Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange.

The evidence for conversion from brand name to generic equivalent cyclosporine is conflicting. Cyclosporine is a narrow therapeutic-range drug for which small variations in exposure may have severe clinical consequences for transplant patients. There is currently a lack of comparative outcome data relating to the pharmacokinetics of the reference formulation, Neoral, and generic formulations in transplant recipients. A major common concern is the potential inability to attain similar trough levels, an issue that can be easily corrected by ongoing therapeutic drug monitoring to ensure that the new steady state falls within an intended target range. Prospective clinical studies investigating the efficacy and safety of generic formulations in both de novo and long-term transplant patients are also awaited. Until further evidence is available on the conversion of transplant patients to or between generic formulations of cyclosporine, any transfer to a different cyclosporine formulation should be undertaken with close supervision. The best available information to date, however, does not support the frequently held but unsubstantiated belief that generic preparations of immunosuppressive drugs are not as effective as brand names or that conversion from brand to generic is associated with significant danger. This paper attempts to initiate a discussion of these issues.

Impact of recipient obesity on living donor kidney transplant outcomes: a single-center experience.

The number of overweight and obese patients undergoing renal transplantation has drastically increased in the last two decades. Studies on graft survival and complication rates of these obese patients have had conflicting results, with some reporting a significant risk and others reporting relatively good outcomes. We examined 1-year outcomes in obese and nonobese patients who underwent living donor transplants at our transplant program, a slightly different approach than prior studies of deceased donor transplants into patients with high body mass index (BMI). The mean serum creatinine clearance by the modified MDRD equation at the end of 1 year in the nonobese group was 58.9 mL/min whereas the mean creatinine clearance in the obese group was 48.9 mL/min (P = .09). The length of stay, incidence of delayed graft function, and 1-year graft survival did not differ between the obese and nonobese groups. The results of this single-center experience with living donor transplant into obese subjects suggest no differences in outcomes with regard to surgical or wound complications, delayed graft function, or serum creatinine at 1 year.

Measurement of fiber bundle volume in reprocessed dialyzers.

BACKGROUND: Fiber bundle volume (FBV) is an important determinant of dialyzer re-use efficiency. This measurement is performed after the dialyzer has been pressure cleaned and may underestimate the degree of clotted fibers a patient actually encounters while on dialysis. METHODS: Real-time online measure of FBV has been validated using an ultrasound dilution method and the Transonic HD01 monitor (Ithaca, NY, USA). Thirty-one stable chronic hemodialysis patients were studied during the first hour and then during the last 30 minutes of a typical dialysis session. Ultrasound velocity curves using a saline bolus were recorded by flow dilution sensors placed directly on the blood tubing using methods described previously. Blood volume within the dialyzer compartment was determined using a mathematical extrapolation of the measured transit time for a bolus of saline to pass through the dialyzer. These data were compared to FBV obtained using a Seartronics DRS4 (Fresinius, Walnut Creek, CA, USA) reprocessing machine both before and after the same dialysis session. RESULTS: At onset of treatment mean FBV by ultrasound was 100.0 +/- 2.7 ml and was unchanged at the end of the session at 100.0 +/- 3.1 ml (p = 0.49). Before a dialysis session, mean FBV measured on the DRS4 reprocessing machine was 123.5 +/- 2.1 ml and was unchanged following cleaning after dialysis at 121.7 +/- 2.0 ml (p = 0.20). The correlation coefficient between methods was 0.78. CONCLUSIONS: FBV did not change during a dialysis session using an online real-time measure. The results of this study do not support concerns that hemodialysis patients may experience considerably less efficient dialysis than standard FBV determination would suggest due to undetected clotting.