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Abstract: TH-PO717

ESRD and Mortality after VA NEPHRON-D

Session Information

Category: Diabetes

  • 502 Diabetes Mellitus and Obesity: Clinical

Authors

  • Fried, Linda F., VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States
  • Huang, Yuan, Yale University, New Haven, Connecticut, United States
  • Zhang, Jane Hongyuan, VA CSP, Albuquerque, New Mexico, United States
  • Palevsky, Paul M., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
  • Johnson, Gary R, VA CSP, Albuquerque, New Mexico, United States
  • Seliger, Stephen L., University of Maryland School of Medicine, Baltimore, Maryland, United States
  • McCullough, Peter A., Baylor University Medical Center, Dallas, Texas, United States
  • Conner, Todd A, VA CSP, Albuquerque, New Mexico, United States
  • Brophy, Mary, VA Boston Healthcare System, Boston, Massachusetts, United States
  • Emanuele, Nicholas, Hines VA, Hines, Illinois, United States
Background

VA NEPHRON-D, a trial of ACEI+ARB vs. ARB alone in type 2 diabetes, eGFR 30-89.9 ml/min/1.73m2 and ACR ≥ 300mg/g, was stopped for safety; questions of benefit remained.

Methods

At the end of the study, participants were asked to join passive follow-up with electronic data abstraction through 9/30/14. ESRD was defined during study as eGFR < 15 or chronic dialysis; and during follow-up by USRDS linkage of ICD9 and CPT coding. AKI was a study safety event; during follow-up it was defined by ICD9 code or 50% rise in creatinine. All-cause mortality was obtained from VHA Vital Status File.

Results

Of the 1448 randomized, 895 (61.8%, 445 in the ARB alone and 450 in the ARB+ACEI) consented to follow-up. Over the entire study, 75 (10.4%) in the monotherapy arm developed ESRD and 157 (21.7%) died vs. 63 (8.7%) and 146 (20.2%) respectively in the ACEI + ARB arm, which was not statistically significant. There was a significant decline in eGFR slope over time, but the slope was similar in both treatment groups (p= 0.13); eGFR at start of study and end of followup was 59.0 and 38.2 in ARB alone vs. 57.6 and 37.1 in ACEI + ARB.
There was a significant AKI*treatment interaction for ESRD (p=0.013) (table). Combination therapy was associated with a decreased risk of ESRD in those without AKI (HR=0.61), but with a higher risk in those with AKI (HR=1.3). AKI predicted mortality, but there was no AKI*treatment interaction.

Conclusion

Overall, there was not an apparent long-term benefit or harm for combination therapy. Further research into the AKI * treatment interaction to determine whether it is unmasking a higher risk of ESRD or could be used to identify sub-populations that may benefit from combination therapy is needed

Number of ESRD events by AKI and Treatment
 no AKIAKI
ARB alone10.0%11.5%
ACEI + ARB5.8%19.1%

Funding

  • Veterans Affairs Support