CLINICAL STUDIES – The latest FDA approval was based on the results of a double-blind trial (DAPA-CKD) in 4304 patients with CKD (eGFR 25-75 mL/min/1.73 m²; urine albumin-to-creatinine ratio 200-5000 mg/g) with or without type 2 diabetes or cardiovascular disease. Patients were randomized to receive dapagliflozin 10 mg or placebo once daily in addition to standard treatment. Over a median of 2.4 years, the incidence of the primary endpoint, a composite of sustained decline in eGFR ≥50%, end-stage renal disease, or renal or cardio vascular death, was significantly lower with dapagliflozin than with placebo (see Table 2). The beneficial effects of dapagliflozin were similar in patients with and without type 2 diabetes or cardiovascular disease.1,2

ADVERSE EFFECTS – SGLT2 inhibitors, including dapagliflozin, can increase the risk of genital mycotic infection, urinary tract infection, volume depletion, hypotension, and ketoacidosis in patients with type 2 diabetes. In DAPA-CKD, rates of adverse events were similar in patients with and without type 2 diabetes or cardiovascular disease.

DOSAGE AND COST – The recommended dosage of dapagliflozin for the new indication is 10 mg once daily. The wholesale acquisition cost for 30 days' treatment with Farxiga is $532.80.3