Dr. Ahmed Sotagliflozin got FDA approval for the treatment of heart failure. On 26th May 2023, the FDA approved Inpefa tablets for treating patients with heart failure.
Originally, Sotagliflozin was approved in 2019 by the EMA (European Medical Agency) for treating patients with Type 1 Diabetes under the brand name Zynquista. The drug was approved in individuals with a BMI of 27 kg/m² or more and those with a lower risk of diabetic ketoacidosis.
However, because of the risk of euglycemic ketoacidosis and limited efficacy in individuals with Type 1 Diabetes, its use was discontinued.
Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor. It blocks the reabsorption of glucose into the blood from the kidneys as well as from the gut. Thus, it also lowers post-meal blood sugars
In addition, SGLT1 receptors are present in greater numbers in the myocytes and heart cells. However, whether this has any added advantage over SGLT2 inhibitors (Empagliflozin and Dapagliflozin) or not is not clear.
Inpefa Vs. Jardiance Vs. Farxiga for heart failure:
Inpefa (Sotagliflozin) has just been approved for treating symptomatic heart failure. On the other hand, Jardiance (Empagliflozin) was approved for the treatment of heart failure with reduced ejection fraction in August 2020. In February 2022, Jardiance also got FDA approval for heart failure with preserved ejection fraction.
Farxiga (Dapagliflozin) was approved in May 2021 for the treatment of heart failure with reduced ejection fraction. In February 2023, Farxiga also got approval for the treatment of heart failure with preserved ejection fraction.
The FDA Approval of Sotagliflozin (Inpefa) for treating heart failure was based on its efficacy in lowering the rates of deaths, hospitalizations, and urgent care visits in patients with or without diabetes. Compared to placebo, there was a 33% reduction in these outcome parameters [Ref].
In addition, like Jardiance, treatment with Sotagliflozin was initiated during the hospital or within 3 days of discharge from the hospital.
Inpefa Vs Jardiance: Comparing efficacies in heart failure:
Inpefa has just been approved while Jardiance has gained physicians’ and cardiologists’ trust as it’s been in use for more than 3 years.
It is important to note that Sotagliflozin may be best for patients with heart failure who have diabetes but it is not approved for the treatment of diabetes alone.
Here is a table of comparison of Sotagliflzin vs. Jardiance in patients with heart failure:
Brand Names | Inpefa | Jardiance |
| Drug Name | Sotagliflozin | Empagliflozin |
| Manufacturer | Lexicon | Boehringer Ingelheim, Eli Lilly |
| FDA-approved | Heart failure |
|
Efficacy in heart failure | ||
| Deaths from cardiovascular causes, hospitalization, and urgent visits due to heart failure | 33.2% (vs Placebo) | 21% vs placebo |
| Hospitalization and urgent care visits | 36.9% vs placebo | 35% vs placebo |
| Deaths from cardiovascular causes | 15.2% vs placebo | 38% vs placebo |
| Deaths from any cause | 17.2% vs placebo) | 32% vs placebo |
From the table above it is very clear that Jardiance and Inpefa are effective in the treatment of heart failure. However, because they have not been compared in a head-to-head trial, they may not be compared.
Inpefa Vs Farxiga: Comparing efficacies in heart failure:
Sotagliflozin and Farxiga had once been approved for the treatment of obese individuals with Type 1 diabetes. However, this indication has been withdrawn for both patients.
Farxiga is an FDA-approved drug for the treatment of Type 2 diabetes, CKD, and heart failure regardless of the ejection fraction.
Sotagliflozin, on the other hand, has only been approved for the treatment of patients with heart failure. Although diabetics with heart failure are the best candidates for Inpefa treatment, it is not approved for treating Diabetes alone.
Here is a table of comparison of Inpefa (Sotagliflozin) vs Farxiga (Dapagliflozin):
Brand Names | Inpefa | Farxiga |
| Drug Name | Sotagliflozin | Dapagliflozin |
| Manufacturer | Lexicon | AstraZeneca Pharmaceuticals |
| FDA-approved | Heart failure |
|
Efficacy in heart failure | ||
| Deaths from cardiovascular causes, hospitalization, and urgent visits due to heart failure | 33.2% (vs Placebo) | 26% vs placebo |
| Hospitalization and urgent care visits | 36.9% vs placebo | 30% vs placebo |
| Deaths from cardiovascular causes | 15.2% vs placebo | 2.9% (Vs 2.9%) |
| Deaths from any cause | 17.2% vs placebo) | 18% vs placebo |
It is evident from the table above that both Inpefa (Sotagliflozin) and Farxiga are effective in patients with heart failure. However, these drugs have not been compared in a head-to-head trial and the percentage risk reduction may be misleading.
Nevertheless, Inpefa (Sotagliflozin) has definitely proven to be beneficial in patients with heart failure.
It is not clear which patients may benefit from Stagliflozin, blocking both SGLT1 and SGLT2 receptors, and which patients may best respond to SGLT2 receptor inhibition (JArdiance and aFarxiga) alone.
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