Ertugliflozin may reduce total heart failure events by 34% and serious events by 38% in patients with type 2 diabetes and atherosclerotic cardiovascular disease, according to a recent study. 

In the multicenter, randomized, double-blind, phase III VERTIS CV trial, published in the European Journal of Heart Failure, investigators examined the impact of ertugliflozin on heart failure (HF) outcomes in patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD). This post hoc analysis evaluated both adjudicated hospitalizations for HF (HHF) and broader investigator-reported HF adverse events (AEs) and serious adverse events (SAEs).

They assigned 8,238 participants to receive ertugliflozin (5 mg or 15 mg) or placebo, with a mean follow-up of 3.5 years. HF events were identified using the standardized Medical Dictionary for Regulatory Activities query "cardiac failure," which included terms such as "pulmonary edema," "cardiac failure, congestive," and "left ventricular failure." Peripheral edema, orthopnea, and dyspnea were assessed separately. Analyses used Cox proportional hazards models for first HF events and Andersen–Gill models for total events.

Ertugliflozin significantly reduced the risk of first HF AEs by 31% compared with placebo (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.57–0.84, P < .001). The total HF AE rate also declined by 34% (HR = 0.66, 95% CI = 0.57–0.78, P < .001). Similar reductions were observed for HF SAEs, with a 34% decrease in first events (HR = 0.66, 95% CI = 0.52–0.84, P < .001) and a 38% decline in total events (HR = 0.62, 95% CI = 0.51–0.76, P < .001). Additionally, peripheral edema AEs were reduced by 42% (HR = 0.58, 95% CI = 0.45–0.74, P < .001). However, no significant reduction was seen in orthopnea/dyspnea (HR = 0.80, 95% CI = 0.57–1.12, P = .199). The results were constrained by the retrospective design of the analyses.

These findings confirmed ertugliflozin's 30% reduction in adjudicated HHF and demonstrated similar reductions in less severe HF events as identified through investigator-reported outcomes. The results provided evidence for incorporating both investigator-reported and adjudication-confirmed HF events to comprehensively assess treatment effects.

Full disclosures can be found in the published study.