Table 4.
Proportion of patients on various treatment regimens at the end of the TEMPO 3:4 and 4:4 trials: Influence of aquaretic adverse events
| TEMPO 3:4 | n (%) |
|---|---|
| No AAE | 167 (100) |
| 45/15 mg | 19 (11) |
| 60/30 mg | 18 (11) |
| 90/30 mg | 130 (78) |
| AC | 573 (100) |
| 45/15 mg | 157 (27) |
| 60/30 mg | 145 (25) |
| 90/30 mg | 271 (47) |
| TEMPO 4:4 | n (%) |
|---|---|
| No AAE | 74 (100) |
| 45/15 mg | 16 (22) |
| 60/30 mg | 12 (16) |
| 90/30 mg | 46 (62) |
| AC | 182 (100) |
| 45/15 mg | 71 (39) |
| 60/30 mg | 34 (19) |
| 90/30 mg | 77 (42) |
AAE, aquaretic adverse event; AC, aquaretic adverse event continued; No AAE, no aquaretic adverse event; TEMPO, Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes.
Proportion of patients maintaining the target dose of 90/30 mg, No AAE versus AC: TEMPO 3:4, 130 of 167 versus 271 of 573, P < 0.0001; TEMPO 4:4, 46 of 74 versus 77 of 182, P = 0.0056, respectively).