- LEADER trial: liraglutide reduced major adverse cardiovascular events (MACE), nephropathy, and mortality vs placebo, without increased heart failure (HF) hospitalizations and regardless of baseline HF status.
Why this matters
- Effects of glucose-lowering therapies in type 2 diabetes (T2D) on HF outcomes vary.
- In multinational, double-blind, LEADER trial, 9340 patients with T2D and high cardiovascular risk were randomly assigned to liraglutide or placebo plus standard care and followed for 3.5-5 years.
- At baseline, 18% had New York Heart Association (NYHA) functional class I-III HF history.
- Funding: Novo Nordisk.
- No significant interaction (HRs; 95% CIs) between liraglutide vs placebo and HF history for:
- With HF history: 0.81 (0.65-1.02).
- Without: 0.88 (0.78-1.00; Pinteraction=.53).
- All-cause death:
- With HF history: 0.89 (0.70-1.14).
- Without: 0.83 (0.70-0.97; Pinteraction=.63).
- No HF hospitalization increase with liraglutide:
- With HF history: 0.98 (0.75-1.28).
- Without: 0.78 (0.61-1.00; Pinteraction=.22).
- Risk for nephropathy with liraglutide vs placebo:
- With HF history: 0.77 (0.51-1.18).
- Without: 0.78 (0.66-0.93).
- HF etiology, biomarker information not collected.
- Not all endpoints were prespecified.
- Not powered for all subgroup analyses.
- Possible medication differences between groups.
- May not apply to lower-risk populations, or NYHA class IV.