Published Data in The Lancet Diabetes & Endocrinology Highlights Unique Efficacy Benefits of Sotagliflozin to Reduce Major Adverse Cardiovascular Events (MACE)
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that The Lancet Diabetes & Endocrinology published a study highlighting the unique efficacy of sotagliflozin in reducing major adverse cardiovascular events (MACE). The study, a secondary analysis of the SCORED randomized trial, demonstrated that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, significantly reduced the risk of heart attack (MI) and stroke in patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular (CV) risk.
Patients on sotagliflozin had a lower rate of MACE outcomes (4.8 events per 100 person-years [p-y]) compared to placebo (6.3 events per 100 p-y) with a hazard ratio (HR) of 0.77, 95% confidence interval (CI) of 0.65-0.91, and P=0.002. The drug also reduced the rate of MI (1.8 events per 100 p-y vs. 2.7 events per 100 p-y, HR: 0.68, 95% CI: 0.52-0.89, P=0.004) and stroke (1.2 events per 100 p-y vs. 1.8 events per 100 p-y, HR: 0.66, 95% CI: 0.48-0.91, P=0.012).
Dr. Deepak L. Bhatt, Director at Mount Sinai Fuster Heart Hospital, emphasized that sotagliflozin is the only SGLT inhibitor to show significant reductions in both heart attack and stroke.
Lexicon Pharmaceuticals (Nasdaq: LXRX) ha annunciato che The Lancet Diabetes & Endocrinology ha pubblicato uno studio che evidenzia l'unicità dell'efficacia di sotagliflozin nella riduzione degli eventi cardiovascolari avversi maggiori (MACE). Lo studio, un'analisi secondaria del trial randomizzato SCORED, ha dimostrato che sotagliflozin, un inibitore duale di SGLT1 e SGLT2, ha ridotto significativamente il rischio di infarto (MI) e ictus nei pazienti con diabete di tipo 2 (T2D), malattia renale cronica (CKD) e alto rischio cardiovascolare (CV).
I pazienti trattati con sotagliflozin hanno mostrato un tasso più basso di risultati MACE (4.8 eventi per 100 anni-persona [p-y]) rispetto al placebo (6.3 eventi per 100 p-y), con un rapporto di rischio (HR) di 0.77, un intervallo di confidenza (CI) del 95% di 0.65-0.91, e P=0.002. Il farmaco ha anche ridotto il tasso di MI (1.8 eventi per 100 p-y contro 2.7 eventi per 100 p-y, HR: 0.68, 95% CI: 0.52-0.89, P=0.004) e ictus (1.2 eventi per 100 p-y contro 1.8 eventi per 100 p-y, HR: 0.66, 95% CI: 0.48-0.91, P=0.012).
Il Dr. Deepak L. Bhatt, Direttore del Mount Sinai Fuster Heart Hospital, ha sottolineato che sotagliflozin è l'unico inibitore SGLT a mostrare riduzioni significative sia per infarto che per ictus.
Lexicon Pharmaceuticals (Nasdaq: LXRX) anunció que The Lancet Diabetes & Endocrinology publicó un estudio que destaca la eficacia única de sotagliflozina en la reducción de eventos cardiovasculares adversos mayores (MACE). El estudio, un análisis secundario del ensayo aleatorio SCORED, demostró que sotagliflozina, un inhibidor dual de SGLT1 y SGLT2, redujo significativamente el riesgo de infarto (MI) y accidente cerebrovascular en pacientes con diabetes tipo 2 (T2D), enfermedad renal crónica (CKD) y alto riesgo cardiovascular (CV).
Los pacientes tratados con sotagliflozina tuvieron una tasa más baja de resultados MACE (4.8 eventos por 100 años-persona [p-y]) en comparación con el placebo (6.3 eventos por 100 p-y), con una razón de riesgo (HR) de 0.77, un intervalo de confianza (CI) del 95% de 0.65-0.91, y P=0.002. El medicamento también redujo la tasa de MI (1.8 eventos por 100 p-y frente a 2.7 eventos por 100 p-y, HR: 0.68, 95% CI: 0.52-0.89, P=0.004) y accidente cerebrovascular (1.2 eventos por 100 p-y frente a 1.8 eventos por 100 p-y, HR: 0.66, 95% CI: 0.48-0.91, P=0.012).
El Dr. Deepak L. Bhatt, Director del Mount Sinai Fuster Heart Hospital, enfatizó que sotagliflozina es el único inhibidor de SGLT que ha mostrado reducciones significativas tanto en infartos como en accidentes cerebrovasculares.
Lexicon Pharmaceuticals (Nasdaq: LXRX)는 The Lancet Diabetes & Endocrinology가 sotagliflozin의 독특한 효능을 강조하는 연구를 발표했다고 발표했습니다. 이 연구는 SCORED 무작위 시험의 2차 분석으로, SGLT1 및 SGLT2의 이중 억제제인 sotagliflozin이 제2형 당뇨병(T2D), 만성 신장 질환(CKD) 및 높은 심혈관(CV) 위험을 가진 환자에서 심장마비(MI) 및 뇌졸중의 위험을 유의미하게 감소시켰음을 보여주었습니다.
sotagliflozin을 복용한 환자는 위약(100인년당 6.3건)과 비교하여 MACE 결과의 비율이 낮았습니다(100인년당 4.8건), 위험비(HR)는 0.77, 95% 신뢰구간(CI)은 0.65-0.91, P=0.002입니다. 이 약물은 또한 MI의 비율을 줄였습니다(100인년당 1.8건 대 100인년당 2.7건, HR: 0.68, 95% CI: 0.52-0.89, P=0.004) 및 뇌졸중(100인년당 1.2건 대 100인년당 1.8건, HR: 0.66, 95% CI: 0.48-0.91, P=0.012).
Mount Sinai Fuster Heart Hospital의 Dr. Deepak L. Bhatt는 sotagliflozin이 심장마비와 뇌졸중 모두에서 유의미한 감소를 보인 유일한 SGLT 억제제라고 강조했습니다.
Lexicon Pharmaceuticals (Nasdaq: LXRX) a annoncé que The Lancet Diabetes & Endocrinology a publié une étude mettant en lumière l'efficacité unique de la sotagliflozine dans la réduction des événements cardiovasculaires indésirables majeurs (MACE). L'étude, une analyse secondaire de l'essai randomisé SCORED, a démontré que la sotagliflozine, un inhibiteur dual de SGLT1 et SGLT2, a significativement réduit le risque d'infarctus (MI) et d'accident vasculaire cérébral chez les patients atteints de diabète de type 2 (T2D), de maladie rénale chronique (CKD) et de risque cardiovasculaire élevé (CV).
Les patients sous sotagliflozine ont présenté un taux plus bas d'événements MACE (4,8 événements pour 100 années-personnes [p-y]) par rapport au placebo (6,3 événements pour 100 p-y), avec un rapport de risques (HR) de 0,77, un intervalle de confiance (CI) de 95 % de 0,65-0,91, et P=0,002. Le médicament a également réduit le taux d'infarctus (1,8 événements pour 100 p-y contre 2,7 événements pour 100 p-y, HR : 0,68, 95 % CI : 0,52-0,89, P=0,004) et d'accident vasculaire cérébral (1,2 événements pour 100 p-y contre 1,8 événements pour 100 p-y, HR : 0,66, 95 % CI : 0,48-0,91, P=0,012).
Le Dr. Deepak L. Bhatt, directeur de l'hôpital cardiaque Mount Sinai Fuster, a souligné que la sotagliflozine est le seul inhibiteur de SGLT à montrer des réductions significatives tant pour les infarctus que pour les AVC.
Lexicon Pharmaceuticals (Nasdaq: LXRX) gab bekannt, dass The Lancet Diabetes & Endocrinology eine Studie veröffentlicht hat, die die einzigartige Wirksamkeit von Sotagliflozin bei der Reduzierung von schwerwiegenden unerwünschten kardiovaskulären Ereignissen (MACE) hervorhebt. Die Studie, eine sekundäre Analyse der randomisierten SCORED-Studie, zeigte, dass Sotagliflozin, ein dualer SGLT1- und SGLT2-Inhibitor, das Risiko für Herzinfarkt (MI) und Schlaganfall bei Patienten mit Typ-2-Diabetes (T2D), chronischer Nierenerkrankung (CKD) und hohem kardiovaskulären (CV) Risiko signifikant senkte.
