Table 2.
Influence of up to 12 weeks of flexible-dose darifenacin treatment on PPBC and clinical symptoms
| Previous treatment |
|||
|---|---|---|---|
| Oxybutynin ER (n= 218) | Tolterodine ER (n = 279) | All patients (n= 497) | |
| PPBC | |||
| Total study population | |||
| Patients, n | 214 | 275 | 489 |
| Baseline | |||
| Mean ± SD | 4.6 ± 0.79 | 4.5 ± 0.76 | 4.5 ± 0.77 |
| Median | 5.0 | 4.0 | 4.0 |
| 12 weeks | |||
| Mean ± SD | 3.1 ± 1.24 | 3.1 ± 1.27 | 3.1 ± 1.25 |
| Median | 3.0 | 3.0 | 3.0 |
| Change | |||
| Mean ± SD | −1.4 ± 1.26 | −1.4 ± 1.33 | −1.4 ± 1.30 |
| Median | −1.0 | −1.0 | −1.0 |
| p-value* | < 0.0001 | < 0.0001 | < 0.0001 |
| Patients receiving prior ER antimuscarinic therapy at screening | |||
| Patients, n | 75 | 94 | 169 |
| Baseline | |||
| Mean ± SD | 4.6 ± 0.85 | 4.6 ± 0.82 | 4.6 ± 0.84 |
| Median | 5.0 | 5.0 | 5.0 |
| 12 weeks | |||
| Mean ± SD | 3.2 ± 1.26 | 2.9 ± 1.31 | 3.0 ± 1.29 |
| Median | 3.0 | 3.0 | 3.0 |
| Change | |||
| Mean ± SD | −1.4 ± 1.41 | −1.6 ± 1.34 | −1.5 ± 1.37 |
| Median | −1.0 | −2.0 | −1.0 |
| p-value* | < 0.0001 | < 0.0001 | < 0.0001 |
| Micturitions/day | |||
| Patients, n | 208 | 274 | 482 |
| Baseline | |||
| Mean ± SD | 10.9 ± 2.90 | 10.8 ± 2.60 | 10.8 ± 2.73 |
| Median | 10.2 | 10.4 | 10.2 |
| 12 weeks | |||
| Mean ± SD | 8.9 ± 2.60 | 8.4 ± 2.56 | 8.6 ± 2.59 |
| Median | 8.4 | 8.2 | 8.2 |
| Change | |||
| Mean ± SD (absolute) | −2.0 ± 2.23 | −2.2 ± 2.50 | −2.2 ± 2.39 |
| Median (absolute) | −1.8 | −2.0 | −2.0 |
| Median (%) | −17.4 | −21.2 | −19.5 |
| p-value* | < 0.0001 | < 0.0001 | < 0.0001 |
| Urgency episodes/day | |||
| Patients, n | 208 | 274 | 482 |
| Baseline | |||
| Mean ± SD | 6.3 ± 3.41 | 6.2 ± 3.30 | 6.2 ± 3.34 |
| Median | 5.6 | 5.6 | 5.6 |
| 12 weeks | |||
| Mean ± SD | 3.4 ± 3.45 | 3.0 ± 3.34 | 3.2 ± 3.39 |
| Median | 2.2 | 1.8 | 1.8 |
| Change | |||
| Mean ± SD (absolute) | −2.8 ± 2.97 | −3.2 ± 3.35 | −3.1 ± 3.20 |
| Median (absolute) | −2.6 | −3.0 | −2.8 |
| Median (%) | −55.5 | −64.0 | −61.6 |
| p-value* | < 0.0001 | < 0.0001 | < 0.0001 |
| UUI episodes/week | |||
| Patients, n | 175 | 227 | 402 |
| Baseline | |||
| Mean ± SD | 16.7 ± 14.81 | 16.5 ± 16.15 | 16.6 ± 15.56 |
| Median | 11.2 | 11.2 | 11.2 |
| 12 weeks | |||
| Mean ± SD | 6.8 ± 11.49 | 5.0 ± 9.73 | 5.8 ± 10.56 |
| Median | 2.8 | 1.4 | 1.4 |
| Change | |||
| Mean ± SD (absolute) | −9.9 ± 13.89 | −11.5 ± 13.25 | −10.8 ± 13.54 |
| Median (absolute) | −8.4 | −8.4 | −8.4 |
| Median (%) | −83.3 | −88.0 | −85.7 |
| p-value* | < 0.0001 | < 0.0001 | < 0.0001 |
*p-value for absolute (PPBC) or % change from baseline using the Wilcoxon signed-rank test. Data at 12 weeks were calculated using last-observation carried forward method. ER, extended-release; PPBC, Patient Perception of Bladder Condition; SD, standard deviation; UUI, urgency urinary incontinence.