Table 4.
Percentage of Subjects With Urine Osmolality <300 mOsm/kg and Percentage of Subjects Who Tolerated Titrated Split‐Dose Regimens of Tolvaptan in Subjects With ADPKD in Trial 250
| Week of Treatment and Dose | ||||||
|---|---|---|---|---|---|---|
| Day 0 | Week1 | Week 2 | Week 3 | Week 4 | ||
| Baseline | 30/15 mg | 45/15 mg | 60/30 mg | 45/15 mg | 90/30 mg | |
| (n = 45)a | (n = 45)a | (n = 43)a | (n = 43)a | (n = 14)a | (n = 27)a | |
| Time of day | ||||||
| Prior to first dose | 24 | 64 | 70 | 77 | 42 | 85 |
| Prior to second dose | 33 | 84 | 97.7 | 97.7 | 92.9 | 100 |
| Prior to bedtime | 38 | 91.1 | 93 | 97.7 | 91.7 | 100 |
| Subjects tolerating, % | ||||||
| Dose after 1 week | – | 96 (44/46) | 100 (44/44) | 64 (28/44) | – | 75 (21/28) |
Subjects tolerating is based on the proportion of subjects having a “yes” response to the following query on their tolerability of the tolvaptan dose: “Could you tolerate taking this dose of tolvaptan for the rest of your life, please answer only yes or no?”
a
Number of subjects with urine osmoality sample at any time of day.