Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic …

VE Torres, AB Chapman, O Devuyst… - Nephrology Dialysis …, 2017 - academic.oup.com
VE Torres, AB Chapman, O Devuyst, RT Gansevoort, RD Perrone, A Dandurand, J Ouyang…
Nephrology Dialysis Transplantation, 2017academic.oup.com
Caucasian 535 (96.1) 302 (96.2) Black or African American 9 (1.6) 2 (0.6) Asian 3 (0.5) 2
(0.6) Other 10 (1.8) 8 (2.5) Height, cm [mean (SD)] 174.6 (10.4) 173.9 (9.8) 0.32 174.8 (10.3)
174.1 (9.7) 0.35 Weight, kg [mean (SD)] 80.5 (17.7) 79.2 (17.2) 0.30 82.6 (18.4) 81.0 (17.3)
0.23 Age at diagnosis, years [mean (SD)] 27.1 (9.3) 27.2 (9.6) 0.76 TKV, mL [median (IQR)]
1498 (977) 1468 (751) 0.60 1706 (1199) 1835 (1162) 0.05 TKV,% change from TEMPO 3: 4
BL 15.8 (17.0) 23.8 (16.9)< 0.0001 eGFR, mL/min/1.73 m2 [mean (SD)] 82.2 (20.6) 83.5 …
Caucasian 535 (96.1) 302 (96.2) Black or African American 9 (1.6) 2 (0.6) Asian 3 (0.5) 2 (0.6) Other 10 (1.8) 8 (2.5) Height, cm [mean (SD)] 174.6 (10.4) 173.9 (9.8) 0.32 174.8 (10.3) 174.1 (9.7) 0.35 Weight, kg [mean (SD)] 80.5 (17.7) 79.2 (17.2) 0.30 82.6 (18.4) 81.0 (17.3) 0.23 Age at diagnosis, years [mean (SD)] 27.1 (9.3) 27.2 (9.6) 0.76 TKV, mL [median (IQR)] 1498 (977) 1468 (751) 0.60 1706 (1199) 1835 (1162) 0.05 TKV,% change from TEMPO 3: 4 BL 15.8 (17.0) 23.8 (16.9)< 0.0001 eGFR, mL/min/1.73 m2 [mean (SD)] 82.2 (20.6) 83.5 (22.6) 0.59 72.3 (24.5) 70.4 (25.0) 0.38 eGFR, change from TEMPO 3: 4 BL [mean (SD)] À8. 1 (À10. 3) À10. 6 (À13. 71) 0.003 Blood pressure, mmHg (SD)
Diastolic 82.6 (9.1) 82.7 (9.0) 0.92 80.8 (8.6) 81.1 (8.8) 0.41 Systolic 128.6 (13.2) 128.8 (13.2) 0.86 126.6 (12.4) 127.0 (12.1) 0.68 ACE/ARB use,%(n) 72.0 (401) 71.0 (223) 0.76 81.1 (452) 78.7 (247) 0.38 ACR, mg/mmol (SD) 6.41 (11.75) 6.65 (16.31) 0.85 6.07 (12.46) 7.69 (19.27) 0.04 Copeptina, pmol/L (SD) 8.7 (10.0) 10.9 (25.5) 0.70 Days between TEMPO 3: 4 and 4: 4, days [mean, median (range)]
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