Dr. Ahmed
Farxiga has been approved by European Union for Heart Failure regardless of the status of the ejection fraction [Ref].
It has been proven to have a significant impact on mortality rates in patients with heart failure and mildly reduced ejection fraction as well as those with a preserved ejection fraction.
The approval was based on the two landmark studies: DAPA-HF and DELIVER Phase III Trials.
Farxiga (or Forxiga in Europe) is already approved for the treatment of:
- Type 2 Diabetes
- CKD, and
- HFrEF (Heart Failure with reduced Ejection Fraction)
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What is Heart Failure with Reduced and Preserved ejection fraction:
Heart Failure is basically a clinical diagnosis. Patients with heart failure have shortness of breath, and exercise intolerance, and are at an increased risk of death.
Heart failure is classified based on the ejection fraction. The ejection fraction is the percentage of blood that is pumped out of the left ventricle.
There are three classes of Heart Failure based on the ejection fraction:
- HFrEF (heart failure with reduced ejection fraction): The EF is 40% or less
- HFmrEF (heart failure with mildly reduced ejection fraction): The EF is 41% to 49%)
- HFpEF (heart failure with preserved ejection fraction): The EF is 50% or more.
More than half of the patients with heart failure have either preserved or mildly reduced ejection fraction (HFpEF or HFmrEF).
Empagliflozin (Jardiance) is another SGLT2 inhibitor that has been approved by the FDA for the treatment of heart failure with preserved ejection fraction.
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Farxiga Vs Jardiance for Heart Failure with Preserved Ejection Fraction:
Jardiance has been approved for the treatment of heart failure with preserved ejection fraction based on the EMPEROR-Preserved trial which showed an improvement in heart failure and reduced the risks of death [Ref]:
| Outcomes of The EMPEROR-Preserved Trial | Percentage Risk Reduction |
| Relative risk reduction in cardiovascular death or hospitalization | 27% improvement |
| Hospitalization for heart failure | 29% lower risk |
Farxiga is one of the potent SGLT2 inhibitors similar to Empagliflozin (Jardiance). It is marketed by AstraZeneca Pharmaceuticals.
The DELIVER Trial was conducted to set grounds for the approval of Dapagliflozin in patients with heart failure with preserved ejection fraction.
Dapagliflozin has already been approved for the treatment of heart failure with reduced ejection fraction. However, the DELIVER Trial enrolled all patients with heart failure regardless of the ejection fraction.
The results of the DELIVER Trial are consistent with the EMPEROR-preserved trial. It also included patients with EF of 60% or more.
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Here is a brief comparison of Farxiga and Jardiance (Dapagliflozin and Empagliflozin) in the treatment of patients with heart failure and preserved ejection fraction:
DELIVER Trial |
EMPEROR-Preserved |
|
| Drug Studied | Dapagliflozin | Empagliflozin |
| Dose | 10 mg | 10 mg |
| Patients selection | Heart Failure with EF of more than 40% | Class II-IV heart failure with EF of more than 40% |
| Number of patients | 6263 | 5988 |
| Primary outcome | 1. Worsening heart failure
2. Cardiovascular death |
1. Hospitalization for heart failure
2. Cardiovascular death |
| Duration of study | 27.6 months | 26.2 months |
Outcomes of the DELIVER Trial that evaluated the role of Dapagliflozin in patients with heart failure and a preserved ejection fraction [Ref]:
| Study group (N= 3131) | Placebo (N= 3132) | Significance | |
| The primary outcome in the DAPA group | 16.4% (512) | 19.5% (610) | HR: 0.82 (CI: 0.73 – 0.92)
P: <0.001 |
| Worsening heart failure | 11.8% (368) | 14.5% (455) | HR: 0.79 (CI: 0.69 – 0.91)
|
| Cardiovascular death | 7.4% (231) | 8.3% (261) | HR: 0.88 (CI: 0.74 – 1.05) |
Outcomes of the EMPEROR-preserved trial that evaluated the role of Empagliflozin in patients with heart failure and preserved ejection fraction [Ref]:
| Study group (N = 2997) | Placebo (N=2991) | Significance | |
| The primary outcome in the Empa group | 13.8% (415) | 17.1% (511) | HR: 0.79 (CI: 0.69 – 0.90)
P: <0.001 |
| Hospitalization for heart failure | 8.6% (259) | 11.8% (352) | HR: 0.71 (CI: 0.60 – 0.83)
|
| Cardiovascular death | 7.3% (219) | 8.2% (244) | HR: 0.91 (CI: 0.76 – 1.09) |
It is evident that both Empagliflozin and Dapagliflozin exert a beneficial effect, and reduce mortality and hospitalization due to heart failure in patients with heart failure regardless of the EF.
The company states that Farxiga can be prescribed to all patients with heart failure regardless of the ejection fraction. It covers the full spectrum of heart failure patients.
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In Conclusion:
Farxiga got EU approval for the treatment of heart failure across the spectrum of EF. It is already approved for the treatment of heart failure with reduced ejection fraction.
The DELIVER trial evaluated its role in the treatment of patients with mildly reduced ejection fraction as well as preserved ejection fraction.
There was a clear mortality benefit and the risks of hospitalization due to heart failure were reduced using Dapagliflozin.
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