New Data On Vesicare Show Significant Improvements In Urgency For Patients With Overactive Bladder

December 5, 2006 – 1:24 pm | posted in Clinical Trials / Drug Trials, Urology / Nephrology

Patients with overactive bladder (OAB) treated with VESIcare (solifenacin succinate) experienced statistically significant reductions in episodes of urgency (the sudden, compelling need to urinate), according to a new study presented today at the 36th Annual Meeting of the International Continence Society.

A secondary endpoint from this study also presented today demonstrated that patients taking VESIcare experienced a statistically significant increase in warning time - compared with patients taking placebo (31.5 seconds vs. 12.0 seconds median increase, respectively; p<0.03). In this study warning time was defined as the time from the first sensation of urgency to voiding (going to the bathroom). VESIcare is the first OAB treatment at an approved dose to show a statistically significant increase in warning time.

“Urgency is generally considered to be the most important symptom for patients suffering from OAB,” said Marc Toglia, MD, Urogynecology Associates of Philadelphia. “Increasing the time interval between the first sensation to void and the act of voiding may be an important goal as it could reduce the likelihood of a patient experiencing an incontinent episode.”

VENUS Study Findings

VENUS (VESIcare Efficacy and Safety in PatieNts with Urgency Study) was a randomized, double-blind, placebo-controlled, parallel-group, flexible-dosing, multicenter study designed to assess the efficacy of VESIcare on urgency symptoms in patients (n=739) with OAB. Patients received either 5 mg VESIcare or placebo daily for the first four weeks of the study. At weeks four and eight, the dose of VESIcare (or matching placebo) could be maintained, increased to 10 mg/day, or decreased to 5 mg/day. Changes in OAB symptoms including urgency, frequency, and incontinence were measured via 3-day micturition (acts of urination) diaries. Patients’ perceptions of urgency were assessed using the Indevus Urgency Severity Scale (IUSS) and the Urgency Perception Scale (UPS). Warning time was measured using a stopwatch.

At the end of the 12-week study the primary endpoint of mean change in urgency episodes per 24 hours had decreased by 3.91 for patients treated with VESIcare (n=348) compared with 2.73 (p<.0001) for patients receiving placebo (n=336). In a secondary endpoint, using the IUSS, more patients taking VESIcare who had described their urgency as “moderate” or “severe” at baseline assessed it as “mild” or “moderate” at the end, compared with placebo (58.1% vs. 41.7%). More patients taking VESIcare reported improvements in their degree of urgency on the UPS as well compared to placebo (42.1% vs. 33.1%).

For this study the most common drug-related, treatment-emergent adverse events reported were dry mouth (25.3%, 9.0%), constipation (14.8%, 9.3%), blurred vision (3.8%, 1.1%), dizziness (3.2%, 1.9%), and fatigue (2.7%, 1.1%) with VESIcare 5 mg or 10 mg and placebo, respectively.

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