LXRX - Lexicon to Present Post Hoc Analysis of Scored Clinical Trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 | Benzinga
INPEFA® (sotagliflozin) recently approved by FDA for treatment of heart failure
SCORED was one of two randomized, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies that led to FDA approval
THE WOODLANDS, Texas, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that a new analysis of clinical trial data for INPEFA® (sotagliflozin) will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, October 6-9, 2023 in Cleveland, Ohio.
Details of the presentation are as follows:
- Sotagliflozin Reduces The Risk Of Cardiovascular Events In Patients With Left Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis From SCORED – an ePoster presentation, Sunday, October 8, 8:00 - 8:30 a.m. ET, Viewing Session VI, Huntington Convention Center, presented by Michael J. Davies, PhD, executive director of clinical development, Lexicon Pharmaceuticals.
On May 26, 2023, the U.S. Food and Drug Administration approved INPEFA, a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
About INPEFA® (sotagliflozin)
Discovered using Lexicon's unique approach to gene science, INPEFA (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. INPEFA has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
INDICATION
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
IMPORTANT SAFETY INFORMATION
Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.
Contraindications: INPEFA is contraindicated in patients with hypersensitivity to any component.
Warnings and Precautions:
Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting ...