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Efficacy and tolerability of fesoterodine in women with overactive bladder

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Abstract

Introduction and hypothesis

We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB).

Methods

This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12.

Results

By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate.

Conclusions

Fesoterodine is efficacious and well tolerated in women with OAB.

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Abbreviations

5-HMT:

5-Hydroxymethyl tolterodine

AE:

Adverse event

ANCOVA:

Analysis of covariance

CYP:

Cytochrome P450

EOT:

End of treatment

ER:

Extended release

FESO:

Fesoterodine

HRQL:

Health-related quality of life

LOCF:

Last observation carried forward

LSM:

Least squares mean

OAB:

Overactive bladder

MVV:

Mean voided volume

PBO:

Placebo

SD:

Standard deviation

SEM:

Standard error of the mean

TOL ER:

Tolterodine ER

UUI:

Urgency urinary incontinence

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Acknowledgments

Editorial assistance was provided by Nancy Sheridan from Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Funding

Funding for this study was provided by Schwarz BioSciences GmbH and Pfizer Inc.

Conflicts of interest

Peter Sand is an advisor for Astellas, Allergan, American Medical Systems, Boston Scientific, Coloplast, GlaxoSmithKline, Ortho McNeil, Pfizer Inc, and Watson Pharma; an investigator for Allergan, Boston Scientific, Ortho McNeil, Pfizer Inc, and Watson Pharma and a speaker for Allergan, Astellas, GlaxoSmithKline, Ortho McNeil, and Watson Pharma. Jon Morrow and Tamara Bavendam are employees of Pfizer Inc. Dana Creanga is a consultant for Pfizer Inc. Victor Nitti is an investigator for Schwarz Pharma, a consultant and lecturer for Pfizer Inc and Novartis, a consultant and investigator for Allergan, a consultant for Astellas, an advisor for Watson Pharma, Serenity Pharmaceuticals, and Coloplast Corp, and a lecturer for American Medical Systems.

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Authors and Affiliations

  1. Evanston Continence Center, Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, 1000 Central Street, Suite 730, Evanston, IL, 60201, USA

    Peter K. Sand

  2. Pfizer Inc, New York, NY, USA

    Jon D. Morrow, Tamara Bavendam & Dana L. Creanga

  3. New York University Medical Center, New York, NY, USA

    Victor W. Nitti

Authors
  1. Peter K. Sand
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  2. Jon D. Morrow
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  3. Tamara Bavendam
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  4. Dana L. Creanga
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  5. Victor W. Nitti
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Corresponding author

Correspondence to Peter K. Sand.

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Sand, P.K., Morrow, J.D., Bavendam, T. et al. Efficacy and tolerability of fesoterodine in women with overactive bladder. Int Urogynecol J 20, 827–835 (2009). https://doi.org/10.1007/s00192-009-0857-2

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  • DOI: https://doi.org/10.1007/s00192-009-0857-2

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