Dr Veena Aggarwal
Physicians treating patients with heart failure now have a new treatment option for reducing re-hospitalizations for heart failure. The US FDA has approved sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in patients with heart failure, both with preserved ejection fraction (HFpEF) and reduced ejection fraction (HFrEF).
It has also been approved in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors to prevent these events.
Sotagliflozin is the first dual sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor.
The approval of sotagliflozin is based on the results from the SOLOIST-WHF (Worsening Heart Failure) trial in which sotagliflozin treatment of type 2 diabetes patients who had been recently hospitalized for worsening heart failure led to 33% reduction in the risk of the composite of hospitalizations for heart failure, urgent visits for heart failure and cardiovascular death over a median follow-up of 9 months compared to controls. The drug was also safe. In an exploratory post hoc analysis of the SOLOIST-WHF trial, sotagliflozin reduced 30- and 90-day re-hospitalization rates by nearly 50%.
Side effects: Urinary tract infection, volume depletion, diarrhea, hypoglycemia
Contraindication: Patients with hypersensitivity to sotagliflozin or any of its components
Warning and precautions
- Assess renal function and volume status before starting treatment. In patients with decompensated heart failure, start treatment when they are hemodynamically stable.
- Increased risk of ketoacidosis in patients with type 1 diabetes mellitus. Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors. Hence, monitor for ketones in T1DM patients and others at risk for ketoacidosis.
- Elderly patients, patients on loop diuretics or those with impaired renal function (eGFR < 60 mL/min/1.73 m2) are at higher risk for hypotension.
- Evaluate patients for signs and symptoms of urinary tract infections and Monitor and genital mycotic infections.
- Concomitant use in patients on insulin or insulin secretagogues may increase the risk of hypoglycemia.
Sources https://www.lexpharma.com/media-center/news/2023-05-26-lexicon-announces-fda-approval-of-inpefa-sotagliflozin-for-treatment-of-heart-failure. May 26, 2023. Accessed on June 1, 2023.
FDA approves new drug, sotagliflozin, for heart failure – Medscape – May 26, 2023.
Dr Veena Aggarwal, Consultant Womens’ Health, CMD and Editor-in-Chief, IJCP Group & Medtalks Trustee, Dr KK’s Heart Care Foundation of India