Safety of Neoral conversion in maintenance renal transplant patients: A one-year, double-blind study

Safety of Neoral conversion in maintenance renal transplant patients: A one-year, double-blind study.Despite the improved pharmacokinetic characteristics of Neoral, some centers have encountered difficulty with the conversion of some patients from Sandimmune to Neoral and have reported precipitation of toxicity and rejection.We conducted a randomized, double-blind, parallel-group, multicenter prospective study of stable maintenance renal transplant patients to compare the safety and tolerability of converting from Sandimmune to Neoral ( = 132) versus continuing Sandimmune ( = 130). Patients were studied for one year. The cyclosporine (CsA) dose was adjusted as necessary to maintain site-specific trough whole blood levels.During the study, dose adjustments were frequent in both groups: 67% Neoral versus 65% Sandimmune patients. At study completion, the mean trough CsA levels were comparable; the dose change-from-baseline did not differ statistically between groups. Fewer Neoral (87.1%) than Sandimmune (95.4%) patients reported adverse events, and serious adverse events were comparable. Adverse events related to CsA were not more common in the Neoral group. Renal function measures also implied comparability of the two treatments. Three Neoral versus five Sandimmune patients experienced acute rejection; two Neoral versus five Sandimmune patients experienced chronic graft dysfunction. Two septic deaths occurred in the Neoral group. No grafts were lost.With careful monitoring, conversion of maintenance renal transplant patients to Neoral can be safely accomplished.

新山地明转换在维持性肾移植患者中的安全性：一项为期一年的双盲研究。尽管新山地明具有更优的药代动力学特性，但一些中心在将部分患者从山地明转换为新山地明时遇到困难，并报告出现毒性反应和排斥反应。我们对病情稳定的维持性肾移植患者进行了一项随机、双盲、平行分组、多中心前瞻性研究，以比较从山地明转换为新山地明（n = 132）与继续使用山地明（n = 130）的安全性和耐受性。对患者进行了为期一年的研究。根据需要调整环孢素（CsA）剂量，以维持特定部位的全血谷浓度。在研究期间，两组都频繁调整剂量：新山地明组为67%，山地明组为65%。研究结束时，平均CsA谷浓度相当；两组间从基线起的剂量变化无统计学差异。报告不良事件的新山地明组患者（87.1%）少于山地明组（95.4%），严重不良事件相当。与CsA相关的不良事件在新山地明组并不更常见。肾功能指标也表明两种治疗方法具有可比性。新山地明组有3例患者发生急性排斥反应，山地明组有5例；新山地明组有2例患者出现慢性移植物功能障碍，山地明组有5例。新山地明组有2例患者因败血症死亡。无移植物丢失。通过仔细监测，维持性肾移植患者可安全地转换为新山地明。