From the Guidelines
Yes, Farxiga (dapagliflozin) is approved for heart failure with preserved ejection fraction (HFpEF). The most recent and highest quality study, the DELIVER trial 1, demonstrated that dapagliflozin reduced the composite risk of cardiovascular death and worsening heart failure in patients with HFpEF.
Key Findings
- The DELIVER trial showed an 18% reduction in the primary outcome of a composite of worsening heart failure, defined as hospitalization or urgent visit for heart failure, or cardiovascular death in individuals treated with dapagliflozin compared with placebo (HR 0.82 [95% CI 0.73–0.92]; P < 0.001) 1.
- Approximately 44% of individuals randomized to either dapagliflozin or placebo had type 2 diabetes, and results were consistent regardless of the presence of type 2 diabetes 1.
- A large recent meta-analysis of data from EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, DELIVER, and the Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial included 21,947 individuals and demonstrated reduced risk for the composite of cardiovascular death or hospitalization for heart failure, cardiovascular death 1.
Recommendations
- The recommended dose is 10 mg once daily, taken orally with or without food.
- Patients should be monitored for potential side effects including genital mycotic infections, urinary tract infections, volume depletion, and ketoacidosis.
- Farxiga works as an SGLT2 inhibitor, which promotes glucose excretion through the urine and has beneficial effects on cardiac function, including reduced cardiac preload and afterload, improved ventricular filling, and reduced myocardial oxygen demand 1.
Mechanism of Action
- These mechanisms help explain its effectiveness in heart failure regardless of ejection fraction status or the presence of diabetes 1.
From the FDA Drug Label
The efficacy and safety of dapagliflozin 10 mg were assessed independently in two Phase 3 trials in adult patients with heart failure Dapagliflozin And Prevention of Adverse outcomes in Heart Failure (DAPA-HF, NCT03036124) was an international, multicenter, randomized, double-blind, placebo-controlled trial in patients with heart failure [New York Heart Association (NYHA) functional class II-IV] with reduced ejection fraction [left ventricular ejection fraction (LVEF) 40% or less] Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure (DELIVER, NCT03619213) was an international, multicenter, randomized, double-blind, placebo-controlled trial in patients aged ≥40 years with heart failure (NYHA class II-IV) with LVEF >40% and evidence of structural heart disease
Dapagliflozin, also known as Farxiga, is approved for the treatment of heart failure. The DAPA-HF trial focused on patients with reduced ejection fraction (HFrEF), while the DELIVER trial focused on patients with preserved ejection fraction (HFpEF).
- Key findings from the DELIVER trial show that dapagliflozin reduced the incidence of the primary composite endpoint of CV death, hospitalization for heart failure, or urgent heart failure visit in patients with HFpEF.
- The results of the DELIVER trial support the use of dapagliflozin in patients with HFpEF, as it demonstrated a significant reduction in the risk of cardiovascular death and hospitalization for heart failure 2.
From the Research
Farxiga Approval for HFpEF
- Farxiga, also known as dapagliflozin, has been studied in several clinical trials for its effectiveness in treating heart failure with preserved ejection fraction (HFpEF) 3, 4, 5, 6.
- The DELIVER trial, a randomized, double-blind trial, found that dapagliflozin reduced the risk of worsening heart failure or cardiovascular death in patients with HFpEF 3.
- The study results showed that dapagliflozin was effective in reducing the primary outcome of worsening heart failure or cardiovascular death, with a hazard ratio of 0.82 (95% CI, 0.73 to 0.92; P<0.001) 3.
- Another study found that dapagliflozin improved patient-reported symptoms, physical limitations, and exercise function in patients with HFpEF, with a significant improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) 6.
- The DAPA ACT HF-TIMI 68 trial is currently evaluating the initiation of dapagliflozin in patients hospitalized for acute heart failure, including those with HFpEF 7.
Key Findings
- Dapagliflozin has been shown to be effective in reducing the risk of worsening heart failure or cardiovascular death in patients with HFpEF 3, 4.
- The medication has also been found to improve patient-reported symptoms, physical limitations, and exercise function in patients with HFpEF 6.
- The safety profile of dapagliflozin in patients with HFpEF has been found to be similar to that of placebo, with no significant differences in adverse events 3, 6.