Patienten, die Sotagliflozin einnahmen, hatten eine niedrigere Rate an MACE-Ergebnissen (4,8 Ereignisse pro 100 Personenjahre [p-y]) im Vergleich zu Placebo (6,3 Ereignisse pro 100 p-y), mit einem Hazard Ratio (HR) von 0,77, einem 95%-Konfidenzintervall (CI) von 0,65-0,91 und P=0,002. Das Medikament reduzierte auch die Rate von MI (1,8 Ereignisse pro 100 p-y gegenüber 2,7 Ereignisse pro 100 p-y, HR: 0,68, 95% CI: 0,52-0,89, P=0,004) und Schlaganfall (1,2 Ereignisse pro 100 p-y gegenüber 1,8 Ereignisse pro 100 p-y, HR: 0,66, 95% CI: 0,48-0,91, P=0,012).
Dr. Deepak L. Bhatt, Direktor des Mount Sinai Fuster Heart Hospital, betonte, dass Sotagliflozin der einzige SGLT-Inhibitor ist, der signifikante Reduzierungen sowohl bei Herzinfarkten als auch bei Schlaganfällen zeigt.
- Sotagliflozin significantly reduces major adverse cardiovascular events (MACE) in high-risk patients.
- The drug shows unique efficacy in lowering heart attack and stroke rates compared to other SGLT inhibitors.
- Sotagliflozin reduced MACE rates to 4.8 events per 100 person-years from 6.3 events per 100 person-years with placebo.
- Heart attack rates decreased to 1.8 events per 100 person-years from 2.7 events per 100 person-years with placebo.
- Stroke rates reduced to 1.2 events per 100 person-years from 1.8 events per 100 person-years with placebo.
- None.
Insights
The publication of sotagliflozin's SCORED trial analysis in The Lancet Diabetes & Endocrinology represents a pivotal development for Lexicon Pharmaceuticals, demonstrating unprecedented efficacy in reducing cardiovascular events. The data reveals several critical advantages:
Key statistical outcomes:
- MACE reduction:
23% (HR: 0.77, p=0.002) - Myocardial infarction reduction:
32% (HR: 0.68, p=0.004) - Stroke reduction:
34% (HR: 0.66, p=0.012)
The dual SGLT1 and SGLT2 inhibition mechanism of sotagliflozin creates a distinct competitive advantage in the $25 billion SGLT inhibitor market. This differentiation is particularly significant as it addresses a critical gap in current treatment options for high-risk cardiovascular patients with type 2 diabetes and chronic kidney disease.
The market implications are substantial. Cardiovascular complications represent the largest cost burden in diabetes care, with annual expenses exceeding
The validation from a prestigious peer-reviewed journal strengthens Lexicon's position in discussions with payers and healthcare providers. This could accelerate market adoption, particularly among cardiologists and endocrinologists who treat high-risk patients where the drug's dual mechanism provides clear advantages over existing options.
Data reinforce unique clinical advantages of sotagliflozin
Published study is aligned with research presented in December 2024 at the American Society of Hematology showing clinical benefits of sotagliflozin compared to empagliflozin
THE WOODLANDS, Texas, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced The Lancet Diabetes & Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardiovascular outcomes.
The findings from the study, “Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” concluded that the ischemic benefit of sotagliflozin on both heart attack (myocardial infarction, or MI), and stroke reduction has not been shown by other SGLT inhibitors. The researchers note that sotagliflozin reduced major adverse cardiovascular events (MACE), MI, and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular (CV) risk.
The study was a secondary analysis of SCORED, a double-blind, placebo-controlled, randomized clinical trial enrolling patients with T2D and CKD. A pre-specified outcome was total MACE, which was defined as a composite of total CV death, nonfatal MI, and nonfatal stroke. Other outcomes included total MI and total stroke.
Patients in the sotagliflozin group had a lower rate of MACE outcomes (4.8 events per 100 person-years [p-y]) compared with the placebo group (6.3 events per 100 p-y) (hazard ratio [HR]: 0.77;
“Our research team found that sotagliflozin is the only SGLT inhibitor to demonstrate significant reduction of both heart attack and stroke,” said Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, Director, of the Mount Sinai Fuster Heart Hospital, and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. The Icahn School of Medicine receives research funding for Dr. Bhatt’s role as the Chair of SCORED.
“When you look at the published and presented findings holistically, you get a clear picture of how and why sotagliflozin stands apart from all other SGLT inhibitors,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
Click here to access the study abstract published by The Lancet Diabetes & Endocrinology on February 14, 2025.
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, 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 and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to sotagliflozin and Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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