1. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial
- Author
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Boissonnat Pascale, Gaillard Ségolène, Mercier Catherine, Redonnet Michel, Lelong Bernard, Mattei Marie-Françoise, Mouly-Bandini Annick, Pattier Sabine, Sirinelli Agnès, Epailly Eric, Varnous Shaida, Billes Marc-Alain, Sebbag Laurent, Ecochard René, Cornu Catherine, and Gueyffier François
- Subjects
Calcineurin inhibition ,Cyclosporine A ,Heart transplantation ,Renal function ,Randomised clinical trial ,Medicine (General) ,R5-920 - Abstract
Abstract Background Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. Methods In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 Results At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. Conclusions In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. Trial registration ClinicalTrials.gov NCT00159159
- Published
- 2012
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