Table 2.
Relationship between annual changes in TKV and eGFR over 3 years and change in eHTKV-α from baseline at 1 year
| Tolvaptana | Placeboa | |||||||
|---|---|---|---|---|---|---|---|---|
| All (n = 812) |
Tolvaptan eHTKV-α quartile | P value | All (n = 453) |
|||||
| TQ1 (n = 203) |
TQ2 (n = 203) |
TQ3 (n = 203) |
TQ4 (n = 203) |
|||||
| Annual TKV change over 3 years | ||||||||
| Annual change (%/year) | n | 812 | 203 | 203 | 203 | 203 | 453 | |
| Median (IQR) | 1.03 (0.06) | 0.99 (0.04) | 1.01 (0.04) | 1.04 (0.04) | 1.07 (0.05) | < 0.001b | 1.06 (0.05) | |
| Q1, Q3 | 1.00, 1.06 | 0.96, 1.01 | 0.99, 1.04 | 1.02, 1.06 | 1.05, 1.10 | 1.03, 1.08 | ||
| Mean ± SD | 1.03 ± 0.06 | 0.99 ± 0.04 | 1.01 ± 0.03 | 1.04 ± 0.03 | 1.08 ± 0.06 | < 0.001c | 1.06 ± 0.05 | |
| Tolvaptan vs. placebo | LSM difference ± SE | − 0.027 ± 0.003 | − 0.070 ± 0.004 | − 0.043 ± 0.004 | − 0.018 ± 0.004 | 0.023 ± 0.004 | – | – |
| P valued | < 0.001 | < 0.001 | < 0.001 | < 0.001 | < 0.001 | – | – | |
| Mean difference (%) | − 2.535 | − 6.641 | − 4.043 | − 1.662 | 2.205 | – | – | |
| Annual eGFR change over 3 years | ||||||||
| Annual change (ml/min per 1.73 m2/year) | n | 812 | 203 | 203 | 203 | 203 | 453 | |
| Median (IQR) | − 2.52 (3.64) | − 2.08 (3.40) | − 2.05 (3.09) | − 2.92 (3.44) | − 3.27 (4.53) | < 0.001b | − 3.49 (4.36) | |
| Q1, Q3 | − 4.41, − 0.77 | − 3.77, − 0.37 | − 3.72, − 0.62 | − 4.75, − 1.31 | − 5.78, − 1.25 | − 5.83, − 1.47 | ||
| Mean ± SD | − 2.60 ± 3.42 | − 1.89 ± 2.67 | − 2.12 ± 3.54 | − 2.82 ± 3.17 | − 3.55 ± 3.92 | < 0.001c | − 3.64 ± 3.76 | |
| Tolvaptan vs. placebo | LSM difference ± SE | 1.047 ± 0.208 | 1.748 ± 0.292 | 1.523 ± 0.312 | 0.825 ± 0.303 | 0.093 ± 0.322 | – | – |
| P valued | < 0.001 | < 0.001 | < 0.001 | 0.007 | 0.8 | – | – | |
| Mean difference (%) | 28.749 | 47.999 | 41.803 | 22.656 | 2.540 | – | – | |
ANOVA, analysis of variance; eGFR, estimated glomerular filtration rate; eHTKV-α, estimated height-adjusted total kidney volume growth rate; IQR, interquartile range; LSM, least squares mean; SD, standard deviation; SE, standard error; 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
bP values were calculated using Pearson’s tests to determine whether there were significant correlations between change in eHTKV-α from baseline at 1 year and annual changes in TKV or eGFR over 3 years
cStatistical comparisons between tolvaptan eHTKV-α quartiles were based on ANOVA trend tests
dStatistical comparisons with the placebo group were based on ANOVA trend tests
Statistically significant values are indicated in bold