Table 1.
Patient baseline demographics and clinical parameters by tolvaptan eHTKV-α quartile
| Tolvaptana | Placeboa | |||||||
|---|---|---|---|---|---|---|---|---|
| All (n = 812) |
Tolvaptan eHTKV-α quartile | P valueb | All (n = 453) |
P valuec | ||||
| TQ1 (n = 203) |
TQ2 (n = 203) |
TQ3 (n = 203) |
TQ4 (n = 203) |
|||||
| Male sex, n (%) | 423 (52.1) | 72 (35.5) | 98 (48.3) | 112 (55.2) | 141 (69.5) | < 0.001 | 234 (51.7) | 0.9 |
| Age (years), mean ± SD | 38.8 ± 6.9 | 38.8 ± 6.9 | 39.1 ± 7.0 | 38.9 ± 6.9 | 38.3 ± 7.0 | 0.6 | 39.1 ± 7.1 | 0.5 |
| TKV parameters | ||||||||
| TKV (ml), n | 812 | 203 | 203 | 203 | 203 | 453 | ||
| Mean ± SD | 1717.3 ± 912.4 | 1415.9 ± 579.1 | 1789.7 ± 820.7 | 1830.1 ± 992.5 | 1833.7 ± 1107.1 | < 0.001 | 1677.0 ± 885.2 | 0.4 |
| HtTKV (ml/m), n | 812 | 203 | 203 | 203 | 203 | 453 | ||
| Mean ± SD | 986.6 ± 511.6 | 827.2 ± 326.1 | 1026.7 ± 450.6 | 1048.2 ± 558.6 | 1044.5 ± 628.7 | < 0.001 | 963.5 ± 490.0 | 0.4 |
| eHTKV-α (%/year), n | 812 | 203 | 203 | 203 | 203 | 453 | ||
| Mean ± SD | 5.2 ± 1.5 | 4.8 ± 1.5 | 5.3 ± 1.4 | 5.3 ± 1.6 | 5.3 ± 1.5 | 0.001 | 5.1 ± 1.6 | 0.6 |
| Change in eHTKV-α from baseline at 1 year (%), n | 812 | 203 | 203 | 203 | 203 | 453 | ||
| Range | < − 6.3 | − 6.3 to < − 3.7 | − 3.7 to < − 1.2 | ≥ − 1.2 | ||||
| Mean ± SD | − 3.7 ± 4.4 | − 9.2 ± 2.6 | − 4.9 ± 0.8 | − 2.4 ± 0.7 | 1.7 ± 2.9 | < 0.001 | − 0.5 ± 4.6 | < 0.001 |
| Kidney function parameters | ||||||||
| Serum creatinine (mg/dl), n | 809 | 203 | 202 | 201 | 203 | 451 | ||
| Mean ± SD | 1.1 ± 0.3 | 1.0 ± 0.3 | 1.0 ± 0.3 | 1.1 ± 0.3 | 1.1 ± 0.3 | < 0.001 | 1.0 ± 0.3 | 0.5 |
| eGFR (ml/min per 1.73 m2), n | 809 | 203 | 202 | 201 | 203 | 451 | ||
| Mean ± SD | 80.7 ± 20.9 | 83.8 ± 19.3 | 81.2 ± 20.1 | 78.0 ± 20.9 | 79.6 ± 22.7 | 0.04 | 81.7 ± 22.8 | 0.4 |
| Urine osmolality | ||||||||
| At baseline (mOsm/kg), n | 797 | 197 | 199 | 199 | 202 | 448 | ||
| Mean ± SD | 489.1 ± 174.7 | 522.5 ± 169.5 | 486.2 ± 166.1 | 469.6 ± 177.3 | 478.4 ± 182.0 | 0.01 | 507.1 ± 188.0 | 0.09 |
| Change from baseline at week 3 (mOsm/Kg), n | 778 | 194 | 191 | 195 | 198 | 441 | ||
| Mean ± SD | −296.6 ± 186.8 | −326.5 ± 185.7 | −284.7 ± 174.5 | −275.1 ± 197.5 | −299.9 ± 185.8 | 0.04 | −63.4 ± 180.2 | < 0.001 |
| Plasma copeptin | ||||||||
| At baseline (pmol/l), n | 679 | 173 | 176 | 170 | 160 | 434 | ||
| Mean ± SD | 8.5 ± 10.8 | 8.7 ± 13.4 | 9.3 ± 13.7 | 7.8 ± 6.4 | 8.3 ± 7.0 | 0.6 | 10.4 ± 22.0 | 0.09 |
| Change from baseline at week 3 (pmol/l), n | 590 | 156 | 147 | 149 | 138 | 391 | ||
| Mean ± SD | 15.2 ± 16.2 | 16.8 ± 22.6 | 14.3 ± 16.5 | 16.0 ± 13.3 | 13.5 ± 7.5 | 0.3 | − 1.9 ± 19.1 | < 0.001 |
| BP parameters | ||||||||
| Hypertension at age < 35 years, n | 654 | 151 | 172 | 165 | 166 | 363 | ||
| n (%) | 413 (63.1) | 87 (57.6) | 107 (62.2) | 105 (63.6) | 114 (68.7) | 0.04 | 210 (57.9) | 0.1 |
ANOVA, analysis of variance; BP, blood pressure; eGFR, estimated glomerular filtration rate; eHTKV-α, estimated height-adjusted total kidney volume growth rate; HtTKV, height-adjusted total kidney volume; SD, standard deviation; TKV, total kidney volume; TQ, tolvaptan eHTKV-α quartile
aAnalyses included all patients in TEMPO 3:4 with TKV data available to calculate eHTKV-α at baseline and year 1; tolvaptan-assigned patients were further divided into quartiles (TQ1–TQ4) based on percent change in eHTKV-α from baseline at 1 year
bStatistical comparisons between tolvaptan eHTKV-α quartiles were based on Cochran Armitage tests for categorical variables and ANOVA trend tests for continuous variables
cStatistical comparisons between the overall tolvaptan and placebo treatment groups were based on Chi-squared tests for categorical variables and two-sample t-tests for continuous variables
Data are for parameters recorded at baseline, unless otherwise specified. Statistically significant values are indicated in bold