Table 5.
Shift table for systolic and diastolic blood pressure during the double-blind treatment period (measured during office visits)
| Systolic and diastolic blood pressure and study drug | Post-baseline | Baseline | ||||
|---|---|---|---|---|---|---|
| Normal | Prehypertension | Hypertension stage 1 | Hypertension stage 2 | Total | ||
| Systolic blood pressure | ||||||
| Placebo | Normal | 36 (8.4) | 13 (3.0) | 0 | 0 | 49 |
| Prehypertension | 66 (15.3) | 149 (34.6) | 18 (4.2) | 2 (0.5) | 235 | |
| Hypertension stage 1 | 11 (2.6) | 65 (15.1) | 50 (11.6) | 5 (1.2) | 131 | |
| Hypertension stage 2 | 0 | 4 (0.9) | 10 (2.3) | 2 (0.5) | 16 | |
| Total | 113 | 231 | 78 | 9 | 431 | |
| No data | 2 | 5 | 3 | 1 | 11 | |
| Mirabegron 25 mg | Normal | 11 (4.9) | 6 (2.7) | 0 | 0 | 17 |
| Prehypertension | 33 (14.7) | 92 (41.1) | 11 (4.9) | 0 | 136 | |
| Hypertension stage 1 | 8 (3.6) | 31 (13.8) | 21 (9.4) | 2 (0.9) | 62 | |
| Hypertension stage 2 | 0 | 3 (1.3) | 3 (1.3) | 3 (1.3) | 9 | |
| Total | 52 | 132 | 35 | 5 | 224 | |
| No data | 1 | 1 | 0 | 0 | 2 | |
| Mirabegron 50 mg titration at week 4 | Normal | 22 (11.5) | 6 (3.1) | 0 | 0 | 28 |
| Prehypertension | 24 (12.5) | 38 (19.8) | 18 (9.4) | 0 | 80 | |
| Hypertension stage 1 | 13 (6.8) | 32 (16.7) | 27 (14.1) | 1 (0.5) | 73 | |
| Hypertension stage 2 | 0 | 2 (1.0) | 9 (4.7) | 0 | 11 | |
| Total | 59 | 78 | 54 | 1 | 192 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
| Mirabegron 50 mg titration at week 8 | Normal | 2 (7.4) | 1 (3.7) | 0 | 0 | 3 |
| Prehypertension | 3 (11.1) | 9 (33.3) | 1 (3.7) | 0 | 13 | |
| Hypertension stage 1 | 1 (3.7) | 2 (7.4) | 3 (11.1) | 2 (7.4) | 8 | |
| Hypertension stage 2 | 0 | 0 | 1 (3.7) | 2 (7.4) | 3 | |
| Total | 6 | 12 | 5 | 4 | 27 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
| Mirabegron 50 mg | Normal | 24 (11.0) | 7 (3.2) | 0 | 0 | 31 |
| Prehypertension | 27 (12.3) | 47 (21.5) | 19 (8.7) | 0 | 93 | |
| Hypertension stage 1 | 14 (6.4) | 34 (15.5) | 30 (13.7) | 3 (1.4) | 81 | |
| Hypertension stage 2 | 0 | 2 (0.9) | 10 (4.6) | 2 (0.9) | 14 | |
| Total | 65 | 90 | 59 | 5 | 219 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
| Diastolic blood pressure | ||||||
| Placebo | Normal | 217 (50.2) | 25 (5.8) | 2 (0.5) | 0 | 244 |
| Prehypertension | 78 (18.1) | 57 (13.2) | 7 (1.6) | 1 (0.2) | 143 | |
| Hypertension stage 1 | 18 (4.2) | 21 (4.9) | 5 (1.2) | 1 (0.2) | 45 | |
| Hypertension stage 2 | 0 | 0 | 0 | 0 | 0 | |
| Total | 313 | 103 | 14 | 2 | 432 | |
| No data | 8 | 2 | 0 | 0 | 10 | |
| Mirabegron 25 mg | Normal | 118 (52.7) | 20 (8.9) | 1 (0.4) | 0 | 139 |
| Prehypertension | 41 (18.3) | 20 (8.9) | 2 (0.9) | 1 (0.4) | 64 | |
| Hypertension stage 1 | 8 (3.6) | 8 (3.6) | 3 (1.3) | 0 | 19 | |
| Hypertension stage 2 | 0 | 1 (0.4) | 0 | 1 (0.4) | 2 | |
| Total | 167 | 49 | 6 | 2 | 224 | |
| No data | 1 | 1 | 0 | 0 | 2 | |
| Mirabegron 50 mg titration at week 4 | Normal | 75 (39.1) | 11 (5.7) | 0 | 0 | 86 |
| Prehypertension | 41 (21.4) | 35 (18.2) | 6 (3.1) | 1 (0.5) | 83 | |
| Hypertension stage 1 | 7 (3.6) | 10 (5.2) | 5 (2.6) | 0 | 22 | |
| Hypertension stage 2 | 0 | 0 | 1 (0.5) | 0 | 1 | |
| Total | 123 | 56 | 12 | 1 | 192 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
| Mirabegron 50 mg titration at week 8 | Normal | 10 (37.0) | 2 (7.4) | 0 | 0 | 12 |
| Prehypertension | 6 (22.2) | 7 (25.9) | 0 | 0 | 13 | |
| Hypertension stage 1 | 1 (3.7) | 1 (3.7) | 0 | 0 | 2 | |
| Hypertension stage 2 | 0 | 0 | 0 | 0 | 0 | |
| Total | 17 | 10 | 0 | 0 | 27 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
| Mirabegron 50 mg | Normal | 85 (38.8) | 13 (5.9) | 0 | 0 | 98 |
| Prehypertension | 47 (21.5) | 42 (19.2) | 6 (2.7) | 1 (0.5) | 96 | |
| Hypertension stage 1 | 8 (3.7) | 11 (5.0) | 5 (2.3) | 0 | 24 | |
| Hypertension stage 2 | 0 | 0 | 1 (0.5) | 0 | 1 | |
| Total | 140 | 66 | 12 | 1 | 219 | |
| No data | 0 | 0 | 0 | 0 | 0 | |
Data are presented as N (%)