Solifenacin at 3 years: a review of efficacy and safety.

Now on the market in the United States for almost 3 years and available in 48 countries worldwide, solifenacin 5 mg or 10 mg once daily continues to demonstrate a profile of safety and efficacy as a treatment for incontinence, urgency, and other symptoms of OAB. More than 2.2 million patients have been treated worldwide with solifenacin. Safety and efficacy data across numerous studies in several thousand patients, along with flexible dosing, support the use of this agent as a first-line antimuscarinic treatment for OAB. Data from large randomized controlled trials such as VENUS and STAR show statistically significant superiority compared with placebo and improved outcomes over those achieved with tolterodine ER 4 mg. Solifenacin is an agent of choice for OAB-related incontinence, with more than 50% of incontinent patients reporting no incontinence episodes after 12 weeks of solifenacin therapy. In addition to improved efficacy, solifenacin offers good tolerability with a low incidence of side effects. Once-daily, flexible dosing with this agent provides 24-hour control of OAB symptoms and significantly increases warning time (the period from onset of urgency to voiding), which may also increase a patient's chance of avoiding episodes of incontinence.