New onset diabetes is a major complication after kidney transplantation. However, the incidence, risk factors and clinical relevance of post-transplant diabetes mellitus (PTDM) vary among reports from single-center observational studies and clinical trials. Using data from the United Renal Data System we identified 11 659 Medicare beneficiaries who received their first kidney transplant in 1996-2000. The cumulative incidence of PTDM was 9.1% (95% confidence interval = 8.6-9.7%), 16.0% (15.3-16.7%), and 24.0% (23.1-24.9%) at 3, 12, and 36 months post-transplant, respectively. Using Cox's proportional hazards analysis, risk factors for PTDM included age, African American race (relative risk = 1.68, range: 1.52-1.85, p < 0.0001), Hispanic ethnicity (1.35, range: 1.19-1.54, p < 0.0001), male donor (1.12, range: 1.03-1.21, p = 0.0090), increasing HLA mismatches, hepatitis C infection (1.33, range: 1.15-1.55, p < 0.0001), body mass index ‡30 kg/m 2 (1.73, range: 1.57-1.90, p < 0.0001), and the use of tacrolimus as the initial maintenance immunosuppressive medication (1.53, range: 1.29-1.81, p < 0.0001). Factors that reduced the risk for PTDM included the use of mycophenolate mofetil, azathioprine, younger recipient age, glomerulonephritis as a cause of kidney failure, and a college education. As a time-dependent covariate in Cox analyses that also included multiple other risk factors, PTDM was associated with increased graft failure (1.63, 1.46-1.84, p < 0.0001), deathcensored graft failure (1.46, 1.25-1.70, p < 0.0001), and mortality (1.87, 1.60-2.18, p < 0.0001). We conclude that high incidences of PTDM are associated with the type of initial maintenance immunosuppression, race, ethnicity, obesity and hepatitis C infection. It is a strong, independent predictor of graft failure and mortality. Efforts should be made to minimize the risk of this important complication.

The rates for most malignancies are higher after kidney transplantation compared with the general population. Cancer should continue to be a major focus of prevention in kidney transplantation.

Moderate to severe cognitive impairment is common and undiagnosed in hemodialysis patients. Further studies are needed to determine whether dialysis exacerbates the cognitive impairment attributable to underlying disease. Cognitive testing in hemodialysis patients before dialysis initiation and periodically may be warranted.

We agree entirely with the comments of Dr Schnitzler, and reiterate that these results do not prove cause and effect. Certainly, the results in Table 3 of our manuscript do not prove that post-transplant diabetes mellitus (PTDM) causes graft failure, death-censored graft failure, or death (1). It is quite possible that PTDM is associated with worse outcomes because it is also associated with some other unmeasured factor(s) that cause both PTDM and worse outcomes. Acute rejection and its treatment with corticosteroids, for example, could cause both PTDM and worse outcomes.The purpose of this analysis was to determine whether the association between PTDM and graft failure was statistically independent of all the characteristics that were themselves associated with PTDM. We were not trying to determine whether tacrolimus was an independent predictor of outcomes. In fact, we believe that attempting to infer causal relationships between immunosuppressive agents and outcomes using registry data is particularly hazardous, as the choice of immunosuppressive agents is often made to mitigate risks, and after transplantation these agents are often changed as risk changes.Nevertheless, we believe that the relationship between tacrolimus and lower graft failure rates was not greatly mitigated by the association between tacrolimus and PTDM, which in turn was associated with a higher risk for graft failure. Indeed, the relative risk for graft failure associated with tacrolimus, adjusting for the effects of PTDM, was 0.70 (95% confidence interval 0.59-0.83, p < 0.0001), which was virtually identical to the relative risk of tacrolimus alone [not adjusting for PTDM, 0.72 (0.61-0.86, p < 0.0002)]. This was also true for both death-censored graft failure and death (data not shown). The other covariates in Table 3 that showed an association with PTDM also remained relatively unchanged when removing PTDM from the analysis (data not shown).Aside from all of these considerations and caveats, we believe that the data support our conclusions that (1) there is a high incidence of PTDM after kidney transplantation, (2) several patient characteristics (and type of immunosuppressive agents used initially) are associated with PTDM, and (3) PTDM is associated with poor outcomes. Further studies are certainly warranted.

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The long (2-day) interdialytic interval is a time of heightened risk among patients receiving hemodialysis. (Funded by the National Institutes of Health.).

The United States Renal Data System (USRDS) began in 1989 through US Congressional authorization under National Institutes of Health competitive contracting. Its history includes five contract periods, two of 5 years, two of 7.5 years, and the fifth, awarded in February 2014, of 5 years. Over these 25 years, USRDS reporting transitioned from basic incidence and prevalence of end-stage renal disease (ESRD), modalities, and overall survival, as well as focused special studies on dialysis, in the first two contract periods to a comprehensive assessment of aspects of care that affect morbidity and mortality in the second two periods. Beginning in 1999, the Minneapolis Medical Research Foundation investigative team transformed the USRDS into a total care reporting system including disease severity, hospitalizations, pediatric populations, prescription drug use, and chronic kidney disease and the transition to ESRD. Areas of focus included issues related to death rates in the first 4 months of treatment, sudden cardiac death, ischemic and valvular heart disease, congestive heart failure, atrial fibrillation, and infectious complications (particularly related to dialysis catheters) in hemodialysis and peritoneal dialysis patients; the burden of congestive heart failure and infectious complications in pediatric dialysis and transplant populations; and morbidity and access to care. The team documented a plateau and decline in incidence rates, a 28% decline in death rates since 2001, and changes under the 2011 Prospective Payment System with expanded bundled payments for each dialysis treatment. The team reported on Bayesian methods to calculate mortality ratios, which reduce the challenges of traditional methods, and introduced objectives under the Health People 2010 and 2020 national health care goals for kidney disease.

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