OAB drug reduces urgency episodes, increases warning time

December 21, 2006

Patients with overactive bladder who are treated with solifenacin succinate (Vesicare) experience statistically significant reductions in episodes of urgency, suggests a study presented at the International Continence Society annual meeting in Christchurch, New Zealand.

Patients with overactive bladder who are treated with solifenacin succinate (Vesicare) experience statistically significant reductions in episodes of urgency, suggests a study presented at the International Continence Society annual meeting in Christchurch, New Zealand. The study also demonstrated that patients taking the drug show a statistically significant increase in warning time compared with patients taking placebo (31.5 seconds vs. 12 seconds median increase, respectively; p<.03).

“Urgency is generally considered to be the most important symptom for patients suffering from OAB,” said lead author Marc Toglia, MD, of 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.”

The Vesicare Efficacy and Safety in Patients with Urgency Study (VENUS) was a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy of solifenacin on urgency symptoms in 739 patients with overactive bladder. Patients received either solifenacin, 5 mg, or placebo daily for the first 4 weeks of the study. At weeks 4 and 8, the dose of solifenacin (or matching placebo) could be maintained, increased to 10 mg/day, or decreased to 5 mg/day. Changes in symptoms including urgency, frequency, and incontinence were measured via 3-day micturition diaries. Patients’ perceptions of urgency were assessed using two scales.

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 solifenacin compared with 2.73 (p<.0001) for patients receiving placebo. In a secondary endpoint, more patients taking solifenacin 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 solifenacin succinate reported improvements in their degree of urgency as well compared with placebo (42.1% vs. 33.1%).

The most common adverse events were dry mouth, constipation, blurred vision, dizziness, and fatigue.