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Lexicon Welcomes New ESC Heart Failure Treatment Guidelines Establishing SGLT Inhibitors as Standard of Care
Lexicon Pharmaceuticals, Inc.
Mon, August 30, 2021, 1:00 PM·4 min read
In this article:
New guidelines from the European Society of Cardiology recommend addition of SGLT inhibitors to standard of care for patients with acute and chronic heart failure.
Guidance underscores the benefits of SGLT inhibitors in significantly reducing risk of death due to cardiovascular causes or heart failure hospitalization.
THE WOODLANDS, Texas, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) welcomes the new recommendation by the European Society of Cardiology (ESC) to add SGLT inhibitors as part of the standard of care for the prevention and treatment of heart failure (HF). SGLT inhibitors have been given a Class IA recommendation-- the strongest endorsement-- in updated clinical practice guidelines released by the ESC Heart Failure working group in the EU at its annual meeting, the ESC Congress 2021 - The Digital Experience.
Specifically, the guidelines recommend the following for the primary prevention of HF in patients with risk factors for its development:
“SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with diabetes at high risk of cardiovascular (CV) disease or with CV disease in order to prevent HF hospitalizations.”
The guidelines recommend the following for the treatment of patients with HF and diabetes or for the treatment of diabetes in HF:
“SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with type 2 diabetes mellitus (T2DM) at risk of CV events to reduce hospitalizations for HF, major CV events, end-stage renal dysfunction, and CV death.”
“SGLT2 inhibitors (dapagliflozin, empagliflozin, and sotagliflozin) are recommended in patients with T2DM and heart failure with reduced ejection fraction (HFrEF) to reduce hospitalizations for HF and CV death.”
The guidelines also addressed worsening heart failure, noting:
“The combined SGLT-1 and 2 inhibitor, sotagliflozin, has also been studied in patients with diabetes who were hospitalized with HF. The drug reduced CV death and hospitalization for HF.”
“Safety and better outcome have also been recently shown in a prospective randomized trial with sotagliflozin in diabetic patients hospitalized for HF, irrespective of their left ventricular ejection fraction (LVEF).”
“It is quite rare for an investigational drug to be listed in the guidelines prior to regulatory approval and we do not take the trust and confidence that ESC has placed in sotagliflozin lightly,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer at Lexicon. “We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies for acute and chronic heart failure. We continue to work diligently for these patients and plan to submit a New Drug Application with the U.S. Food and Drug Administration later this year for its review of sotagliflozin, as a therapy for people suffering from heart failure and living with type 2 diabetes.”
The full 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure can be found at escardio.org.
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched. Sotagliflozin is not approved for use in any other indications, including heart failure.
