Currently Enrolling Trials
Farxiga (dapagliflozin) is an orally active sodium glucose cotransporter type 2 (SGLT-2) inhibitor. Inhibiting SGLT2 activity modulates reabsorption of glucose in the kidney, resulting in excretion of glucose in the urine.
Farxiga is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.
Farxiga is specifically indicated reduce the risk of hospitalization for heart failure in adult patients with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors.
Farxiga is specifically indicated to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes.
Farxiga is supplied as a tablet for oral administration. The recommended starting dose is 5 mg once daily, taken in the morning, with or without food. The dose can be increased to 10 mg once daily in patients tolerating Farxiga who require additional glycemic control. Renal function should be assessed before initiating Farxiga. Do not initiate Farxiga if eGFR is below 60 mL/min/1.73 m2. Farxiga should be discontinued if eGFR falls persistently below 60 mL/min/1.73 m2.
The FDA approval of Farxiga was based on monotherapy and combination studies, when combined with metformin, pioglitazone, glimepiride, sitagliptin (with or without metformin), or insulin (with or without other oral antidiabetic therapy).
Monotherapy Studies: Two placebo controlled studies were conducted in 840 treatment-naive subjects with inadequately controlled type II diabetes. One of these was a 24-week study in 558 subjects. Following a 2-week diet and exercise placebo lead-in period, 485 subjects with HbA1c >7% and <10% were randomized to Farxiga 5 mg or 10 mg once daily in either the morning (QAM, main cohort) or evening (QPM), or placebo. At Week 24, treatment with Farxiga 10 mg QAM provided significant improvements in HbA1c and FPG compared with placebo. Change from baseline in HbA1c for Farxiga: -.9 vs. placebo: -.2; change from baseline in FPG for Farxiga: -28.8 vs. placebo: -4.1.Combination Therapy Studies: Farxiga in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. Reductions in HbA1c were seen across subgroups including gender, age, race, duration of disease, and baseline BMI.
The FDA approval of Farxiga to reduce the risk of hospitalization for heart failure in adult patients with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors was based on the DECLARE–TIMI 58 trial. This was as a randomized, double-blind, multinational, placebo-controlled, phase 3 trial of dapagliflozin in patients with type 2 diabetes and established atherosclerotic cardiovascular disease or multiple risk factors for atherosclerotic cardiovascular disease. The trial evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE. In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group, but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%), which reflected a lower rate of hospitalization for heart failure there was no between-group difference in cardiovascular death.
The FDA approval of Farxiga to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes was based on the Phase III DAPA-HF trial, which showed Farxiga achieving a statistically significant and clinically meaningful reduction of CV death or hospitalization for heart failure, compared to placebo. Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% (absolute risk reduction [ARR] = 5% [event rate/100 patient years: 11.6 vs 15.6, respectively]) in patients with HFrEF. During the trial duration, one CV death or hospitalization for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga.
Adverse events associated with the use of Farxiga may include, but are not limited to, the following:
- female genital mycotic infections
- urinary tract infections
Mechanism of Action
Farxiga (dapagliflozin) is an inhibitor of Sodium-glucose cotransporter 2 (SGLT2). SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
For additional information regarding Farxiga or type II diabetes, please visit the Farxiga web page.