Dapagliflozin Evaluated in Patients With T2D and Moderate Renal Impairment
AstraZeneca announced new data evaluating the safety and efficacy of dapagliflozin (Farxiga) in patients with type 2 diabetes (T2D) with moderate renal impairment. Full findings were presented at the Endocrine Society annual meeting (ENDO).
The Phase 3 DERIVE trial (N=321) randomized patients with T2D (HbA1c 7–11%) and stage 3A chronic kidney disease (CKD) with eGFR 45–59mL/min/1.73m2 to either dapagliflozin 10mg or placebo for 24 weeks. Compared to placebo, treatment with dapagliflozin resulted in a significant decrease in mean HbA1c (-0.37% vs -0.03%; difference -0.34%; P<0.001) and mean body weight (-3.17kg vs -1.92kg; difference -1.25kg; P<0.001) from baseline to Week 24.
The mean fasting plasma glucose was also significantly lowered with dapagliflozin vs placebo (-21.46mg/dL vs -4.87mg/dL) as was mean systolic blood pressure (-4.8mmHg vs -1.7mmHg) from baseline to Week 24.
Regarding safety, dapagliflozin lowered the mean eGFR by -3.2mL/min/1.73m2 vs -0.63mL/min/1.73m2 in placebo. Adverse events occurred in 41.9% of dapagliflozin-treated patients vs 47.8% of placebo patients. Urinary tract infection and pollakiuria were the most common treatment-related events.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. It is available as 5mg and 10mg strength tablets.
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