Table 4.
Change from baseline to EoT in vital signs as measured by patient diary in the morning and afternoon (SAF).
| Vital signs | Pooled studies (SCORPIO/ARIES/CAPRICORN) |
TAURUS |
||
|---|---|---|---|---|
| Placebo | Mirabegron 50 mg | Mirabegron 50 mg | Tolterodine ER 4 mg | |
| SBP (a.m.), mmHg | n = 363 | n = 383 | n = 205 | n = 206 |
| Baseline mean (SE) | 132.2 (0.87) | 132.6 (0.81) | 133.3 (1.03) | 132.2 (1.02) |
| Adjusted change from baseline (SE) [95% CI] | 0.2 (0.47) | 1.7 (0.46) | 1.7 (0.66) [0.4, 3.0] | 0.9 (0.66) [−0.4, 2.2] |
| Mean difference versus placebo (SE) [95% CI] | – | 1.5 (0.65) [0.2, 2.8] | N/A | N/A |
| SBP (p.m.), mmHg | n = 361 | n = 383 | n = 204 | n = 206 |
| Baseline mean (SE) | 130.9 (0.79) | 131.5 (0.73) | 132.2 (0.90) | 131.3 (0.93) |
| Adjusted change from baseline (SE) [95% CI] | 1.4 (0.49) | 1.9 (0.48) | 1.9 (0.65) [0.6, 3.2] | 1.2 (0.65) [−0.1, 2.4] |
| Mean difference versus placebo (SE) [95% CI] | – | 0.5 (0.68) [−0.8, 1.9] | N/A | N/A |
| DBP (a.m.), mmHg | n = 363 | n = 383 | n = 205 | n = 206 |
| Baseline mean (SE) | 78.6 (0.50) | 79.3 (0.44) | 79.5 (0.61) | 79.0 (0.61) |
| Adjusted change from baseline (SE) [95% CI] | 0.0 (0.29) | 0.6 (0.29) | −0.2 (0.41) [−1.0, 0.6] | 0.3 (0.41) [−0.5, 1.1] |
| Mean difference versus placebo (SE) [95% CI] | – | 0.5 (0.41) [−0.3, 1.3] | N/A | N/A |
| DBP (p.m.), mmHg | n = 361 | n = 383 | n = 204 | n = 206 |
| Baseline mean (SE) | 76.5 (0.47) | 76.9 (0.46) | 77.4 (0.63) | 77.0 (0.60) |
| Adjusted change from baseline (SE) [95% CI] | 0.8 (0.32) | 1.0 (0.31) | 0.6 (0.42) [−0.2, 1.4] | 0.6 (0.42) [−0.2, 1.5] |
| Mean difference versus placebo (SE) [95% CI] | – | 0.2 (0.44) [−0.6, 1.1) | N/A | N/A |
| Pulse rate (a.m.), bpm | n = 363 | n = 383 | n = 205 | n = 206 |
| Baseline mean (SE) | 67.5 (0.56) | 67.3 (0.55) | 69.3 (0.79) | 66.5 (0.73) |
| Adjusted change from baseline (SE) [95% CI] | 0.3 (0.34) | 1.3 (0.33) | −0.6 (0.44) [−1.4, 0.3] | 0.4 (0.45) [−0.5, 1.3] |
| Mean difference versus placebo (SE) [95% CI] | – | 1.0 (0.47) [0.1, 1.9] | N/A | N/A |
| Pulse rate (p.m.), bpm | n = 361 | n = 383 | n = 204 | n = 206 |
| Baseline mean (SE) | 73.2 (0.60) | 72.9 (0.55) | 73.2 (0.73) | 71.4 (0.76) |
| Adjusted change from baseline (SE) [95% CI] | 0.2 (0.35) | 0.8 (0.34) | −1.1 (0.47) [−2.1, −0.2] | 0.8 (0.47) [−0.2, 1.7] |
| Mean difference versus placebo (SE) [95% CI] | – | 0.6 (0.49) [−0.3, 1.6] | N/A | N/A |
Adjusted change from baseline was generated from the ANCOVA model with treatment, sex, study, and treatment-by-sex as fixed factors, and baseline as a covariate. Difference of the adjusted means versus placebo was calculated by subtracting the adjusted mean of placebo from the adjusted mean of the treatment group.
ANCOVA, analysis of covariance; bpm, beats per minute; CI, confidence interval; DBP, diastolic blood pressure; ER, extended release; EoT, end of treatment; N/A, not applicable; SBP, systolic blood pressure; SAF, safety analysis set; SE, standard error.