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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.
AN SGLT2 INHIBITOR TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS
Head-to-Head vs Glipizide (a Sulfonylurea) + Metformin: 1-Year Data
Primary end point: With FARXIGA + metformin, reductions in A1C levels were noninferior to glipizide + metformin at 1 year1,2,a
aPatients on metformin ≥1500 mg per day were randomized following a 2-week placebo lead-in period to glipizide 5 mg or dapagliflozin 2.5 mg and were up-titrated over 18 weeks to optimal glycemic effect (FPG <110 mg/dL, <6.1 mmol/L) or to the highest dose level (up to glipizide 20 mg and FARXIGA 10 mg) as tolerated by patients. At the end of the titration period, 87% of patients treated with FARXIGA had been titrated to the maximum study dose (10 mg) vs 73% treated with glipizide (20 mg). Dapagliflozin 2.5 mg is not an FDA-approved dose.
BL=baseline.
Values are last observation carried forward and represent adjusted mean change from baseline.
Secondary end point: Significant mean weight reduction from baseline with FARXIGA + metformin vs glipizide + metformin at 1 year1,2
bP<0.0001.
BL=baseline.
Values are last observation carried forward and represent adjusted mean change from baseline.
FARXIGA is not indicated for weight loss.
*Weight reduction was a secondary end point.
A secondary end point: Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 1 year1-3
cP<0.0001 vs glipizide + metformin.
BL=baseline.
Values are last observation carried forward.
FARXIGA is not indicated for the treatment of hypertension.
†Blood pressure reduction was a secondary end point.
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.
Head-to-Head vs Glipizide (a Sulfonylurea) + Metformin: 1-Year Data
Randomized, 1-year, double-blind, parallel-group, active-controlled, multicenter, noninferiority, phase 3 study
‡Patients received dapagliflozin 2.5 mg or glipizide 5 mg and were up-titrated to optimal glycemic effect (FPG <110 mg/dL) or to the highest dose level (up to FARXIGA 10 mg and glipizide 20 mg) as tolerated by patients. Metformin dose was ≥1500 mg/day. 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 plus metformin vs glipizide plus metformin in adult patients with type 2 diabetes whose A1C is inadequately controlled on metformin monotherapy.
1 year
Adult patients with type 2 diabetes who had inadequate glycemic control (A1C >6.5% and ≤10.0%) and had a BMI of ≤45 kg/m2. Patients with systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg were excluded.
FARXIGA was up-titrated to a maximum dose of 10 mg. Glipizide was up-titrated to a maximum dose of 20 mg. Up-titration occurred over 18 weeks, after which doses were kept constant unless down-titration was required to prevent hypoglycemia.
FARXIGA tablet shown is not actual size.
Change in A1C from baseline at 1 year
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:
