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21 Nov 2009

New data on Vesicare show significant improvements in urgency for patients with overactive bladder

- 30 Nov 2006
By Edelman Public Relations   
Page 2 of 3

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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About Overactive Bladder

Overactive bladder affects an estimated 17 million men and women in the United States, yet many mistakenly believe it cannot be treated. For people with OAB, inappropriate signals are sent to the muscles in the bladder causing them to contract before the bladder is full. These bladder contractions may cause strong, sudden urges, and a frequent need to go to the bathroom, sometimes without any advance warning. Many patients cope with their symptoms by restricting fluids, carrying extra clothing, and "mapping" bathroom locations wherever they go. Some patients even curtail their social activities for fear of an embarrassing leaking accident.

The effects of OAB take not only a physical, social, and emotional toll on patients, but a financial one as well. It is estimated that costs related to OAB were nearly $14 billion in the United States in 2000, similar to that of gynecological and breast cancers, osteoporosis, or arthritis.

About VESIcare® (solifenacin succinate)

VESIcare is for urgency, frequency, and leakage (overactive bladder). VESIcare is not for everyone. Patients should not take VESIcare if they have certain types of stomach, urinary, or glaucoma problems. While taking VESIcare, if patients experience a serious allergic reaction, severe abdominal pain, or become constipated for three or more days, they should tell their doctor right away. In studies, common side effects were dry mouth, constipation, blurred vision, and indigestion.

The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once-daily.

 
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