Oral Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2017

Severe hypoglycaemia, cardiovascular outcomes and death – the LEADER experience (#110)

Timothy Davis 1 , Bernard Zinman 2 , Steven P Marso 3 , Erik Christiansen 4 , Salvatore Calanna 4 , Søren Rasmussen 4 , John B Buse 5
  1. University of Western Australia, Fremantle, WA, Australia
  2. Lunenfeld–Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada
  3. Research Medical Center, Kansas City, MO, USA
  4. Novo Nordisk A/S, Søborg, Denmark
  5. University of North Carolina School of Medicine, Chapel Hill, NC, USA

In the LEADER cardiovascular outcomes trial (N=9340; NCT01179048), the risk of cardiovascular and hypoglycaemia events was reduced with liraglutide treatment versus placebo, when added to standard of care, in patients with type 2 diabetes and at high risk for cardiovascular disease.

This post hoc analysis examines the associations between severe hypoglycaemia and cardiovascular events and death in LEADER.

We analysed the time to first major adverse cardiovascular event (MACE; cardiovascular death, non-fatal myocardial infarction or non-fatal stroke), cardiovascular death and all-cause death among patients with/without severe hypoglycaemia, and adjusted for different periods of follow-up and randomised treatment.

During the trial, 267 patients experienced severe hypoglycaemia (liraglutide n=114, placebo n=153; rate ratio, 0.69; 95% CI: 0.51; 0.93). These patients were more likely than those without severe hypoglycaemia to experience MACE, CV death and all-cause death, with a considerably higher risk up to 60 days after the hypoglycaemic episode (Table) irrespective of treatment group. The protective effect of liraglutide on risk of MACE was unchanged when patients with severe hypoglycaemia were excluded from the analysis (patients with severe hypoglycaemia accounted for 5% of all MACE in LEADER).

Patients experiencing severe hypoglycaemia in LEADER were at greater risk of cardiovascular events and death, particularly early after the hypoglycaemic episode. Reducing severe hypoglycaemia remains a cornerstone of diabetes management.

 

591eaa726dd50-Table.jpg