For Immediate Release
NEWLY PRESENTED DATA ON VESICARE® (solifenacin succinate)
SHOW SIGNIFICANT IMPROVEMENTS IN URGENCY FOR PATIENTS
WITH OVERACTIVE BLADDER
- VESIcare is the First Overactive Bladder Treatment At An Approved Dose to Show a
Statistically Significant Increase In Warning Time Before Urination-
Christchurch, New Zealand – December 1, 2006 – 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 often is cited as one of the most bothersome symptom for patients with
OAB,” said Marc Toglia, MD, Urogynecology Associates of Pennsylvania.
“Increasing the length of time between the first feeling of urgency and urination is
an important goal of OAB therapy because often patients miss making it to the
bathroom.”
1
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.
2
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.
As with other anticholinergic agents, VESIcare is contraindicated in patients with
urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in
patients with hypersensitivity to the product.
3
As with other anticholinergic agents, VESIcare should be administered with
caution to patients with bladder outflow obstruction, decreased gastrointestinal
motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function.
Doses of VESIcare higher than 5 mg are not recommended in patients with
severe renal impairment, moderate hepatic impairment, or when administered
with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients
with severe hepatic impairment is not recommended.
The most common adverse events reported by patients were dry mouth (10.9%,
27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%,
1.8%) and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5mg, 10mg, and
placebo, respectively.
The overall rate of serious adverse events was 2%. For the 10 mg dose, three
intestinal serious adverse events were reported (one fecal impaction, one colonic
obstruction and one intestinal obstruction). For the 5 mg dose, one case of
angioneurotic edema was reported.
For complete prescribing information for VESIcare, go to www.vesicare.com.
4
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyobased Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to
improving the health of people around the world through the provision of
innovative and reliable pharmaceutical products. The organization is committed
to becoming a global pharmaceutical company by combining outstanding R&D
and marketing capabilities and continuing to grow in the world pharmaceutical
market. For more information about Astellas Pharma US, Inc., please visit our
website at www.astellas.com/us.
About GlaxoSmithKline
GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and
healthcare companies, is committed to improving the quality of human life by
enabling people to do more, feel better, and live longer. For more information,
please visit the company’s Web site at www.gsk.com.
For more information or full prescribing information, contact:
GlaxoSmithKline:
Marc Meachem, Product Communications: 919-483-8756
Astellas:
Maribeth Landwehr, Corporate Communications: 847-317-8988
###
5