Kidney Week

Abstract: FR-PO668

Safety of Liraglutide versus Placebo in Patients with T2D and CKD in the LEADER Trial

Session Information

• Diabetic and Obesity Induced Kidney Disease - Clinical - II
  November 03, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Diabetes

• 502 Diabetes Mellitus and Obesity: Clinical

Authors

• Mann, Johannes F., KfH Kidney Center, Munich, Germany

Johannes F. Mann,

• Fonseca, Vivian A., Tulane University Medical Center, New Orleans, Louisiana, United States

Vivian A. Fonseca,

• Mosenzon, Ofri, Hadassah Hebrew University Hospital, Jerusalem, Israel

Ofri Mosenzon,

• Raz, Itamar, Hadassah Hebrew University Hospital, Jerusalem, Israel

Itamar Raz,

• Frimer-Larsen, Helle, Novo Nordisk A/S, Soborg, Denmark

Helle Frimer-Larsen,

• Von Scholten, Bernt Johan, Novo Nordisk A/S, Soborg, Denmark

Bernt Johan Von Scholten,

• Idorn, Thomas, Novo Nordisk A/S, Soborg, Denmark

Thomas Idorn,

• Poulter, Neil, Imperial College, London, United Kingdom

Neil Poulter,

Group or Team Name

• On behalf of LEADER Trial Steering Committee and Investigators

Background

We assessed the safety of liraglutide vs placebo (PBO) in patients with chronic kidney disease (CKD) in the LEADER trial.

Methods

LEADER was a randomized, double-blind, multicenter, placebo-controlled cardiovascular (CV) outcome trial assessing CV and long-term safety of liraglutide up to 1.8mg/day vs PBO plus standard of care for 3.5-5 years in 9340 type 2 diabetes (T2D) patients at high risk for CV disease. We stratified participants according to baseline estimated glomerular filtration rate (eGFR) <60 (with CKD) or ≥60ml/min/1.73m² (without CKD) and analyzed: serious adverse events (SAEs), SAEs leading to discontinuation, acute renal failure, nausea leading to discontinuation, acute gallstone disease, severe hypoglycemia and foot ulcers.

Results

Mean eGFR in patients with (n=2158) or without CKD (n=7158) was 45.7±10.9 and 90.8±21.6mL/min/1.73m², respectively. There was no increased risk of SAEs or SAEs leading to discontinuation with liraglutide vs PBO in those with and without CKD (Fig); and no conclusive risk of acute renal failure in those with CKD (hazard ratio [HR] 0.82, confidence interval [CI] 0.61;1.10) or without CKD (HR 1.26, CI 0.88;1.79) with liraglutide vs PBO. There was no difference in the risk of nausea leading to discontinuation or acute gallstone disease in patients with and without CKD. Severe hypoglycemia risk was significantly reduced with liraglutide by 37% (with CKD, HR 0.63, CI 0.43;0.91) and non-significantly reduced by 19% (without CKD, HR 0.81, CI 0.59;1.12). Diabetic foot ulcer risk was not increased with liraglutide in those with and without CKD (Fig).

Conclusion

In LEADER, liraglutide was as well tolerated in patients with CKD as in those without CKD.

Funding

• Commercial Support – Novo Nordisk A/S