Aim: To evaluate the changes in renal endpoints in type 2 diabetes patients treated with dapagliflozin versus other glucose-lowering medications in routine clinical practice.
Materials and methods: DARWIN-T2D was a retrospective study conducted at 46 outpatient diabetes clinics in Italy. An automated software collected data on 17 285 patients who received dapagliflozin, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, or gliclazide, 6751 of whom had a follow-up visit. We analysed changes in albumin excretion rate (AER) and estimated glomerular filtration rate (eGFR).
Results: Patients who received dapagliflozin (n = 473) were younger, more obese, and had a poorer glucose control than those who received a comparator (n = 2973). After ~6 months, median (interquartile range) AER declined by 37%, from 19.5 (7.5-78.2) to 13.2 (6.5-45.0) mg/g (P < 0.0001) in the dapagliflozin group and did not change in the comparator group. After adjusting for confounders, therapy with dapagliflozin versus comparators was associated with an AER reduction of 26.4 ± 13.1 mg/g (P = 0.045), and eGFR (mL/min/1.73 m2 ) diminished by 1.1 ± 0.5 (P = 0.049) in the dapagliflozin group and by 0.6 ± 9.1 (P = 0.002) in the comparator group (P = 0.35 between groups). No patient treated with dapagliflozin versus four patients treated with comparators experienced a doubling of serum creatinine.
Conclusions: The antiproteinuric effect of dapagliflozin is confirmed here for the first time by real-world data. Despite a mild decline in eGFR, there was no evidence of clinically relevant worsening in renal function.
Keywords: antidiabetic drug; dapagliflozin; database research; diabetic nephropathy; type 2 diabetes.
© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.