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Comparative Study
. 2019 Feb;21(2):252-260.
doi: 10.1111/dom.13508. Epub 2018 Sep 21.

Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: A multicentre retrospective study

Gian Paolo Fadini  1 , Anna Solini  2 , Maria Laura Manca  3 , Giuseppe Penno  3 , Adriano Gatti  4 , Roberto Anichini  5 , Stefano Del Prato  3 , Angelo Avogaro  1 ; DARWIN-T2D Network
Affiliations
Comparative Study

Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: A multicentre retrospective study

Gian Paolo Fadini et al. Diabetes Obes Metab. 2019 Feb.

Abstract

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.

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Conflict of interest statement

Author contributions

Study design: G. P. F., A. S., S. D. P. and A. A. Data collection and analysis: G. P. F., A. S., A. G., R. A., G. P. and M. L. M. Manuscript writing: G. P. F., A. S. and A. A. Manuscript revision: A. S., S. D. P. and A. A. All authors approved the final version of the manuscript.

Figures

Figure 1
Figure 1
Study flowchart. T2D, type 2 diabetes; AER, albumin excretion rate; eGFR, estimated glomerular filtration rate
Figure 2
Figure 2
Change in AER during therapy with dapagliflozin or comparators. Values of AER at baseline (pre) and at follow‐up (post), along with the change from baseline (right panel), are shown for A, all patients, B, patients with baseline normoalbuminuria, C, microalbuminuria or D, macroalbuminuria. Columns' height in histograms indicate median value, whereas bars indicate the interquartile range. *P < 0.05 for the indicated comparison
See this image and copyright information in PMC

References

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