@article{discovery10140531,
           month = {November},
            note = {This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com.},
            year = {2021},
           title = {Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: A prespecified analysis of the DAPA-CKD trial},
         journal = {Nephrology Dialysis Transplantation},
        keywords = {DAPA-CKD, dapagliflozin, eGFR slope, focal segmental glomerulosclerosis},
        abstract = {BACKGROUND: Despite renin-angiotensin-aldosterone-system blockade and immunosuppressive treatment, focal segmental glomerulosclerosis (FSGS) often progresses to kidney failure. The objective of this pre-specified analysis of DAPA-CKD was to assess efficacy and safety of dapagliflozin in a small subgroup participants with FSGS confirmed by kidney biopsy. METHODS: In DAPA-CKD, patients with estimated glomerular filtration rate (eGFR) 25-75�mL/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) 200-5000�mg/g (22.6-565�mg/mol) were randomised to dapagliflozin 10mg�once-daily or placebo as an adjunct to standard care, and followed for median 2.4 years. The primary composite endpoint was sustained eGFR decline�{$\ge$}�50\%, end-stage kidney disease (ESKD), or kidney or cardiovascular death. The endpoint of interest for this analysis was eGFR slope (acute effects from baseline to Week 2 and chronic effects from Week 2 to end of treatment). RESULTS: Of 104 participants with biopsy-confirmed FSGS, 45 were randomised to dapagliflozin and 59 to placebo. Mean (SD) age was 54.0 (14.3) years, mean eGFR 41.9 (11.5) mL/min/1.73m2 and median (IQR) UACR 1248 (749-2211) mg/g. The primary outcome occurred in 4 (8.9\%) and 7 (11.9\%) participants randomised to dapagliflozin and placebo, respectively (HR 0.62, 95\%CI 0.17-2.17). Dapagliflozin led to a larger acute reduction (SE) in eGFR compared to placebo (-4.5 [95\% CI�-�5.9--3.1] vs�-�0.9 [-2.1-0.4] mL/min/1.73m2 per 2 wks). Thereafter, mean rates of chronic eGFR decline with dapagliflozin and placebo were�-�1.9 (-3.0--0.9) and�-�4.0 (-4.9--3.0) mL/min/1.73m2/year, respectively (difference 2.0 [95\%CI 0.6-3.5] mL/min/1.73m2/year). Adverse events leading to study drug discontinuation were similar in both groups; there were fewer serious adverse events with dapagliflozin. CONCLUSION: Among DAPA-CKD participants with FSGS, dapagliflozin reduced the rate of chronic decline of eGFR compared to placebo, although this difference was not statistically significant.},
          author = {Wheeler, DC and Jongs, N and Stefansson, BV and Chertow, GM and Greene, T and Hou, FF and Langkilde, AM and McMurray, JJV and Rossing, P and Nowicki, M and Wittmann, I and Correa-Rotter, R and Sj{\"o}str{\"o}m, CD and Toto, RD and Heerspink, HJL and DAPA-CKD Trial Committees {and} Investigators, {}},
             url = {https://doi.org/10.1093/ndt/gfab335}
}