Juárez F, Cano L, Camacho R, Adame B, Solís M, Maciel M, Borjón S, Barrios Y

Language: Spanish
References: 16
Page: 493-499
PDF size: 226.50 Kb.

ABSTRACT

Introduction: the study was designed to evaluate the clinical results of Zaven ME in stable renal transplantation.
Objective: to evaluate safety and efficacy of cyclosporine in microemulsion Zaven ME in kidney transplant patients receiving schemes with Neoral.
Methods: fifty-three patients fulfilled the inclusion criteria as follows: males or females between 5 and 70 years of age; patients receiving Neoral for at least 6 months, and those who provided signed informed consent. A follow-up of 6 months marked the end of the study. Neoral was changed with a 25 % dose reduction per week and combined Zaven ME with the corresponding dose; 100 % Neoral was given at basal time and 100 % Zaven ME during the first month of the study.
Results: There were no differences between gender, 25 males and 28 females, 45 ± 14 years of age in both groups; 12 had cadaver donors, 37 living related donors and 4 living non-related donors. Fifty-one patients had their first transplant, 1 with a second transplant and the last with a third kidney transplant. The post-transplant period was between 6 and 138 months with a median of 39 ± 27 months. Diabetes mellitus was indicated in 14 cases. Weight, arterial blood pressure, hemoglobin, hematocrit, leucocytes, platelets, cholesterol, triglycerides, low- and high-density lipoproteins and hepatic enzymes were similar. The median values for cyclosporine at baseline levels (C0) of Neoral and Zaven ME were 153 and 129.5, respectively, at the sixth month, with no statistical significance. The average values for cyclosporine 2 hr levels (C2) of Neoral and Zaven ME were 694.7 and 658.4, respectively, with no differences. The average of serum creatinine was 1.315 for Neoral and 1.38 for Zaven ME. No acute rejection was observed and two deaths occurred: one with acute idiopathic pancreatitis and the other with cardiomyopathy. In both cases medication was not the cause of death.
Conclusions: the study variables were not different between the cyclosporine formulations.

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