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Efficacy of darifenacin in patients with varying baseline symptom severity - Abstract Show Comments PDF Print E-mail
  
Thursday, 05 November 2009

Vanderbilt University School of Medicine, Department of Urology, A1302, Medical Center North, Nashville, TN 37232, USA.

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The severity of overactive bladder (OAB) symptoms such as incontinence episodes (IEs), urgency episodes, and micturition frequency varies between patients. It is therefore of interest to determine if patients respond differently to OAB antimuscarinic therapy according to symptom severity.

The objective of the present study was to evaluate data on symptom reduction and time of onset of action for patients in a pooled analysis of three phase III darifenacin studies. These data were analyzed in relation to darifenacin dose received and OAB symptom severity at baseline, as defined by IE frequency at randomization.

The investigation was a retrospective analysis of pooled data from three 12-week, fixed-dose, double-blind studies involving 1053 adults (19-88 years old) who received darifenacin 7.5 mg or 15 mg once daily and matched patients who received placebos. Patients with mild/moderate OAB (defined as < 21 IEs/week at baseline) or severe OAB (? 21 IEs/week) were analyzed at 2, 6, and 12 weeks or the end of the study. Measurements included the absolute and percentage change from baseline in IEs/week, urgency episodes/day, micturitions/day, and mean volume/void.

There was a statistically significant improvement in OAB symptoms at week 12 or the last visit for patients with mild/moderate OAB taking darifenacin 7.5 mg and 15 mg, when compared with patients taking the placebo. There was also a statistically significant improvement in OAB symptoms at week 12 for patients with severe OAB taking darifenacin 15 mg, when compared with patients taking the placebo. Patients taking darifenacin 15 mg had statistically significant improvements in as few as 2 weeks for all OAB symptoms measured when compared with patients taking the placebo, regardless of baseline severity.

Both darifenacin 7.5 mg and 15 mg effectively relieved OAB symptoms, with statistically significant reductions in symptoms seen in as few as 2 weeks. For patients with mild/moderate OAB, 7.5 mg was sufficient to achieve a statistically significant effect; for patients with severe OAB, 15 mg was the most effective dose. These findings highlight the importance of dose titration according to individual patient needs.

Written by:
Dmochowski RR, Larson-Peters A, Aronstein WS, Seifu Y.   Are you the author?

Reference:
UroToday Int J. 2009 Jun;2(3).
doi:10.3834/uij.1944-5784.2009.06.16

UroToday.com Overactive Bladder (OAB) Section

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