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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.
IN ADULTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON METFORMIN
FARXIGA 10 mg in Combination With Exenatide
Primary end point: Mean reduction in A1C levels at 28 weeks1-3
aP=0.001 vs FARXIGA + metformin and P=0.012 vs exenatide + metformin.
A1C=glycated hemoglobin; BL=baseline; QD=once daily.
Study not powered to compare individual treatment arms of FARXIGA + metformin or exenatide + metformin.
Recommended starting dose for patients taking FARXIGA is one 5 mg tablet QD.
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Secondary end point: Mean weight reduction at 28 weeks3
bP<0.001 vs FARXIGA + metformin and P<0.001 vs exenatide + metformin.
BL=baseline.
Study not powered to compare individual treatment arms of FARXIGA + metformin or exenatide + metformin.
FARXIGA and exenatide are not indicated for weight loss.
*Weight reduction was a secondary end point.
Reductions in fasting plasma glucose (FPG) and 2-hour postprandial glucose (PPG) were greater in patients given FARXIGA + exenatide combination than in those on either drug alone (secondary end points)1,2
Evaluate the efficacy and safety of FARXIGA (an SGLT2i) in combination with exenatide (a GLP-1 RA) to FARXIGA alone and exenatide alone, as add-on to metformin.
Change in A1C from baseline
Change in weight, FPG and PPG
28 weeks
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: