SGLT2i reduces HF hospitalizations in T2DM patients with ASCVD
Efficacy of ertugliflozin on heart failure-related events in patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular disease: Results of the VERTIS CV trial
Presented at the ESC congress 2020 by: Francesco Cosentino, MD, PhD (Stockholm, Sweden)
Introduction and methods
Patients with T2DM have an increased risk for heart failure (HF). Several clinical outcome trials have shown that SGLT2 inhibitors reduce the risk of hospitalization for HF (HHF) in T2DM patients.
The VERTIS CV trial was a multicenter, randomized, double-blind, placebo-controlled, event-driven trial in T2DM patients with atherosclerotic CVD (ASCVD). A total of 8246 patients were randomized in a 1:1:1 ratio to receive either ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo. The primary endpoint was time to first occurrence of major adverse CV events, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Previously presented results showed that ertugliflozin was non-inferior to placebo on the primary endpoint (P<0.001 for non-inferiority). The objective of the current analysis was to perform pre-specified secondary analyses of HF-related outcomes in the VERTIS CV trial, comparing the effect of ertugliflozin to placebo on time to first HFF event. Furthermore, additional analyses assessed the effect of ertugliflozin on total HHF (first and recurrent events) and total HHF/CV death events. Subgroup analyses were based on history of HF, pre-trial ejection fraction and other factors, including clinical characteristics and medication use.
- Time to first HHF was 30% lower in the ertugliflozin group (pooled doses), compared to the placebo group (HR 0.70, 95%CI 0.54-0.90, P=0.06). Results with the individual doses of ertugliflozin (5 mg and 15 mg) were consistent with the pooled analysis.
- The effect of ertugliflozin was not modified by history of HF (P for interaction=0.40) nor by pre-trial ejection fraction (P for interaction=0.15).
- The effect of ertugliflozin, compared to placebo, was significantly greater in patients with baseline eGFR <60 mL/min/1.73 m², in patients with albuminuria and in those taking diuretics.
- Ertugliflozin significantly reduced total HHF (RR 0.70, 95%CI 0.56-0.87, P=0.001) and total HHF/CV deaths (RR 0.83, 95%CI 0.72-0.96, P=0.011), compared to placebo.
These pre-specified secondary analyses of HF-related outcomes in VERTIS CV showed that ertugliflozin reduced time to first HHF, and total HHF events and total HHF/CV death events in patients with T2DM and ASCVD.
-Our reporting is based on the information provided at the ESC congress -