medwireNews: Secondary analysis of the VERTIS CV trial supports a significant protective effect of ertugliflozin on risk for heart failure (HF) in people with type 2 diabetes, despite the overall neutral outcome of the trial.
VERTIS CV is the only sodium-glucose cotransporter (SGLT)2 inhibitor cardiovascular outcomes trial so far to have produced a neutral result, with all others showing a reduced risk for a primary composite major adverse cardiovascular event endpoint with active treatment versus placebo.
By contrast, the effects of ertugliflozin on prespecified secondary HF outcomes “correspond to what has been reported for other members of the SGLT2 inhibitor class,” say Francesco Cosentino (Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden) and co-investigators.
During an average 3.5 years of follow-up, 2.5% of the 5499 trial participants taking ertugliflozin (5 or 15 mg/day) had a first HF hospitalization, compared with 3.6% of the 2747 taking placebo, giving a significant 30% reduced risk with ertugliflozin. The risk reduction was 29% for people taking the 5 mg dose and 32% for those taking the 15 mg dose.
There was also a 30% reduction in the risk for total (ie, first and recurrent) HF events, after accounting for prevalent HF and cardiovascular disease at baseline, the researchers report in Circulation.
They note that 23.7% of the trial population had HF at the point of enrollment, which is “similar to the proportion found in a typical diabetes clinical practice.”
The significant positive effect of ertugliflozin on HF outcomes occurred regardless of the presence of HF at baseline. Hospitalization for first HF occurred at rates of 5.4% versus 8.2% with ertugliflozin versus placebo in trial participants with prior HF, giving a risk reduction of 37%, and in a corresponding 1.7% and 2.1% of those without prior HF, giving a reduction of 21%.
The effect of ertugliflozin was also unaffected by whether people’s left ventricular ejection fraction was above or below 45%.
The researchers found the benefits of active treatment to be largely consistent across subgroups defined by participant clinical and treatment variables. However, ertugliflozin treatment seemed to offer particular benefit to people with an estimated glomerular filtration rate below 60 mL/min per 1.73 m2, those with albuminuria, and those on diuretics, especially loop diuretics.
These findings “complement emerging evidence suggesting greater benefit on HF events in those with impaired kidney function, and those taking diuretics,” conclude the researchers.
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