Key Takeaways

For patients with heart failure, sodium-glucose co-transporters (SGLT) are one of the first lines of defense pharmaceutically, according to the American Heart Association, the Heart Failure Society of America, and the American College of Cardiologists.Patients now have an even better chance at survival with the recent FDA approval of Inpefa, the brand name of the drug sotagliflozin. It is the first sodium glucose cotransporter (SGLT) inhibitor that addresses glucose reabsorption in both the kidneys and the small intestine.

What Are SGLT Inhibitors?

According toJana Abelovska, MPharm, superintendent pharmacist of Click Pharmacy, SGLT inhibitors help control blood sugars after eating.

“SGLT1 inhibitors are a type of drug that delay and reduce glucose absorption in the small intestine,” Abelovska told Verywell. “SGLT2 proteins are located in the renal tubules of the kidney, which reabsorb glucose back into the blood. Because of this, SGLT2 inhibitors prevent this reabsorption and cause more glucose to be excreted in the urine. SGLT2 inhibitors effectively lower hemoglobin A1c levels, leading to improved weight loss and lowered blood sugar levels.”

When SGLT1 inhibitors are taken, they prevent the small intestine from reabsorbing glucose, especially after a meal. Delaying or preventing that absorption keeps blood glucose levels stable after eating, especially for heart patients and those with uncontrolled diabetes.

What Makes Inpefa Different?

SGLT inhibitors are already a tool in the cardiologist’s toolbox, but Inpefa is the first drug to address glucose absorption in both the kidneys and small intestine, according to Sandra V. Chaparro, MD, cardiologist and director of Advanced Heart Failure at the Miami Cardiac and Vascular Institute.

“Inpefa is the only compound that has the action of the SGLT1/2 receptors’ inhibitors,” Chaparro told Verywell. “We have four different SGLT2 inhibitors on the market, but Inpefa is the only one with dual activity. SGLT2 blocks the receptor and inhibits glucose reabsorption in the kidney, and SGLT1 does the same in the intestine.”

Although empagliflozin and dapagliflozin are both FDA-approved for use with patients with kidney disease and cardiovascular issues, only sotagliflozin, known as Inpefa, has proven efficacy in reducing heart attacks, strokes, and readmission to the hospital.

“As Inpefa contains both SGLT1 and SGLT2 inhibitors, targeting glucose reabsorption in two different parts of the body, its effectiveness is much higher than one type of inhibitor individually,” Abelovska said. “This can significantly reduce the risk of hospitalization for heart failure in diabetics.”

A Long Road to Approval

The FDA approved Inpefa in late May 2023, but drug maker Lexicon has been seeking approval for quite some time. Inpefa was initially rejected for authorization to treat type 1 diabetes due to the potential fordiabetic ketoacidosis. Subsequently, it was rejected for approval for heart failure due to a technical error in its application. Lexicon voluntarily withdrew it from consideration and resubmitted the application, at which time it was approved.

Abelovska said this is a testament to the thoroughness of the FDA approval process.

“Patient safety is the heart of the FDA approval system,” Abelovska said. “Ultimately, the FDA having taken several attempts to approve the drug is a testament to how thoroughly researched Inpefa has been prior to its approval.”

Chaparro agrees.

“When you apply for an indication, the FDA requests to see a specific trial that addresses that point,” Chaparro said. “The trials published on this medicine focused on decreasing heart attacks and strokes, but it wasn’t included in patients with type 2 diabetes. It was not addressing glycemic control, and that’s what the FDA was looking for.”

What This Means For You

3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Heidenreich PA, Bozkurt B, Aguilar D, et al.2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063Bhatt DL, Szarek M, Steg PG, et al.Sotagliflozin in patients with diabetes and recent worsening heart failure.N Engl J Med. 2021;384(2):117-128. doi:10.1056/NEJMoa2030183Bhatt DL, Szarek M, Pitt B, et al.Sotagliflozin in patients with diabetes and chronic kidney disease.N Engl J Med. 2021;384(2):129-139. doi:10.1056/NEJMoa2030186

3 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Heidenreich PA, Bozkurt B, Aguilar D, et al.2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063Bhatt DL, Szarek M, Steg PG, et al.Sotagliflozin in patients with diabetes and recent worsening heart failure.N Engl J Med. 2021;384(2):117-128. doi:10.1056/NEJMoa2030183Bhatt DL, Szarek M, Pitt B, et al.Sotagliflozin in patients with diabetes and chronic kidney disease.N Engl J Med. 2021;384(2):129-139. doi:10.1056/NEJMoa2030186

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Heidenreich PA, Bozkurt B, Aguilar D, et al.2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063Bhatt DL, Szarek M, Steg PG, et al.Sotagliflozin in patients with diabetes and recent worsening heart failure.N Engl J Med. 2021;384(2):117-128. doi:10.1056/NEJMoa2030183Bhatt DL, Szarek M, Pitt B, et al.Sotagliflozin in patients with diabetes and chronic kidney disease.N Engl J Med. 2021;384(2):129-139. doi:10.1056/NEJMoa2030186

Heidenreich PA, Bozkurt B, Aguilar D, et al.2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063

Bhatt DL, Szarek M, Steg PG, et al.Sotagliflozin in patients with diabetes and recent worsening heart failure.N Engl J Med. 2021;384(2):117-128. doi:10.1056/NEJMoa2030183

Bhatt DL, Szarek M, Pitt B, et al.Sotagliflozin in patients with diabetes and chronic kidney disease.N Engl J Med. 2021;384(2):129-139. doi:10.1056/NEJMoa2030186

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