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Abstract: FR-PO462

Increasing Baseline Albuminuria Is Associated with a Continuously Increased Risk of Cardiovascular (CV) and Renal Outcomes in the LEADER Trial

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical


  • Mosenzon, Ofri, Hadassah Hebrew University Hospital, Jerusalem, Israel
  • Bain, Stephen, Institute of Life Science, Swansea University, Swansea, United Kingdom
  • Persson, Frederik, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Lambers Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands
  • Mann, Johannes F., KfH Kidney Center, and Friedrich Alexander University of Erlangen, Munich, Germany
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Idorn, Thomas, Novo Nordisk A/S, Soborg, Denmark
  • Rasmussen, Soren, Novo Nordisk A/S, Soborg, Denmark
  • Von Scholten, Bernt Johan, Novo Nordisk A/S, Soborg, Denmark
  • Raz, Itamar, Hadassah Hebrew University Hospital, Jerusalem, Israel

Group or Team Name

  • The LEADER Publication Committee on behalf of the LEADER Trial Investigators

Albuminuria is a known risk factor for CV disease, but the lower limit from which it is a risk factor is not well defined.


We assessed CV and renal outcomes by increasing levels of baseline urinary albumin-to-creatinine ratio (UACR) in the LEADER trial. LEADER was a randomized, double-blind, placebo-controlled CV outcomes trial of liraglutide up to 1.8 mg/day vs placebo added to standard care for 3.5–5 years in 9340 patients with type 2 diabetes and high risk for CV disease. We analyzed the risk of major adverse CV events (MACE), expanded MACE, all-cause death, and adjudicated renal events (doubling of serum creatinine and estimated glomerular filtration rate ≤45 ml/min/1.73 m2; the need for continuous renal-replacement therapy; or death from renal disease) by baseline UACR irrespective of treatment group; UACR < lower limit of quantification (LLoQ) (G0; n=1598), 0 to <15 mg/g (G1; n=2905), 15 to <30 mg/g (G2; n=1196), 30 to <100 mg/g (G3; n=1609), 100 to <300 mg/g (G4; n=845), and ≥300 mg/g (G5; n=960).


The risk of MACE, expanded MACE, all-cause death and renal events increased with increasing baseline UACR (Figure), statistically significant for all subgroups with UACR ≥30 mg/g compared to G0. Interestingly, in patients at the higher part of the normoalbuminuric range (G2), a trend towards increased risk for CV events and all-cause death was observed.


In LEADER, baseline UACR≥30 mg/g was associated with increased risk of death, and CV and renal events, emphasizing the importance of albuminuria as a modifiable risk factor.


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