Table 4.
Summary of changes from baseline to Final Visit in blood pressure and pulse rate
| Placebo (n = 1380) | Mirabegron 25 mg (n = 432) | Mirabegron 50 mg (n = 1375) | Mirabegron 100 mg (n = 929) | Tolterodine ER 4 mg (n = 495) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AM | PM | AM | PM | AM | PM | AM | PM | AM | PM | |
| Blood pressure (mmHg) | ||||||||||
| SBP | ||||||||||
| N | 1329 | 1326 | 410 | 410 | 1327 | 1327 | 891 | 890 | 476 | 476 |
| Baseline, mean (SE) | 125.9 (0.47) | 125.0 (0.41) | 129.2 (0.81) | 129.0 (0.71) | 126.4 (0.47) | 125.6 (0.43) | 125.0 (0.55) | 123.7 (0.49) | 128.2 (0.75) | 127.4 (0.64) |
| Final Visit, mean (SE) | 126.2 (0.45) | 125.7 (0.41) | 128.8 (0.75) | 128.3 (0.67) | 127.2 (0.46) | 126.6 (0.41) | 125.6 (0.51) | 125.2 (0.46) | 128.4 (0.70) | 127.9 (0.63) |
| Adjusted change from baseline, mean (SE), (95% CI)† | 0.2 (0.25), (−0.3, 0.7) | 0.6 (0.25), (0.1, 1.1) | −0.3 (0.52), (−1.3, 0.7) | −0.5 (0.53), (−1.5, 0.6) | 0.8 (0.25), (0.3, 1.3) | 1.1 (0.25), (0.6, 1.6) | 0.6 (0.32), (−0.0, 1.2) | 1.4 (0.33), (0.8, 2.1) | 0.1 (0.45), (−0.8, 1.0) | 0.5 (0.46), (−0.4, 1.4) |
| Difference vs. placebo, mean (SE), (95% CI)‡ | – | – | −0.5 (0.57), (−1.6, 0.6) | −1.0 (0.58), (−2.2, 0.1) | 0.6 (0.35), (−0.1, 1.3) | 0.5 (0.36), (−0.2, 1.2) | 0.4 (0.41), (−0.4, 1.2) | 0.9 (0.42), (0.1, 1.7) | −0.1 (0.52), (−1.1, 1.0) | −0.0 (0.53), (−1.1, 1.0) |
| DBP | ||||||||||
| N | 1329 | 1326 | 410 | 410 | 1327 | 1327 | 890 | 890 | 476 | 476 |
| Baseline, mean (SE) | 77.1 (0.26) | 75.3 (0.23) | 78.2 (0.48) | 76.1 (0.46) | 77.2 (0.25) | 75.4 (0.24) | 77.4 (0.30) | 75.3 (0.28) | 76.8 (0.40) | 75.4 (0.38) |
| Final Visit, mean (SE) | 77.2 (0.25) | 75.7 (0.24) | 77.6 (0.43) | 75.7 (0.42) | 77.6 (0.24) | 76.2 (0.24) | 77.7 (0.28) | 76.3 (0.28) | 77.7 (0.39) | 76.6 (0.36) |
| Adjusted change from baseline, mean (SE), (95% CI)† | 0.0 (0.16), (−0.3, 0.3) | 0.4 (0.16), (0.1, 0.7) | −0.1 (0.33), (−0.8, 0.5) | 0.1 (0.34), (−0.6, 0.7) | 0.4 (0.16), (0.1, 0.7) | 0.7 (0.16), (0.4, 1.1) | 0.2 (0.21), (−0.2, 0.6) | 0.9 (0.21), (0.5, 1.3) | 0.8 (0.29), (0.2, 1.3) | 1.4 (0.30), (0.8, 2.0) |
| Difference vs. placebo, mean (SE), (95% CI)‡ | – | – | −0.1 (0.37), (−0.9, 0.6) | −0.3 (0.37), (−1.0, 0.4) | 0.4 (0.22), (−0.1, 0.8) | 0.4 (0.23), (−0.1, 0.8) | 0.2 (0.26), (−0.3, 0.7) | 0.5 (0.27), (−0.0, 1.0) | 0.7 (0.33), (0.1, 1.4) | 1.0 (0.34), (0.4, 1.7) |
| Pulse rate (bpm) | ||||||||||
| N | 1329 | 1326 | 410 | 410 | 1327 | 1327 | 891 | 890 | 476 | 476 |
| Baseline, mean (SE) | 70.5 (0.28) | 75.3 (0.29) | 71.0 (0.50) | 75.5 (0.51) | 70.4 (0.28) | 74.9 (0.28) | 70.4 (0.34) | 74.4 (0.34) | 69.8 (0.44) | 73.9 (0.45) |
| Final Visit, mean (SE) | 70.9 (0.29) | 74.7 (0.29) | 71.7 (0.52) | 75.3 (0.53) | 71.8 (0.29) | 75.5 (0.28) | 72.9 (0.34) | 76.5 (0.34) | 71.4 (0.44) | 76.0 (0.45) |
| Adjusted change from baseline, mean (SE), (95% CI)† | 0.4 (0.17), (0.1, 0.8) | −0.4 (0.18), (−0.8, −0.1) | 1.3 (0.36), (0.6, 2.0) | 0.2 (0.37), (−0.6, 0.9) | 1.4 (0.17), (1.1, 1.8) | 0.6 (0.18), (0.2, 0.9) | 2.3 (0.22), (1.9, 2.8) | 1.9 (0.23), (1.4, 2.3) | 1.4 (0.31), (0.8, 2.0) | 1.7 (0.32), (1.1, 2.3) |
| Difference vs. placebo, mean (SE), (95% CI)‡ | – | – | 0.9 (0.40), (0.1, 1.6) | 0.6 (0.41), (−0.2, 1.4) | 1.0 (0.24), (0.5, 1.5) | 1.0 (0.25), (0.5, 1.5) | 1.9 (0.28), (1.3, 2.5) | 2.3 (0.29), (1.7, 2.9) | 1.0 (0.36), (0.3, 1.7) | 2.1 (0.37), (1.4, 2.8) |
| Incidence of tachycardia (%)* | ||||||||||
| Tachycardia events, N (%) | 43 (3.1) | 21 (4.9) | 52 (3.8) | 43 (4.6) | 16 (3.2) | |||||
SBP, systolic blood pressure; DBP, diastolic blood pressure.
*
Based on TEAE and/or observations of pulse rate ≥ 100 bpm captured by patient diary.
†
Adjusted change from baseline is generated from the ANCOVA model with treatment group, gender and study as fixed factors, and baseline as a covariate.
‡
Differences in the adjusted means are calculated by subtracting the adjusted mean of placebo from the adjusted mean of treatment group.