Darifenacin's Effectiveness In OAB Wet Patients As Measured By Dry Days

Main Category: Urology / Nephrology
Article Date: 27 Oct 2008 - 2:00 PDT

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PHILADELPHIA, PA, USA (UroToday.com) - This analysis set forth to determine the onset and number of consecutive dry days and reductions of UI episodes (IEs) provided by darifenacin, using pooled data from 3 phase III studies (multicenter, randomized, double-blind, placebo-controlled 12-week studies with darifenacin of fixed-doses of 7.5 and 15 mg once daily).

Each study was preceded by a screening visit, 2-week washout (if required) and a 2 week treatment-free or placebo run-in period. Patients were then randomized to 12 weeks' double-blind treatment with study medication. Subjects included men and women ≥18 years of age with symptoms of OAB for ≥6 months; 5-50 IEs per week (incontinence) during the run-in period; an average of ≥8 micturitions per 24 hours; and ≥1 urgency episode per 24 hours. Efficacy was determined from electronic daily diaries used to record OAB symptoms, including IEs. Incontinence data were used to determine the proportion of patients achieving ≥3 consecutive dry days and reductions in IEs. A dry day was defined as not having an IE recorded during a 24-hour period. IE responses were grouped into three categories: reductions of >3, >5 and >10 IEs/week from baseline. Darifenacin 7.5 and 15 mg treatment was well tolerated and effective. In both darifenacin dose groups, more patients achieved ≥3 consecutive dry days compared with placebo. Onset of improvement, as indicated by significant changes from placebo, was seen within 2 weeks of darifenacin treatment and sustained over time (12-week observation period).

As symptom bother has been related to UI, increases in the number of dry days may be more clinically relevant for OAB patients with UI than other study endpoints, such as reductions in urgency or micturitions.

Presented by D. Newman, W. S. Aronstein, Y. Seifu, A. Peters-Larson, and L. Mongay at the 39th Annual Conference of the Society of Urologic Nurses and Associates - October 3 - 6, 2008 - Philadelphia, PA, USA

Reported by UroToday.com Contributing Editor Diane K. Newman, MSN, CRNP, FAAN, BCIA-PMDB

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