SOLOIST-WHF: Sotagliflozin beneficial when started shortly after acute heart failure episode
medwireNews: Starting sotagliflozin in people with type 2 diabetes during or shortly after hospitalization for heart failure (HF) significantly reduces their risk for further cardiovascular (CV) events over the following months, show the results of the SOLOIST-WHF trial.
Despite the early closure of the trial due to loss of funding, the investigators found a significant reduction in the primary endpoint of CV deaths and hospitalizations and urgent visits for HF during a median 9.0 months of follow-up.
The rate of primary endpoint events was 51.0 per 100 patient–years among the 608 study participants randomly assigned to receive sotagliflozin, compared with 76.3 per 100 patient–years among the 614 given placebo, equating to a significant 33% relative difference favoring sotagliflozin treatment.
The study participants were a median age of 70 years, around two-thirds were men, and the vast majority were White. They were recruited if they were hospitalized for signs and symptoms of HF and received intravenous diuretic treatment during their stay. The participants began taking their study medications either when in hospital or within 3 days after discharge, with sotagliflozin given initially at 200 mg/day and increased to 400 mg/day if side effects allowed.
The benefits of sotagliflozin treatment were consistent regardless of whether treatment started before or after hospital discharge, and were evident within 1 month, show the findings published in The New England Journal of Medicine to coincide with their presentation at the virtual AHA Scientific Sessions 2020.
“Early initiation of therapy represents an important opportunity to improve outcomes, as indicated by the high rate of primary end-point events at 90 days after randomization among the patients receiving placebo,” write Deepak Bhatt (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and co-investigators.
The positive effect of active treatment was also observed across geographic regions (Europe, North or Latin America, or rest of the world), regardless of age and sex, whether left ventricular ejection fraction was below 50% or preserved, and whether or not renal function was below 60 mL/min per 1.73 m2.
For secondary endpoints, the rate of hospitalizations and urgent visits for HF was significantly reduced with sotagliflozin versus placebo, at 40.4 versus 63.9 per 100 person–years, but that of CV deaths was not, at 10.6 versus 12.5 per 100 person–years. The statistical significance of other secondary endpoints was not tested, because of the prespecified hierarchical testing plan, but the team notes that the early termination of the trial limited the statistical power to detect differences in secondary endpoints.
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