Long-term observation of estimated fluid volume reduction after the initiation of ipragliflozin in patients with type 2 diabetes mellitus: a sub-analysis from a randomized controlled trial (PROTECT)

Table 4 Changes in the parameters incorporated into the formulas for calculating the ePV and eEV*

Variables	Ipragliflozin (N = 232)		Control (N = 232)		Group difference^† (95% CI)	P-value
Variables	n	Mean ± SD	n	Mean ± SD	Group difference^† (95% CI)	P-value
Hemoglobin, g/dL
Baseline	224	14.05 ± 1.54	220	14.05 ± 1.50
Change from baseline to 12 months	179	0.79 ± 0.78	191	− 0.10 ± 0.82	0.83 (0.65 to 1.00)	< 0.001
Change from baseline to 24 months	206	0.77 ± 1.02	210	− 0.13 ± 1.04	0.87 (0.70 to 1.04)	< 0.001
Hematocrit, %
Baseline	224	41.79 ± 4.08	220	41.90 ± 4.07
Change from baseline to 12 months	179	2.69 ± 2.36	191	− 0.32 ± 2.53	2.85 (2.32 to 3.38)	< 0.001
Change from baseline to 24 months	206	2.55 ± 2.94	210	− 0.46 ± 3.05	2.91 (2.40 to 3.42)	< 0.001
Body weight, kg
Baseline	231	68.82 ± 13.17	232	70.26 ± 15.61
Change from baseline to 12 months	194	− 2.24 ± 3.23	202	− 0.01 ± 2.86	− 2.14 (− 2.82 to − 1.47)	< 0.001
Change from baseline to 24 months	219	− 2.69 ± 3.75	222	− 0.77 ± 3.97	− 1.91 (− 2.56 to − 1.26)	< 0.001

CI: confidence interval; eEV: estimated extracellular volume; ePV: estimated plasma volume; SD: standard deviation
*Height was excluded, because the eEV at each timepoint was calculated using the height at baseline
^†Estimated by a longitudinal mixed-effects model for repeated measures

ISSN: 1758-5996