In patients with type 2 diabetes recently hospitalized for worsening heart failure, treatment with sotagliflozin was associated with increased days alive and out of the hospital compared to placebo, an industry-funded study found.
Researchers looked at whether the sodium-glucose cotransporter-1 and cotransporter-2 inhibitor increased the prespecified efficacy outcome of days alive and out of the hospital in the double-blinded SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial. Participants with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure at 306 sites in 32 counties received either 200 mg of sotagliflozin once daily (with a goal of a dose increase to 400 mg) or matching placebo. The study was sponsored by Sanofi at initiation and Lexicon Pharmaceuticals at completion. Results were published online on June 22 by Annals of Internal Medicine.
The study included 1,222 patients randomized to receive sotagliflozin (n=608; median age, 69 years; 32.6% women) or placebo (n=614; median age, 70 years; 34.9% women). During a median of nine months of follow-up, similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%, respectively); however, fewer patients in the sotagliflozin group were hospitalized more than once (16.3% vs. 22.1%). There were 64 and 76 deaths in the sotagliflozin and placebo groups, respectively. Days alive and out of the hospital in the sotagliflozin group were 3% higher than in the placebo group (rate ratio [RR], 1.03 [95% CI, 1.00 to 1.06]; P=0.027). The difference was mainly driven by a reduction in days dead (RR, 0.71 [95% CI, 0.52 to 0.99]; P=0.041) rather than by the rate of days hospitalized. For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital for 2.9 more days than those in the placebo group (91.8 vs. 88.9 d), reflecting a 2.6-day difference in days dead (6.3 vs. 8.9 d) and a 0.3-day difference in days in the hospital (1.9 vs. 2.2 d).
Limitations of the study include the fact that other than heart failure, the primary reason for each hospitalization was unspecified, the authors noted. They added that study enrollment and duration of follow-up were cut short due to loss of sponsor funding during the COVID-19 pandemic.
“Future research in this area could focus on either different patient populations or subgroups within completed studies with higher rates of hospitalization, to gain more clarity on how reducing the risk for incident hospitalization translates to cumulative days in the hospital,” the authors wrote. “It would also be important to quantify the consequences of increasing [days alive and out of the hospital] in terms of health economics and patient quality of life.”