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Patients with a preserved ejection fraction saw a significant reduction in risk for cardiovascular-related adverse events and mortality.
A pooled analysis of the SCORED and SOLOIST-WHF trails revealed that the SGLT1/2 inhibitor sotagliflozin was robustly effective in reducing cardiovascular events in patients with diabetes and all forms of heart failure. This beneficial effect was particularly noted for individuals with a preserved ejection fraction.
The results of the analysis were presented by Deepak Bhatt, MD, MPH, Brigham and Women’s Hospital, at the American College of Cardiology (ACC) Annual Scientific Session.
Bhatt’s team evaluated the combined data from both trials to determine the drug’s effect on their primary end points, defined in both as total number of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure. This effect was assessed for baseline ejection fraction.
Investigators from SCORED evaluated sotagliflozin among patients with both diabetes and chronic kidney failure (n = 10,584) who were randomized to drug or placebo. Median follow-up for these patients was 16.0 months.
As previously reported in The New England Journal of Medicine, sotagliflozin with associated with fewer combined instances of the primary outcomes compared with placebo (HR, 0.74; 95% CI, 0.63-0.88; P = .0004). Thus, cardiovascular events were reduced by 26% with sotagliflozin as compared with placebo.
In SOLOIST-WHF, patients with diabetes and worsening heart failure (n = 1222) were randomized 1:1 to placebo or sotagliflozin, with a median follow-up duration of 9.0 months.
Patients in the sotagliflozin cohort experienced fewer instances of the primary outcome versus placebo (HR, 0.67; 95% CI, 0.52-0.85; P = .0009). And so, treatment with the drug was linked to a 33% reduction in cardiovascular death, hospitalizations, and urgent visits compared with placebo.
Across the entire 11,784 patient population, Bhatt and colleagues found that the dual SGLT1 and 2 inhibior significantly reduced cardiovascular adverse outcomes regardless of baseline ejection fraction (HR, 0.72; 95% CI, 0.63-0.82; P = .000002).
The team also assessed a subpopulation of patients (n = 4500) with a history of heart failure. All patients had various levels of ejection fraction.
Among those with an ejection fraction ≤40%, sotagliflozin-related risk reduction was -22% in both the heart failure subgroup and entire pooled cohort. As for those with an ejection fraction of 40%-50%, risk was reduced by 43% for the heart failure group and 39% in the entire cohort.
And finally, for patients with heart failure with a preserved ejection fraction (≥50%), the drug reduced risk by 33% and 30% in the heart failure cohort and full cohort, respectively.
The investigators noted that all results were found to be statistically significant.
“We saw a significant reduction in the primary endpoint irrespective of patients’ ejection fraction at study entry,” Bhatt said in a statement. “The magnitude of the benefit in patients with HFpEF was surprising. Sotagliflozin offers a meaningful, incremental advance in improving outcomes for this challenging group of patients.”
Nevertheless, further investigations among non-diabetic patients are needed, the investigators noted.
Watch Deepak Bhatt, MD, MPH, speak with HCPLive® about the pooled analysis of the SOLOIST-WHF and SCORED trials and its implications:
The study, “Benefits Of Sodium Glucose Co-transporter-1/2 Inhibition With Sotagliflozin Across The Full Spectrum Of Ejection Fraction, Including Heart Failure With Preserved Ejection Fraction,” was presented at ACC 2021.