Mark A. Schnitzler

Incidence of BK with Tacrolimus Versus Cyclosporine and Impact of Preemptive Immunosuppression Reduction

Our purposes were to determine the incidence of BK viruria, viremia or nephropathy with tacrolimus (FK506) versus cyclosporine (CyA) and whether intensive monitoring and discontinuation of mycophenolate (MMF) or azathioprine (AZA), upon detection of BK viremia, could prevent BK nephropathy.

Incidence and Cost of New Onset Diabetes Mellitus Among U.S. Wait-Listed and Transplanted Renal Allograft Recipients

This study sought to determine 1) the incidence and costs of new onset diabetes mellitus (NODM) associated with maintenance immunosuppression regimens following renal transplantation and 2) whether the mode of dialysis pretransplant or the type of calcineurin inhibition used for maintenance immunosuppression affected either the incidence or cost of NODM. The study examined the United States Renal Data Systems clinical and financial records from 1994 to 1998 of all adult, first, single‐organ, renal transplantations in either 1996 or 1997 with adequate financial records. It used the second diagnosis of diabetes in previously nondiabetic patients to identify NODM. While NODM had an incidence of approximately 6% per year among wait‐listed dialysis patients, NODM over the first 2 years post‐transplant had an incidence of almost 18% and 30% among patients receiving cyclosporine and tacrolimus, respectively. By 2 years post‐transplant, Medicare paid an extra

Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients

21 500 per newly diabetic patient. We estimated the cost of diabetes attributable to maintenance immunosuppression regimens to be

OPTN/SRTR 2012 Annual Data Report: Pancreas: OPTN & SRTR Annual Data Report 2012

2025 and

Incidence and Predictors of Myocardial Infarction after Kidney Transplantation

3308 for each tacrolimus patient and

Racial Variation in Medical Outcomes among Living Kidney Donors

1137 and

Transplant Outcomes and Economic Costs Associated with Patient Noncompliance to Immunosuppression

1611 for each cyclosporine patient at 1 and 2 years post‐transplant, respectively.

Guidelines for the treatment and management of new-onset diabetes after transplantation.

Prophylaxis reduces cytomegalovirus (CMV) disease, but is associated with increased costs and risks for side effects, viral resistance and late onset CMV disease. Preemptive therapy avoids drug costs but requires frequent monitoring and may not prevent complications of asymptomatic CMV replication. Kidney transplant recipients at risk for CMV (D+/R−, D+/R+, D−/R+) were randomized to prophylaxis (valganciclovir 900 mg q.d. for 100 days, n = 49) or preemptive therapy (900 mg b.i.d. for 21 days, n = 49) for CMV DNAemia (CMV DNA level >2000 copies/mL in ≥ 1 whole blood specimens by quantitative PCR) assessed weekly for 16 weeks and at 5, 6, 9 and 12 months. More patients in the preemptive group, 29 (59%) than in the prophylaxis group, 14 (29%) developed CMV DNAemia, p = 0.004. Late onset of CMV DNAemia (>100 days after transplant) occurred in 11 (24%) randomized to prophylaxis, and none randomized to preemptive therapy. Symptomatic infection occurred in five patients, four (3 D+/R− and 1 D+/R+) in the prophylactic group and one (D+/R−) in the preemptive group. Peak CMV levels were highest in the D+/R− patients. Both strategies were effective in preventing symptomatic CMV. Overall costs were similar and insensitive to wide fluctuations in costs of either monitoring or drug.

Donor origin of BK virus in renal transplantation and role of HLA C7 in susceptibility to sustained BK viremia.

For most end‐stage renal disease patients, successful kidney transplant provides substantially longer survival and better quality of life than dialysis, and preemptive transplant is associated with better outcomes than transplants occurring after dialysis initiation. However, kidney transplant numbers in the us have not changed for a decade. Since 2004, the total number of candidates on the waiting list has increased annually. Median time to transplant for wait‐listed adult patients increased from 2.7 years in 1998 to 4.2 years in 2008. The discard rate of deceased donor kidneys has also increased, and the annual number of living donor transplants has decreased. The number of pediatric transplants peaked at 899 in 2005, and has remained steady at approximately 750 over the past 3 years; 40.9% of pediatric candidates undergo transplant within 1 year of wait‐listing. Graft survival continues to improve for both adult and pediatric recipients. Kidney transplant is one of the most cost‐effective surgical interventions; however, average reimbursement for recipients with primary Medicare coverage from transplant through 1 year posttransplant was comparable to the 1‐year cost of care for a dialysis patient. Rates of rehospitalization are high in the first year posttransplant; annual costs after the first year are lower.

Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys.

The risk and predictors of post-kidney transplantation myocardial infarction (PTMI) are not well described. Registry data collected by the United States Renal Data System were used to investigate retrospectively PTMI among adult first renal allograft recipients who received a transplant in 1995 to 2000 and had Medicare as the primary payer. PTMI events were ascertained from billing and death records, and participants were followed for up to 3 yr after transplant or until the end of observation (December 31, 2000). Extended Coxs hazards analysis was used to identify independent clinical correlates of PTMI (hazard ratio [HR]) and to examine PTMI as an outcomes predictor. Among 35,847 eligible participants, the cumulative incidence of PTMI was 4.3% (95% confidence interval [CI], 4.1 to 4.5%), 5.6% (95% CI, 5.3 to 5.8%), and 11.1% (95% CI, 10.7 to 11.5%) at 6, 12, and 36 mo, respectively. Risk factors for PTMI included older recipient age, pretransplantation comorbidities (diabetes, angina, peripheral vascular disease, and MI), transplantation from older donors and deceased donors, and delayed graft function. Women, blacks, Hispanics, and employed recipients experienced reduced risk. The hazard of PTMI rose after a diagnosis of posttransplantation diabetes (HR, 1.60; 95% CI, 1.35 to 1.88) and markedly increased after graft failure (HR, 2.78; 95% CI, 2.41 to 3.19). In separate analyses, PTMI predicted death-censored graft failure (HR, 1.89; 95% CI, 1.63 to 2.20) and strongly predicted death in a manner that declined with time after PTMI. Risk factors for PTMI include potentially modifiable posttransplantation complications. Because PTMI in turn predicts graft failure and death, reducing the risk for PTMI may improve outcomes after kidney transplantation.