No Increased Risk of Heart Failure Hospitalization or Major Cardiovascular Events Observed With Liraglutide in Patients With or Without a History of New York Heart Association Class I Heart Failure: Results From the LEADER Trial

Abstract

BACKGROUND: Some type 2 diabetes (T2D) therapies are associated with an increased risk of heart failure (HF).1 In the LEADER trial (NCT01179048), liraglutide significantly reduced the risk of major adverse cardiovascular (CV) events (MACE) by 13% vs placebo (PBO) when added to standard care in people with T2D and high CV risk.2 Here, we report post hoc analyses conducted to assess the risk of CV events, including HF hospitalization, in LEADER participants with or without a history of NYHA II-III HF.

METHODS: In LEADER, 9,340 patients with T2D and high CV risk were randomized 1:1 to add liraglutide or PBO to standard care, and followed for 3.5-5 years. Chronic NYHA IV HF was an exclusion criterion.

RESULTS: At baseline, 18% of patients in both treatment arms had a history of HF (NYHA I-III); 14% had a history of NYHA II-III HF. Overall, fewer patients were hospitalized for HF with liraglutide vs PBO during the trial (hazard ratio [95% confidence interval]: 0.87 [0.73-1.05], p=0.14; Table). There was no interaction between treatment and history of NYHA II-III HF for the risk of the primary CV endpoint, an expanded CV endpoint or HF hospitalization (Table).

CONCLUSION: Non-significant reductions in the risks of HF hospitalization and MACE were observed with liraglutide vs PBO in LEADER participants with a history of NYHA II-III HF. Fewer patients experienced these events with liraglutide vs PBO, regardless of baseline NYHA II-III HF status.

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