PROVEN IN PATIENTS WITH HFrEF WITH & WITHOUT T2D

FARXIGA offers life-saving benefit by reducing CV death or hospitalization for heart failure1,2

FARXIGA is the only SGLT2i indicated to reduce CV death in patients with HFrEF with and without T2D.1,3-5
Start FARXIGA today for simple, foundational therapy in your newly diagnosed patients with HFrEF.


ACC Expert Consensus Decision Pathway

Now recommended as a component of first-line therapy according to the 2021 ACC Expert Consensus Decision Pathway6,*,†

*2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction.

SGLT2i is recommended as first-line therapy; FARXIGA is the only SGLT2i FDA approved for use in patients with HFrEF with and without T2D as discussed in the 2021 ACC Expert Consensus Decision Pathway.6

*2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction.

SGLT2i is recommended as a component of first-line therapy; FARXIGA is the only SGLT2i FDA approved for use in patients with HFrEF with and without T2D as discussed in the 2021 ACC Expert Consensus Decision Pathway.6

Efficacy

IN PATIENTS WITH HFrEF WITH & WITHOUT T2D

In DAPA-HF, FARXIGA significantly reduced CV death or hospitalization for heart failure1,2,*

Primary end point: Composite of CV death or hospitalization for heart failure1,2,*

CV Death or Hospitalization for Heart Failure
CV Death or Hospitalization for Heart Failure

Risk reduction driven by both CV death and hospitalization for heart failure1,2

Risk Reduction by CV Death and Hospitalization for Heart Failure
Risk Reduction by CV Death and Hospitalization for Heart Failure

Results for the primary composite end point of CV death or hospitalization for heart failure were consistent across subgroups1,7,8,*

Results Across Subgroups
Results Across Subgroups

Patients taking FARXIGA experienced a greater improvement in KCCQ-TSS between baseline and 8 months than those taking placebo2,‡

*Also includes urgent visits for heart failure.1

Data represented over a median follow-up of 18.2 months.2

KCCQ-TSS is a validated patient-reported outcome measurement which assesses the symptom frequency and symptom burden of heart failure.9 KCCQ-TSS is a prespecified secondary end point in DAPA-HF. KCCQ-TSS change from baseline to 8 months was 6.1 for FARXIGA and 3.3 for placebo. Clinically meaningful difference established as a 5-point change from baseline.2 A lower KCCQ score is associated with subsequent CV mortality and hospitalization for heart failure.10


Safety

FARXIGA has a proven safety profile, so you can prescribe early

Low rates of serious AEs for hypotension (0.3%) and hyperkalemia (0.1%)11
No incidences of severe hypoglycemia in patients with HFrEF without T2D7,*

DAPA-HF safety data in patients with and without T2D7,†

DAPA-HF Safety Data
DAPA-HF Safety Data

DAPA-HF Safety Data

  • FARXIGA did not negatively impact A1C (mean A1C of 5.74 at baseline and 5.79 at 24 months)8
  • In DAPA-HF, FARXIGA had low rates of urinary tract infection (0.6%) and genital mycotic infection (0.3%) compared to 0.7%, and no reported cases respectively in placebo group8

*Severe hypoglycemia defined as hypoglycemia requiring the assistance of another person to actively administer carbohydrates, glucagon, or take other corrective action.7

The safety population included patients receiving ≥1 dose of trial medication: FARXIGA n=2368 and placebo n=2368.7

Warnings and Precautions

  • Volume Depletion: FARXIGA can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating FARXIGA in these patients, assess volume status and renal function. After initiating therapy, monitor for signs and symptoms of hypotension and renal function
  • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA

Pooled safety data across 12 placebo-controlled clinical studies of glycemic control in patients with T2D1

Adverse reactions reported in ≥2% of patients treated with FARXIGA

Pooled Safety Data
Pooled Safety Data
  • Additional common AEs seen in >2% of patients taking FARXIGA included back pain, dyslipidemia, nasopharyngitis,  nausea, and influenza1

n for females: FARXIGA 10 mg=598, placebo=677; n for males: FARXIGA 10 mg=595, placebo=716.1


Study Design

The landmark DAPA-HF trial is the largest SGLT2i study to date for patients with HFrEF1,2,*

Study Design
Study Design

*As of May 2021.


ACC=American College of Cardiology; ACEI=angiotensin-converting enzyme inhibitor; AE=adverse event; ARB=angiotensin II receptor blocker; ARNI=angiotensin receptor-neprilysin inhibitor; ARR=absolute risk reduction; BB=beta blocker; CKD=chronic kidney disease; CV=cardiovascular; DAPA-HF=Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; eGFR=estimated glomerular filtration rate; FDA=US Food and Drug Administration; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; KCCQ-TSS=Kansas City Cardiomyopathy Questionnaire Total Symptom Score; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist; NNT=number needed to treat; NT-proBNP=N-terminal pro B-type natriuretic peptide; NYHA=New York Heart Association; RAASi=renin-angiotensin aldosterone system inhibitor; RRR=relative risk reduction; SGLT2=sodium-glucose cotransporter 2; SGLT2i=sodium-glucose cotransporter 2 inhibitor; SoC=standard of care; T2D=type 2 diabetes.

IMPORTANT SAFETY INFORMATION FOR FARXIGA