![]() ![]() A separation of the curves as a marker for effect in the lowest UACR category (≤15 mg/g) was seen after 36 months ( P = 0.0140 at 36 months, P 300 mg/g), after a large decrease in mean UACR during the first 6 months of treatment, the mean UACR remained stable to decreased during 48 months of treatment with dapagliflozin ( Fig. At 6 months, the dapagliflozin arm had a statistically significant lower mean UACR compared with placebo in all UACR baseline subgroups ( P = 0.0033 for UACR ≤15 mg/g and P 15 mg/g was lower in the dapagliflozin arm than in the placebo arm ( Fig. Statistical AnalysisĬhange in the geometric mean in UACR over time by treatment arm is presented according to the four UACR baseline subgroups ≤15, >15 to 300 mg/g ( Fig. Confirmed sustained change in the categorical UACR was defined as a change in the UACR categories in two consecutive tests done according to the schedule for UACR testing at the central laboratory, as mentioned above. A sensitivity analysis was performed assigning below detectable measures of urinary albumin to UACR = 3.5 mg/g (the midpoint of the range). For calculation of the continuous change in UACR over time and avoid bias due to the date of enrollment, all measured values of urine albumin <7.0 mg/L were recognized as below the detectable level and assigned a value of 7 mg/g UACR for continuous analysis. Due to a change in the assay used in the central laboratory to measure urinary albumin, the lowest detectable level of albumin was modified during the trial from urine albumin <3.0 mg/L since the initiation of the trial on 25 April 2013 until 30 April 2017, and then <7.0 mg/L until the end of the trial on 18 September 2018. Patients with baseline urinary albumin below the laboratory’s lowest detectable level were recog-nized as a distinct UACR category and grouped together with patients with UACR ≤15 mg/g. Participants were divided into prespecified subgroups according to their baseline eGFR (eGFR ≥90, 15 to 300 mg/g) ( 19). The renal-specific outcome included all the components of the cardiorenal outcome except CV death ( 3). The cardiorenal outcome was defined as time to first event of a composite of sustained confirmed decrease in eGFR by at least 40% (as confirmed by two tests at the central laboratory at least 4 weeks apart) to <60 mL/min/1.73 m 2, ESKD (defined as dialysis for ≥90 days, kidney transplantation, or sustained eGFR of <15 mL/min/1.73 m 2), or CV or renal death. Since the trial met only one of its dual primary outcomes for superiority, all other analyses of additional outcomes should only be considered as hypothesis generating. The primary end points of the trial, major adverse cardiovascular events (MACE), a composite of CV death, myocardial infarction, or ischemic stroke, achieved noninferiority, and a composite of CV death or hospital admission for heart failure achieved superiority ( 3). Participants were randomly assigned in a double-blinded manner to once-daily dapagliflozin 10 mg or matching placebo (1:1). ![]()
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