The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial

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Authors: Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornøe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators

Publication: Diabetes Care

Year: 2018
Link: https://www.ncbi.nlm.nih.gov/pubmed/30072400

OBJECTIVE:

Diabetes-related foot ulcers (DFUs) and their sequelae result in large patient and societal burdens. Long-term data determining the efficacy of individual glucose-lowering agents on DFUs are lacking. Using existing data from the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, we conducted post hoc analyses assessing the impact of liraglutide versus placebo in people with type 2 diabetes and at high risk of cardiovascular (CV) events on the incidence of DFUs and their sequelae.

RESEARCH DESIGN AND METHODS:

The LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years. Information on DFUs was collected systematically during the trial, and DFU complications were assessed post hoc through reviewing case narratives.

RESULTS:

During a median of 3.8 years’ follow-up, similar proportions of patients reported at least one episode of DFU in the liraglutide and placebo groups (3.8% [176/4,668] versus 4.1% [191/4,672], respectively; hazard ratio [HR] 0.92 [95% CI 0.75, 1.13; P = 0.41]). Analysis of DFU-related complications demonstrated a significant reduction in amputations with liraglutide versus placebo (HR 0.65 [95% CI 0.45, 0.95; P = 0.03]). However, no differences were found for foot infections, involvement of underlying structures, or peripheral revascularization in the main analysis.

CONCLUSIONS:

Treatment with liraglutide in patients with type 2 diabetes and at high risk of CV events in the LEADER trial did not increase the risk of DFU events and was associated with a significantly lower risk of DFU-related amputations compared with placebo. This association, possibly due to chance, needs further investigation.

  • Listing ID: 6633
  • Author/s: Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornøe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators
  • Publication: Diabetes Care   
  • Year: 2018
  • Volume: 41
  • Issue: 10
  • Start Page: 2229