withdrawal has been associated with a significant incidence of acute rejection and, in some studies, chronic rejection as well. METHODS: We performed an open, prospectively randomized, controlled clinical trial to determine whether CsA could be safely reduced by 50%. At 1 year or more posttransplant, 64 patients were randomized to either continue their stable-maintenance CsA dose (control group, n=32) or to lower their CsA dose by 50% over a 2 month period (CsA reduction group, n=32). All patients had stable renal-allograft function at the time of enrollment. RESULTS: Within 6 months of randomization, no episode of acute rejection or graft loss occurred in either group. Patients in the CsA reduction group had a slight but significant increase in their glomerular filtration rate and a trend towards lower serum creatinine. There was also a significant decrease in mean systolic blood pressure, triglycerides, and serum uric acid levels in the CsA reduction group. No significant changes in any of these parameters were observed in the control group. CONCLUSIONS: This study suggests that a strategy consisting of a 50% CsA reduction is safe and is not associated with the increased risk of acute rejection observed in CsA withdrawal studies. It also has the potential to improve short-term allograft function and appears to reduce cardiovascular risk factors such as hypertension and hyperlipidemia.
Mots-clé
Adult Cyclosporine/*administration & dosage Female Graft Rejection Humans Immunosuppressive Agents/*administration & dosage *Kidney Transplantation Male Middle Aged Mycophenolic Acid/administration & dosage/analogs & derivatives Prospective Studies Time Factors Transplantation, Homologous
Pubmed
Web of science
Création de la notice
29/01/2008 14:52
Dernière modification de la notice
03/03/2018 17:11
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