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

Abstract

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.

• Authors: Vik Khullar, Jenelle Foote, Yodit Seifu, Mathias Egermark
• Journal: International urogynecology journal (Int Urogynecol J) Vol. 22 Issue 12 Pg. 1573-80 (Dec 2011) ISSN: 1433-3023 [Electronic] England
• PMID: 22006023 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Benzofurans
• Muscarinic Antagonists
• Pyrrolidines
• darifenacin

Topics

• Adult
• Aged
• Aged, 80 and over
• Benzofurans (adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Incidence
• Male
• Medical Records
• Middle Aged
• Muscarinic Antagonists (adverse effects, therapeutic use)
• Pyrrolidines (adverse effects, therapeutic use)
• Retrospective Studies
• Time Factors
• Treatment Outcome
• Urinary Bladder, Overactive (drug therapy, epidemiology)