NEW YORK (Reuters Health) – For patients with type-2 diabetes and worsening heart failure, treatment with sotagliflozin, a sodium-glucose cotransporter-1 (SGLT1) and SGLT2 inhibitor, increases the proportion of time patients are alive and out of the hospital, according to new data from the SOLOIST-WHF trial.
This finding is noteworthy, say the researchers, given that increased rates of re-hospitalization and death are significant components of disease burden in this patient population.
The SOLOIST-WHF trial was a randomized, double-blind, placebo-controlled trial conducted at more than 300 sites in 32 countries.
Participants included 1,222 adults with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure who were randomly assigned to treatment with 200 mg of sotagliflozin once daily (with a possible dose increase to 400 mg) or placebo.
The main results of the trial were published in The New England Journal of Medicine last year (https://bit.ly/3vz2J6d). They showed that treatment with sotagliflozin led to a 33% reduction in cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo.
This week in Annals of Internal Medicine, the researchers report results of a prespecified analysis comparing the patient-centered outcome of days alive outside the hospital (DAOH) between the two groups.
Similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%, P=0.30), but significantly fewer patients taking sotagliflozin were hospitalized more than once (16.3% vs. 22.1%, P=0.009), report Dr. Michael Szarek of the University of Colorado Anschutz Medical Campus, in Aurora, and colleagues.
During the study, there were 64 deaths in the sotagliflozin group and 76 in the placebo group. The DAOH rate was 3% higher in the sotagliflozin group than the placebo group (P=0.027). For every 100 days of follow-up, patients in the sotagliflozin were alive and out of hospital 2.9 days more than patients in the placebo group, the researchers report.
“Sotagliflozin increased DAOH, a metric that may provide an additional patient-centered outcome to capture the totality of disease burden. Future studies are needed to quantify the consequences of increasing DAOH in terms of health economics and patient quality of life,” the researchers conclude
The SOLOIST-WHF trial was funded by Sanofi at initiation and by Lexicon Pharmaceuticals at completion. Several authors have disclosed financial relationships with the companies.
SOURCE: https://bit.ly/3gIJLpx Annals of Internal Medicine, online June 21, 2021.