Time-to-effect with darifenacin in overactive bladder: a pooled analysis.

INTRODUCTION AND HYPOTHESIS

This study was conducted to assess time-to-effect with darifenacin in patients with overactive bladder (OAB).

METHODS

Efficacy and safety data were pooled from 1,059 patients (19-88 years, 85% women) randomized to darifenacin 7.5 or 15 mg once daily or matched placebo in three double-blind 12-week studies. Patients completed electronic bladder symptom diaries (number of micturitions/day; incontinence episodes/day; urgency episodes/day). A post hoc efficacy analysis was performed on the earliest recorded timepoints.

RESULTS

The full analysis population comprised 1,053 patients. Statistically significant improvements were observed in all OAB symptoms (except nocturnal awakenings) for both darifenacin doses versus placebo at week 2, with further improvements over 6 and 12 weeks. Both darifenacin doses significantly improved all OAB symptoms from as early as days 6-8 versus placebo.

CONCLUSIONS

Darifenacin 7.5 and 15 mg significantly reduced OAB symptoms throughout the study. The rapid onset-of-effect is desirable to patients with OAB and useful for their clinical management.