Author Interview: Barry I. Freedman, M.D.
Glycated Albumin and Risk of Death and Hospitalizations in Diabetic Dialysis Patients.

Freedman BI, Andries L, Shihabi ZK, Rocco MV, Byers JR, Cardona CY, Pickard MA, Henderson DL, Sadler MV, Courchene LM, Jordan JR, Balderston SS, Graham AD, Mauck VL, Russell GB, Bleyer AJ.
Clin J Am Soc Nephrol. 2011 May 19.

1. What are the main findings of the study? 

A longitudinal study sponsored by Asahi Kasei Pharma Corporation (Tokyo, Japan) assessed the impact of two assays of long-term glycemic control on important clinical outcomes in 444 dialysis patients with diabetes mellitus at Wake Forest School of Medicine out-patient dialysis facilities. The HbA1c assay was not predictive of the risk for death or hospitalization in this study. In contrast, the glycated albumin (GA) assay was significantly associated with both risk of death and hospitalizations in diabetic dialysis patients.

2. Were any of the findings unexpected?

Accurate HbA1c assay results are dependent on normal red blood cell lifespan. Unfortunately, red blood cell survival is reduced in patients with renal failure and this phenomenon reduces the utility of the HbA1c test in patients with advanced nephropathy or on dialysis. The GA assay has now proven to be the first long-term glycemic control assay that is significantly associated with patient survival and hospitalizations in diabetic patients performing dialysis.

3.   What should clinicians and patients take away from this study?

We suggest that the GA assay be considered in patients with diabetes mellitus on dialysis to accurately monitor recent blood sugar control.  The GA assay is currently available in Japan, China and South Korea; it is currently under evaluation by the FDA for use in the United States. 

4.   What recommendations do you have for nephrology health care providers as a result of your study?

Until the GA assay is available in the U.S. and elsewhere, we suggest that clinicians base diabetes treatment on the results of frequent daily blood sugar measurements (not on the HbA1c assay) in patients who are on dialysis. Several large studies demonstrate the lack of utility of the HbA1c assay in patients with diabetes and end-stage renal disease.

Barry I. Freedman, M.D.
John H. Felts III Professor and Chief, Section on Nephrology
Professor of Urology
Wake Forest School of Medicine
Medical Center Boulevard
Winston-Salem, NC 27157-1053

Glycated Albumin and Risk of Death and Hospitalizations in Diabetic Dialysis Patients.
Freedman BI, Andries L, Shihabi ZK, Rocco MV, Byers JR, Cardona CY, Pickard MA, Henderson DL, Sadler MV, Courchene LM, Jordan JR, Balderston SS, Graham AD, Mauck VL, Russell GB, Bleyer AJ.
Clin J Am Soc Nephrol. 2011 May 19.

Abstract
Summary Background and objectives Relative to hemoglobin (Hb) A(1c), glycated albumin (GA) more accurately reflects glycemic control in patients with diabetes mellitus and ESRD.

We determined the association between GA, HbA(1c), and glucose levels with survival and hospitalizations in diabetic dialysis patients. Design, setting, participants, & measurements Quarterly GA levels were measured for up to 2.33 years in 444 prevalent patients with diabetes and ESRD.

Proportional hazard time-dependent covariate models were computed with adjustment for demographic characteristics, comorbidities, and laboratory variables. Similar analyses were performed for available HbA(1c) and monthly random serum glucose determinations.

Results The participants were 53% male, 54% African American, 43% Caucasian, 90% on hemodialysis, with a mean (SD) age of 62 (12) years and median follow-up duration of 2.25 years. GA and HbA(1c) a mean ± SD of 21.5% ± 6.0%, median 20.4% and a mean ± SD of 6.9% ± 6.6%, median 1.6%, respectively.

There were 156 deaths during the observation period. In best-fit models, predictors of death included increasing GA, increasing age, presence of peripheral vascular disease, decreasing serum albumin, and decreasing hemoglobin concentrations. HbA(1c) and random serum glucose concentrations were not predictive of survival.

Increasing GA levels were associated with hospitalization in the 17 days after measurement, whereas HbA(1c) was not.

Conclusions In contrast to the HbA(1c) and random serum glucose values, GA accurately predicts the risk of death and hospitalizations in patients with diabetes mellitus and ESRD.

The GA assay should be considered by clinicians who care for patients with diabetes on dialysis.

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