Table 2.
Summary of primary and secondary efficacy end-points (FAS and FAS-I)
| Placebo | Mirabegron 50 mg | Mirabegron 100 mg | |
|---|---|---|---|
| Co-primary end-points | |||
| Change from baseline to Final Visit in the mean number of incontinence episodes/24 h (FAS-I) | |||
| Baseline | 2.73 (0.09) | 2.71 (0.09) | 2.79 (0.10) |
| Final Visit | 1.64 (0.09) | 1.23 (0.08) | 1.25 (0.09) |
| Change from baseline | −1.09 (0.09) | −1.48 (0.08) | −1.54 (0.09) |
| Adjusted change from baseline* (95% CI) | −1.10 (−1.23, −0.97) | −1.49 (−1.63, −1.36) | −1.50 (−1.67, −1.34) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.40 (−0.58, −0.21)3 | −0.41 (−0.62, −0.19)3 |
| Change from baseline to Final Visit in the mean number of micturitions/24 h (FAS) | |||
| Baseline | 11.58 (0.09) | 11.70 (0.09) | 11.58 (0.10) |
| Final Visit | 10.39 (0.09) | 9.93 (0.09) | 9.83 (0.11) |
| Change from baseline | −1.18 (0.08) | −1.77 (0.08) | −1.75 (0.09) |
| Adjusted change from baseline* (95% CI) | −1.20 (−1.34, −1.06) | −1.75 (−1.89, −1.61) | −1.74 (−1.91, −1.56) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.55 (−0.75, −0.36)† | −0.54 (−0.77, −0.31)† |
| Key secondary end-points | |||
| Change from baseline to Final Visit in the mean volume voided/micturition (FAS) | |||
| Baseline | 159.2 (1.54) | 159.0 (1.55) | 157.9 (1.89) |
| Final Visit | 168.6 (1.90) | 180.2 (2.01) | 179.9 (2.39) |
| Change from baseline | 9.4 (1.31) | 21.2 (1.31) | 22.0 (1.52) |
| Adjusted change from baseline* (95% CI) | 9.4 (6.9, 12.0) | 21.4 (18.8, 23.9) | 21.7 (18.5, 24.9) |
| Adjusted difference vs. placebo* (95% CI) | – | 11.9 (8.3, 15.5)† | 12.3 (8.1, 16.5)† |
| Change from baseline to week 4 in the mean number of incontinence episodes/24 h (FAS-I) | |||
| Baseline | 2.73 (0.09) | 2.71 (0.09) | 2.79 (0.10) |
| Week 4 | 2.06 (0.10) | 1.59 (0.08) | 1.69 (0.10) |
| Change from baseline | −0.67 (0.08) | −1.12 (0.08) | −1.10 (0.09) |
| Adjusted change from baseline* (95% CI) | −0.67 (−0.81, −0.54) | −1.12 (−1.26, −0.98) | −1.09 (−1.27, −0.92) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.45 (−0.64, −0.26)† | −0.42 (−0.65, −0.20)† |
| Change from baseline to week 4 in the mean number of micturitions/24 h (FAS) | |||
| Baseline | 11.58 (0.09) | 11.71 (0.09) | 11.58 (0.10) |
| Week 4 | 10.82 (0.09) | 10.52 (0.10) | 10.26 (0.11) |
| Change from baseline | −0.76 (0.07) | −1.19 (0.07) | −1.32 (0.09) |
| Adjusted change from baseline* (95% CI) | −0.77 (−0.90, −0.64) | −1.17 (−1.30, −1.04) | −1.33 (−1.50, −1.16) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.40 (−0.59, −0.22)† | −0.56 (−0.78, −0.35)† |
| Mean level of urgency (FAS) | |||
| Baseline | 2.39 (0.02) | 2.42 (0.02) | 2.46 (0.02) |
| Final Visit | 2.25 (0.02) | 2.15 (0.02) | 2.19 (0.02) |
| Change from baseline | −0.14 (0.02) | −0.27 (0.02) | −0.27 (0.02) |
| Adjusted change from baseline* (95% CI) | −0.15 (−0.18, −0.12) | −0.26 (−0.30, −0.23) | −0.26 (−0.30, −0.22) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.11 (−0.16, −0.07)† | −0.11 (−0.16, −0.06)† |
| Mean number of urgency incontinence episodes/24 h (FAS−I) | |||
| Baseline | 2.42 (0.08) | 2.42 (0.08) | 2.53 (0.10) |
| Final Visit | 1.46 (0.08) | 1.05 (0.07) | 1.11 (0.09) |
| Change from baseline | −0.96 (0.08) | −1.37 (0.07) | −1.42 (0.09) |
| Adjusted change from baseline* (95% CI) | −0.98 (−1.10, −0.86) | −1.38 (−1.50, −1.26) | −1.38 (−1.53, −1.23) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.40 (−0.57, −0.23)† | −0.40 (−0.60, −0.20)† |
| Mean number of urgency episodes (PPIUS grade 3 or 4)/24 h (FAS) | |||
| Baseline | 5.61 (0.10) | 5.80 (0.10) | 5.96 (0.12) |
| Final Visit | 4.38 (0.11) | 3.85 (0.11) | 4.02 (0.13) |
| Change from baseline | −1.23 (0.10) | −1.95 (0.10) | −1.94 (0.12) |
| Adjusted change from baseline* (95% CI) | −1.29 (−1.47, −1.11) | −1.93 (−2.11, −1.75) | −1.89 (−2.11, −1.66) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.64 (−0.89, −0.39)† | −0.60 (−0.89, −0.31)† |
| Additional secondary end-points | |||
| Change from baseline to Final Visit in mean number of nocturia episodes/24 h (FAS) | |||
| Baseline | 2.18 (0.04) | 2.22 (0.04) | 2.25 (0.05) |
| Final Visit | 1.78 (0.04) | 1.66 (0.04) | 1.71 (0.05) |
| Change from baseline | −0.41 (0.04) | −0.56 (0.04) | −0.54 (0.04) |
| Adjusted change from baseline* (95% CI) | −0.42 (−0.48, −0.35) | −0.55 (−0.62, −0.49) | −0.54 (−0.62, −0.46) |
| Adjusted difference vs. placebo* (95% CI) | – | −0.14 (−0.23, −0.05)‡ | −0.12 (−0.23, −0.02)‡ |
| Change from baseline to Final Visit in TS-VAS (FAS) | |||
| Baseline | 4.87 (0.11) | 4.82 (0.11) | 4.43 (0.13) |
| Final Visit | 6.05 (0.10) | 6.79 (0.09) | 6.94 (0.11) |
| Change from baseline | 1.18 (0.11) | 1.96 (0.12) | 2.51 (0.14) |
| Adjusted change from baseline* (95% CI) | 1.25 (1.08, 1.42) | 2.01 (1.84, 2.19) | 2.33 (2.11, 2.55) |
| Adjusted difference vs. placebo* (95% CI) | – | 0.76 (0.52, 1.01)‡ | 1.08 (0.80, 1.37)‡ |
All values mean (SE) unless otherwise stated.
*
Estimates are based on an analysis of covariance model, which included treatment group, gender and study as fixed factors, and baseline as a covariate.
†
p < 0.05 vs. placebo with multiplicity adjustment.
‡
p < 0.05 vs. placebo without multiplicity adjustment.