PROVEN IN PATIENTS WITH T2D & MULTIPLE CV RISK FACTORS OR eCVD

Act now with FARXIGA to help prevent the first hospitalization for heart failure

FARXIGA is proven to help protect against hospitalization for heart failure in patients like those you see in your practice every day, with T2D and CV risk factors.

Efficacy

IN PATIENTS WITH T2D & MULTIPLE CV RISK FACTORS OR eCVD

Act now to help keep your patients out of the hospital due to heart failure

The only SGLT2i studied in a CVOT with a majority of primary prevention patients (multiple CV risk factors)1-3,*

Efficacy in Patients with T2D and Multiple CV Risk Factors
Efficacy in Patients with T2D and Multiple CV Risk Factors

27% RRR for hospitalization for heart failure in the overall patient population (component of the primary end point); (HR, 0.73; 95% CI, 0.61-0.88; 0.8% ARR)5

  • 22% RRR for hospitalization for heart failure in patients with eCVD (secondary prevention§); (HR, 0.78; 95% CI, 0.63-0.97; 1.2% ARR)6
  • FARXIGA met the primary safety end point vs placebo for the composite of CV death, MI, or ischemic stroke (MACE); (HR, 0.93; 95% CI, 0.84-1.03) P<0.001 (noninferiority). FARXIGA is not indicated to reduce the risk of MACE4

*Primary prevention defined as multiple CV risk factors (age ≥55 years in men or ≥60 years in women and at least 1 of the following: dyslipidemia, hypertension, or current tobacco use) and without a history of a CV event at baseline.1

Data represented as event rates over a median follow-up of 4.2 years.4,6

Hospitalization for heart failure indication is not limited by diabetic nephropathy or the presence of macroalbuminuria.1

§Secondary prevention defined as eCVD (clinically evident ischemic heart disease, ischemic cerebrovascular disease, or peripheral arterial disease).5,6


Safety

FARXIGA has a proven safety profile in patients across the heart failure risk continuum

Select AEs across CV clinical studies4,7-9

Safety Profile in Patients Across Heart Failure Risk Continuum
Safety Profile in Patients Across Heart Failure Risk Continuum

Safety Profile in Patients Across Heart Failure Risk Continuum

*In DECLARE, a renal AE was defined as an acute kidney injury.4

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

All cases of diabetic ketoacidosis occurred in patients with diabetes at baseline.7

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 Across 12 Placebo Controlled Clinical Studies of Glycemic Control in Patients with T2D
Pooled Safety Data Across 12 Placebo Controlled Clinical Studies of Glycemic Control in Patients with T2D
  • 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

DECLARE: The largest CVOT with an SGLT2i to study hospitalization for heart failure risk reduction in both primary and secondary prevention patients1-3,10,11

DECLARE Study Design
DECLARE Study Design

*DECLARE was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the effect of FARXIGA 10 mg compared with placebo on CV outcomes in adults with T2D and multiple CV risk factors or eCVD.1

Patients included were ≥40 years of age.4

Primary prevention defined as multiple CV risk factors (age ≥55 years in men or ≥60 years in women and at least 1 of the following: dyslipidemia, hypertension, or current tobacco use) and without a history of a CV event at baseline.1

§Secondary prevention defined as eCVD (clinically evident ischemic heart disease, ischemic cerebrovascular disease, or peripheral arterial disease).4


AE=adverse event; ARR=absolute risk reduction; CKD=chronic kidney disease; CV=cardiovascular; CVOT=cardiovascular outcomes trial; DAPA-HF=Dapagliflozin And Prevention of Adverse outcomes in Heart Failure; DECLARE=Dapagliflozin Effect on Cardiovascular Events; eCVD=established cardiovascular disease; HFrEF=heart failure with reduced ejection fraction; hHF=hospitalization for heart failure; HR=hazard ratio; MACE=major adverse cardiovascular events; MI=myocardial infarction; RRR=relative risk reduction; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

IMPORTANT SAFETY INFORMATION FOR FARXIGA