Learn more about AstraZeneca’s Commitment to the Science at the virtual American Heart Association (AHA) Scientific Sessions 2020, November 13th-17th.
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
AN SGLT2 INHIBITOR TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS
FARXIGA as Add-On to Glimepiride (a Sulfonylurea)
Primary end point: Mean reduction in A1C levels with FARXIGA + glimepiride at 24 weeks1,2
aP<0.0001 vs placebo + glimepiride.
BL=baseline.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.
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.
Secondary end point: Mean weight reduction with FARXIGA + glimepiride at 24 weeks1,2
bP<0.0001 vs placebo + glimepiride.
BL=baseline.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.
FARXIGA is not indicated for weight loss.
*Weight reduction was a secondary end point.
FARXIGA as Add-On to Glimepiride (a Sulfonylurea)
Randomized, double-blind, multicenter, placebo-controlled, 24-week, phase 3 trial
†Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.
Evaluate the efficacy and safety of FARXIGA in adult patients with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.
Change in A1C from baseline at Week 24
24 weeks
Patients were ≥18 years of age with type 2 diabetes with an A1C of ≥7.0% and ≤10.0%, BMI ≤45 kg/m2, FPG level of ≤270.3 mg/dL, and a fasting C-peptide ≥1.0 ng/mL. Patients were given a stable dose of sulfonylurea (≥1/2 maximum recommended dose) for ≥8 weeks prior to enrollment.
Patients on at least half the maximum recommended dose of sulfonylurea as monotherapy for at least 8 weeks lead-in were randomized to dapagliflozin 2.5 mg,† FARXIGA 5 mg, FARXIGA 10 mg, or placebo in addition to glimepiride 4 mg per day. Down-titration of glimepiride to 2 mg or 0 mg was allowed for hypoglycemia during the treatment period; no up-titration of glimepiride was allowed.
†Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented. FARXIGA tablets shown are not actual sizes.
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
References:
Reference:
Most common (≥5%) and occurring more frequently than comparator in clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%)
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Please read US Full Prescribing Information and Medication Guide for BYDUREON, including Boxed WARNING.
References:
FARXIGA is indicated: