Heart failure benefits of sotagliflozin consistent in preserved ejection fraction
medwireNews: The protective effect of sotagliflozin in people with type 2 diabetes and heart failure extends to those who have preserved ejection fraction, shows a prespecified pooled analysis of SOLOIST-WHF and SCORED.
The analysis also revealed a statistically consistent benefit of sotagliflozin treatment in both men and women. There were more men than women in the trial, but the pooled analysis confirmed benefits for both sexes, including those with a preserved ejection fraction.
SOLOIST-WHF and SCORED included people with type 2 diabetes plus heart failure (shortly after an acute episode) and chronic kidney disease, respectively. Both trials had the same composite primary endpoint of death from cardiovascular causes, hospitalization for heart failure, and urgent visits for heart failure, and both reported a significant protective effect with sotagliflozin versus placebo.
In this pooled intention-to-treat analysis, which included nearly 12,000 trial participants, sotagliflozin and placebo were associated with primary outcome rates of 15.5 and 21.1 per 100 participants, respectively, reported investigator Deepak Bhatt (Brigham and Women’s Hospital, Boston, Massachusetts, USA).
This equated to 31 patient–years of treatment required to prevent one primary outcome event.
Looking at these rates according to ejection fraction revealed a consistent protective effect for all categories, Bhatt told attendees of the virtual American College of Cardiology 70th Annual Scientific Session.
Specifically, rates in people with an ejection fraction below 40% were 47.8 and 60.4 per 100 participants treated with sotagliflozin and placebo, respectively, giving 11 patient–years of treatment to avoid one event.
For people with a mid-range ejection fraction of at least 40% but less than 50%, the corresponding rates were 45.2 and 71.3 per 100 participants and 7 patient–years of treatment, and for those with preserved ejection fraction (≥50%) they were 37.5 versus 59.0 per 100 participants and 9 patient–years.
There was no statistically significant interaction between the effect of sotagliflozin and participants’ ejection fraction, whether assessed by category or as a continuous variable, Bhatt reported.
People without prior heart failure also benefitted, but to a lesser degree, with statistical significance only just attained, at rates of 5.2 versus 6.2 per 100 participants and 121 patient–years of treatment to prevent one event.
The majority of the treatment benefit in both trials came from a reduction in heart failure hospitalization and urgent visits, with the effect on cardiovascular death being nonsignificant. However, Bhatt noted that this attained statistical significance in a pooled on-treatment analysis, at a risk reduction of 23%, or 27% when restricted to participants with a history of heart failure.
He conceded that on-treatment analyses “in some respects show a best-case scenario,” but that the finding nevertheless “shows the potential for the drug to reduce [cardiovascular] death.”
The presenter added that this finding was in line with data from the medication class overall, and with the positive trend in the intention-to-treat analysis, which, he suggested, might have attained statistical significance “if only we had the funding to continue the trials to the full planned duration.”
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