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About 8 months away from the agent’s PDUFA date, data from a post-hoc analysis of SOLOIST-WHF is providing insight into the effects of sotagliflozin on first and subsequent heart failure-related events among people admitted for worsening heart failure.
A dual SGLT1/2 inhibitor, results of the study, which were presented at the Heart Failure Society of America (HFSA) 2022 annual scientific meeting, suggest use of sotagliflozin could reduce the relative risk of the study’s primary composite endpoint by a third compared to placebo therapy.
“In conclusion, in patients hospitalized for an episode of worsening heart failure, sotagliflozin was relatively well-tolerated and significantly reduced the primary endpoint of cardiovascular death, hospitalization for heart failures and urgent visits for heart failure by 33%,” said Bertram Pitt, MD, professor of medicine emeritus at the University of Michigan School of Medicine, during his presentation at HFSA 2022. “Patients treated with sotagliflozin experienced fewer single as well as multiple heart failure events. Thus, we conclude that sotagliflozin alters the trajectory of patients hospitalized for worsening heart failure.”
The revelations of the cardiometabolic benefits of SLGT2 inhibitors had major impact on the outlook for sotagliflozin. Once examined for the treatment of type 1 diabetes, renewed optimism surrounded the agent and the phase 3 program in heart failure added to the growing optimism. Originally presented at ESC Congress 2021, SOLOIST-WHF and SCORED provided evidence in support of sotagliflozin’s effect on reducing adverse heart failure outcomes. More recently, a multitude of analyses have further detailed the apparent benefits on cardiometabolic health, including renal endpoints. The current post-hoc analysis was designed with the intent of exploring the impact of sotagliflozin on outcomes among patients experiencing a single or multiple heart failure-related events during the trial.
Initial analyses indicated, of the 608 patients randomized to sotagliflozin in the trial, 14.5% experienced 1 primary endpoint event, 4.9% experienced 2 primary endpoint events, and 3.9% experienced 3 or more primary endpoint events. Of the 614 included in the placebo arm, 17.9% experienced 1 primary endpoint event, 8.0% experienced 2 primary endpoint events, and 5.7% experienced 3 or more primary endpoint events. Based on these results investigators determined the odds ratio for experiencing an eventwith sotagliflozin compared to placebo was 0.66 (95% CI, 0.51-0.84; P <.001).
With an interest in learning more about the totality of sotagliflozin data and how it might inform sotagliflozin’s role in care, if approved by the US Food and Drug Administration, Practical Cardiology reached out to Deepak Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, who served as the principal investigator of both the SOLOIST-WHF and SCORED trials. That conversation can be found in the video below.
This study, “Sotagliflozin, A Dual SGLT1 And SGLT2 Inhibitor, Reduces First And Subsequent Heart Failure-related Events In Patients Admitted For Worsening Heart Failure,” was presented at HFSA 2022.