Sotagliflozin, sold under the brand name Inpefa among others, is a medication used to reduce the risk of death due to
heart failure.[1]
The most common side effect is genital infection in women.[2] Other common side effects include diabetic ketoacidosis, diarrhea, and genital infection in men.[2]
Sotagliflozin was approved for medical use in the European Union in April 2019, as Zynquista, for the treatment for
type 1 diabetes,[2] and in the United States in May 2023, to reduce the risk of death due to heart failure.[1][3] The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022.[2]
Medical uses
In the United States, sotagliflozin is
indicated to reduce the risk of cardiovascular death.[1] Sotaglifozin is a sodium-glucose co-transporter 1 and 2 inhibitor that reduces both postprandial glucose and insulin levels by delaying intestinal glucose absorption, decreases gastric inhibitory polypeptide, and elevations in glucagon-like peptide and peptide yy levels are consistent with local inhibition of intestinal SGLT1.[4] Combination of insulin with sotaglifozin 200 and 400 mg led to a significant lowering of systolic and diastolic blood pressure and multiple indirect markers of arterial stiffness, including pulse pressure, without changes in pulse rates.[5] Also, it decreased the incidence of myocardial infarction and stroke, pointing to a potential side effect of SGLT1 inhibition.[6]
In May 2023 the US FDA approved Inpefa (sotagliflozin), a once-daily oral tablet, to decrease 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.[10]
Clinical trial number NCT03521934 for "Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)" at
ClinicalTrials.gov
Clinical trial number NCT03315143 for "Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)" at
ClinicalTrials.gov