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

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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.

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Acknowledgments

Funding for editorial support, drafting and revising the manuscript, and for the analysis was provided by Novartis Pharma AG. The authors would like to thank Andrea Larson-Peters (Section Head at Procter & Gamble and previous employee of Warner Chilcott Pharmaceuticals Inc.) for her input into project development, data analysis, and manuscript writing/editing; Karen Boyle (Senior Biostatistician with Rho) for her input into data analysis; and Claire Chinn (professional medical writer with ACUMED®) for her assistance in drafting and revising this manuscript.

Conflicts of interest

V. Khullar is a Consultant to Novartis and a past study investigator, J. Foote has received honoraria from Novartis, Y. Seifu is an employee of Novartis, and M. Egermark is a stockholder and previous employee of Novartis.

Author information

Authors and Affiliations

  1. Urogynaecology Department, St Mary’s Hospital, Imperial College, London, UK

    Vik Khullar

  2. Midtown Urology & Midtown Urology Surgical Center, Atlanta, GA, USA

    Jenelle Foote

  3. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    Yodit Seifu

  4. Roche Diagnostics Scandinavia AB, Stockholm, Sweden

    Mathias Egermark

Authors
  1. Vik Khullar
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  2. Jenelle Foote
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  3. Yodit Seifu
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  4. Mathias Egermark
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Corresponding author

Correspondence to Vik Khullar.

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Khullar, V., Foote, J., Seifu, Y. et al. Time-to-effect with darifenacin in overactive bladder: a pooled analysis. Int Urogynecol J 22, 1573–1580 (2011). https://doi.org/10.1007/s00192-011-1522-0

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  • DOI: https://doi.org/10.1007/s00192-011-1522-0

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