Sotagliflozin, sold under the brand nameInpefa among others, is a medication used to reduce the risk of death due toheart failure.[1] It is an inhibitor of sodium-glucose cotransporter 1 and 2 (SGLT1/SGLT2 inhibitor).[1] It is takenby mouth.[1]
Sotagliflozin was approved for medical use in the European Union in April 2019, asZynquista, for the treatment fortype 1 diabetes,[2] and in the United States in May 2023,[3] to reduce the risk of death due to heart failure.[1][4] The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022, at the request of the marketing-authorization holder.[2]
In the United States, sotagliflozin isindicated 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, chronic kidney disease, and other cardiovascular risk factors.[1][3]
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.[5]
The USFood and Drug Administration (FDA) approved sotagliflozin based on evidence from two clinical trials of 11,806 total participants with heart failure or with type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.[3] The trials were conducted at 322 sites in 32 countries (SOLOIST/NCT03521934[1][6]) and 750 sites in 42 countries (SCORED/NCT03315143[1][7]) primarily in Europe, South America, and North America.[3] Both trials were used for primary determination of the benefits and side effects of the drug.[3] The benefits and side effects of sotagliflozin were evaluated in the two clinical trials.[3] In both trials, participants were randomly assigned to receive either sotagliflozin or placebo by mouth once a day.[3] Neither the participants nor the healthcare providers knew which treatment was being given until after the trial was completed.[3] The benefit of sotagliflozin was evaluated by measuring the number of predefined events (death from cardiovascular causes, need for hospitalization for heart failure, or urgent medical care visit for heart failure) occurring in the patient population receiving sotagliflozin versus placebo.[3]
In May 2023, the US FDA approved sotagliflozin (Inpefa) 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, chronic kidney disease, and other cardiovascular risk.[3][4]
The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022, at the request of the marketing-authorization holder.[2]
Combination of insulin with sotaglifozin 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.[10]
^abcd"Zynquista EPAR".European Medicines Agency (EMA). 27 February 2019.Archived from the original on 3 November 2020. Retrieved28 October 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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