Table 2.
Patient Baseline Characteristics by Treatment Cohort in the Matched Analysis Sets
| Characteristic | Matched Set A |
Matched Set B |
||||
|---|---|---|---|---|---|---|
| Tolvaptan (n = 110) | Historical Controls (n = 110) | Standardized Mean Difference | Tolvaptan (n = 98) | Historical Controls (n = 98) | Standardized Mean Difference | |
| Age (y), n | 110 | 110 | 98 | 98 | ||
| Mean ± SD | 42.8 ± 10.1 | 42.9 ± 10.1 | −0.01 | 43.5 ± 9.1 | 43.5 ± 9.1 | −0.00 |
| Range | 19.4-69.8 | 19.3-69.6 | 23.2-67.3 | 21.9-67.0 | ||
| Sex, n (%) | 110 | 110 | 98 | 98 | ||
| Female | 44 (40.0) | 44 (40.0) | 0.00 | 37 (37.8) | 37 (37.8) | 0.00 |
| Race/ethnicity, n (%) | 110 | 110 | 98 | 98 | ||
| White | 72 (65.5) | 98 (89.1) | −0.59 | 69 (70.4) | 85 (86.7) | −0.41 |
| African American | 16 (14.5) | 4 (3.6) | 0.39 | 12 (12.2) | 4 (4.1) | 0.30 |
| Hispanic | 8 (7.3) | 4 (3.6) | 0.16 | 6 (6.1) | 5 (5.1) | 0.04 |
| Asian | 7 (6.4) | 2 (1.8) | 0.23 | 4 (4.1) | 1 (1.0) | 0.20 |
| Other | 7 (6.4) | 2 (1.8) | 0.23 | 7 (7.1) | 3 (3.1) | 0.19 |
| Age at ADPKD diagnosis (y), n | 110 | 110 | 98 | 98 | ||
| Mean ± SD | 35.0 ± 10.8 | 30.8 ± 11.2 | 0.38 | 35.6 ± 10.1 | 31.5 ± 10.8 | 0.40 |
| Range | 3.9-63.1 | 8.1-62.7 | 14.0-62.6 | 8.2-62.0 | ||
| CKD stage,a n (%) | 110 | 110 | 97 | 98 | ||
| G1 | 14 (12.7) | 14 (12.7) | 0.00 | 10 (10.3) | 10 (10.2) | 0.00 |
| G2 | 34 (30.9) | 34 (30.9) | 0.00 | 27 (27.8) | 35 (35.7) | −0.17 |
| G3a | 36 (32.7) | 36 (32.7) | 0.00 | 36 (37.1) | 20 (20.4) | 0.38 |
| G3b | 18 (16.4) | 18 (16.4) | 0.00 | 17 (17.5) | 25 (25.5) | −0.20 |
| G4 | 8 (7.3) | 8 (7.3) | 0.00 | 7 (7.2) | 7 (7.1) | 0.00 |
| G5 | 0 (0.0) | 0 (0.0) | n/a | 0 (0.0) | 1 (1.0) | −0.14 |
| Baseline eGFRb in mL/min/1.73 m2, n | 110 | 110 | 98 | 98 | ||
| Mean ± SD | 60.4 ± 26.4 | 63.2 ± 25.2 | −0.11 | 57.9 ± 22.8 | 57.9 ± 22.4 | 0.00 |
| Range | 9.9-142.1 | 20.3-131.2 | 9.9-121.4 | 12.8-122.0 | ||
| History of nephrolithiasis, n (%) | 110 | 110 | 98 | 98 | ||
| Yes | 12 (10.9) | 11 (10.0) | 0.03 | 12 (12.2) | 10 (10.2) | 0.06 |
| History of hypertension, n (%) | 110 | 110 | 98 | 98 | ||
| Yes | 79 (71.8) | 99 (90.0) | −0.48 | 76 (77.6) | 89 (90.8) | −0.37 |
Abbreviations: ADPKD, autosomal dominant polycystic kidney disease; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; SD, standard deviation.
a
Stage G1, ≥90 mL/min/1.73 m2; stage G2, 60 to < 90 mL/min/1.73 m2; stage G3a, 45 to < 60 mL/min/1.73 m2; stage G3b, 30 to < 45 mL/min/1.73 m2; stage G4, 15 to < 30 mL/min/1.73 m2; stage G5, < 15 mL/min/1.73 m2.
b
Because there were no baseline eGFR assessments for the tolvaptan patients, eGFR measured at month 1 (30-60 days after tolvaptan initiation) was considered as the baseline value.