Table 4.
Patients meeting change from baseline criteria in vital signs by subpopulation (based on patients with three consecutive postbaseline values): past history of hypertension; hypertensive at screening; no hypertension at screening; β‐blocker user; non β‐blocker user
| Combination | Solifenacin 5 mg | Solifenacin 10 mg | |
|---|---|---|---|
| Past history of hypertension | n=17 | n=18 | n=17 |
| SBP: increase from baseline | |||
| ≥10 mm Hg | 0 | 2 (11.1%) | 0 |
| ≥15 mm Hg | 0 | 0 | 0 |
| ≥20 mm Hg | 0 | 0 | 0 |
| DBP: increase from baseline | |||
| ≥5 mm Hg | 0 | 0 | 2 (11.8%) |
| ≥10 mm Hg | 0 | 0 | 1 (5.9%) |
| ≥15 mm Hg | 0 | 0 | 0 |
| Pulse rate: increase from baseline | |||
| ≥5 bpm | 3 (17.6%) | 0 | 0 |
| ≥10 bpm | 2 (11.8%) | 0 | 0 |
| ≥15 bpm | 1 (5.9%) | 0 | 0 |
| Hypertensive at screening | n=255 | n=254 | n=248 |
| SBP: increase from baseline | |||
| ≥10 mm Hg | 11 (4.3%) | 10 (3.9%) | 10 (4.0%) |
| ≥15 mm Hg | 4 (1.6%) | 4 (1.6%) | 6 (2.4%) |
| ≥20 mm Hg | 2 (0.8%) | 1 (0.4%) | 3 (1.2%) |
| DBP: increase from baseline | |||
| ≥5 mm Hg | 22 (8.6%) | 23 (9.1%) | 21 (8.5%) |
| ≥10 mm Hg | 6 (2.4%) | 8 (3.1%) | 5 (2.0%) |
| ≥15 mm Hg | 0 | 2 (0.8%) | 1 (0.4%) |
| Pulse rate: increase from baseline | |||
| ≥5 bpm | 15 (5.9%) | 23 (9.1%) | 16 (6.5%) [n=247] |
| ≥10 bpm | 4 (1.6%) | 10 (3.9%) | 3 (1.2%) [n=247] |
| ≥15 bpm | 1 (0.4%) | 1 (0.4%) | 0 |
| No hypertension at screening | n=455 | n=461 | n=461 |
| SBP: increase from baseline | |||
| ≥10 mm Hg | 13 (2.9%) | 21 (4.6%) | 16 (3.5%) |
| ≥15 mm Hg | 9 (2.0%) | 9 (2.0%) | 3 (0.7%) |
| ≥20 mm Hg | 0 | 3 (0.7%) | 2 (0.4%) |
| DBP: increase from baseline | |||
| ≥5 mm Hg | 31 (6.8%) | 33 (7.2%) | 36 (7.8%) |
| ≥10 mm Hg | 9 (2.0%) | 10 (2.2%) | 9 (2.0%) |
| ≥15 mm Hg | 1 (0.2%) | 2 (0.4%) | 3 (0.7%) |
| Pulse rate: increase from baseline | |||
| ≥5 bpm | 32 (7.0%) | 30 (6.5%) | 43 (9.3%) |
| ≥10 bpm | 10 (2.2%) | 6 (1.3%) | 9 (0.2%) |
| ≥15 bpm | 4 (0.9%) | 1 (0.2%) | 1 (0.2%) |
| β‐blocker users | n=85 | n=92 | n=101 |
| SBP: increase from baseline | |||
| ≥10 mm Hg | 2 (2.4%) | 2 (2.2%) | 4 (4.0%) |
| ≥15 mm Hg | 1 (1.2%) | 2 (2.2%) | 1 (1.0%) |
| ≥20 mm Hg | 0 | 0 | 0 |
| DBP: increase from baseline | |||
| ≥5 mm Hg | 6 (7.1%) | 4 (4.3%) | 4 (4.0%) |
| ≥10 mm Hg | 2 (2.4%) | 1 (1.1%) | 1 (1.0%) |
| ≥15 mm Hg | 0 | 0 | 0 |
| Pulse rate: increase from baseline | |||
| ≥5 bpm | 4 (4.7%) | 6 (6.5%) | 10 (9.9%) |
| ≥10 bpm | 0 | 3 (3.3%) | 2 (2.0%) |
| ≥15 bpm | 0 | 1 (1.1%) | 0 |
| Non β‐blocker users | N=622 | N=622 | N=608 |
| SBP: increase from baseline | |||
| ≥10 mm Hg | 22 (3.5%) | 29 (4.7%) | 22 (3.6%) |
| ≥15 mm Hg | 12 (1.9%) | 11 (1.8%) | 8 (1.3%) |
| ≥20 mm Hg | 2 (0.3%) | 4 (0.6%) | 5 (0.8%) |
| DBP: increase from baseline | |||
| ≥5 mm Hg | 46 (7.4%) | 52 (8.4%) | 53 (8.7%) |
| ≥10 mm Hg | 13 (2.1%) | 17 (2.7%) | 13 (2.1%) |
| ≥15 mm Hg | 1 (0.2%) | 4 (0.6%) | 4 (0.7%) |
| Pulse rate: increase from baseline | |||
| ≥5 bpm | 43 (6.9%) | 47 (7.6%) | 49 (8.1%) [n=607] |
| ≥10 bpm | 14 (2.3%) | 13 (2.1%) | 10 (1.6%) [n=607] |
| ≥15 bpm | 5 (0.8%) | 1 (0.2%) | 1 (0.2%) [n=607] |
DBP, diastolic blood pressure; SBP, systolic blood pressure.