Large-Scale Study in the British Journal of Urology Shows More Than One Out of Three Women With Urinary Incontinence Suffer From
February 09 2004 - 8:00AM
PR Newswire (US)
Large-Scale Study in the British Journal of Urology Shows More Than
One Out of Three Women With Urinary Incontinence Suffer From Stress
Urinary Incontinence Journal Also Reports Duloxetine Significantly
Reduces the Frequency of SUI Episodes and ImprovesQuality of Life
for Women Globally INDIANAPOLIS and INGELHEIM, Germany, Feb. 9
/PRNewswire/ -- Two separate studies appear now on the British
Journal of Urology International Web site: one addressing the
prevalence of stress urinary incontinence (SUI) and the other
highlighting data on duloxetine, an investigational agent for this
medical disorder currently under regulatory review. The first is a
large cross-country prevalence survey showing that 35 percent of
the 17,080 women analyzed reported having urinary incontinence
(UI). Thirty-seven percent of these incontinent women reported
having SUI, the most prevalent form of UI(1). The second study, a
global Phase III clinical trial comparing duloxetine versus placebo
in the treatment of SUI, shows that duloxetine significantly
decreased incontinence episodes frequency (IEF) with comparable
significant Incontinence Quality of Life (I-QOL) in those women
studied who suffer from SUI(2). Both studies will be published in
the February print edition of the British Journal of Urology
International. Prevalence Survey: SUI Most Common Form of Urinary
Incontinence Among Women The study gathered data using a postal
survey to randomly selected women ages 18 years and older in
France, Germany, Spain and the United Kingdom. The prevalence of UI
by type found in this study shows that SUI was the most common type
of UI overall. The findings also revealed that over one-third of
all women surveyed reported having experienced UI. However,
two-thirds of those affected had never consulted a health care
professional for treatment. "Many misperceptions and social
embarrassment surround SUI, making this common disorder one which
unfortunately is coped with in silence. Low consultation rates
signal there is a great need to raise awareness of this bothersome
condition affecting millions of women worldwide," said Professor
Steinar Hunskaar, Section for General Practice, Department of
Public Health and Primary Health Care, University of Bergen,
Norway. Global Duloxetine Phase III Study: Reduced Frequency of
Episodes of SUI The global Phase III clinical trial results of
duloxetine, conducted in 38 study centers, randomized 458 women
ages 27 to 79 from seven countries: Argentina, Australia, Brazil,
Finland, Poland, South Africa and Spain. The results showed that
patients treated with 80 mg of duloxetine experienced a median
reduction of 54 percent in the frequency of incontinence episodes
(IEF), a primary measure of efficacy, compared to a median
reduction of 40 percent in the placebo group. This difference
accounted to be both statistically and clinically significant with
59.5 percent of duloxetine- treated women experiencing a 50 to 100
percent decrease in their IEF(2). Only 43.2 percent of subjects in
the placebo group experienced a decrease in their IEF(2). "The
safety and efficacy data from this late-stage study provide
evidence for the value of duloxetine as potentially the first drug
that will be widely available to women suffering from stress
urinary incontinence," said Dr. Richard J. Millard, Associate
Professor of Urology, The Prince of Wales Hospital, Sydney,
Australia, and lead investigator in the study. Duloxetine Treated
Patients Showed Significant Improvements in Quality of Life
Measurements in Clinical Trial Subjects in the duloxetine group
also showed significant improvements in their I-QOL scores compared
to those in the placebo group. The I-QOL is a targeted
condition-specific questionnaire that assesses the impact and
distress of symptoms of incontinence in women who suffer from this
medical disorder. I-QOL evaluates the disorder in three relevant
domains: avoidance and limiting behavior, social embarrassment, and
psychosocial impact. Duloxetine's improvements in incontinence
frequency episodes and quality of life in this study confirm those
observed in two other recently completed phase III trials in Europe
and North America(2). Safety and Efficacy Profile In the study, the
side effect profile of duloxetine was consistent with that seen
with other drugs that have an impact on serotonin and
norepinephrine. The most commonly reported adverse event (incidence
of greater than or equal to 10.0 percent and at least twice
placebo) was nausea, although it was usually mild to moderate and
resolved within one week to one month in most patients
participating in the trial. Other common adverse events included
headache, insomnia, constipation, dry mouth, dizziness and
fatigue(2), which tended to be non-progressive and mild to moderate
in almost all subjects. About duloxetine Duloxetine is a balanced
potent dual reuptake inhibitor of the neurotransmitters serotonin
and norepinephrine based on pre-clinical studies. Duloxetine is
believed to affect SUI by blocking the reuptake of serotonin and
norepinephrine in the spinal cord, and the increase in the
neurotransmitters in turn stimulates increased activity of the
nerve that stimulates the urethral sphincter. This stimulation is
believed to increasecontraction of the urethral sphincter at the
opening of the bladder, thereby helping prevent accidental urine
leakage with physical activity. The U.S. Food and Drug
Administration recently issued an approvable letter for duloxetine
for SUI. About Stress Urinary Incontinence SUI, with nearly twice
the prevalence as urge incontinence, is the most common form of
urinary incontinence among women. In the United States alone it
affects approximately 30 million women over the age of 18(i).
Although common, SUI is a medical condition that is not normal at
any age, but unfortunately many women do not seek treatment because
they are embarrassed, fear surgery, or believe it is a normal part
of aging and that nothing can be done about it. Primary causes of
SUI are nerve damage, muscle damage or weakness, and damage to the
support of the bladder and urethra. Risk factors include
childbirth, obesity, chronic coughing and constipation. About Eli
Lilly and Boehringer Ingelheim In November 2002, Eli Lillyand
Company and Boehringer Ingelheim signed a long-term agreement to
jointly develop and commercialize duloxetine hydrochloride.
Duloxetine is currently being developed for the treatment of stress
urinary incontinence (SUI) and depression. This partnership covers
most countries worldwide with few exceptions. In the USA, the
collaboration focuses on SUI. Eli Lilly and Company Lilly, a
leading innovation-driven corporation is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about
Lilly is available on http://www.lilly.com/ . Boehringer Ingelheim
Pharmaceuticals, Inc. Boehringer Ingelheim Pharmaceuticals, Inc.,
based in Ridgefield, CT, is the largestU.S. subsidiary of
Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of
the Boehringer Ingelheim group of companies. The Boehringer
Ingelheim group of companies ranks among the 20 leading
pharmaceutical corporations in the world. Headquartered in
Ingelheim, Germany, it operates globally with 156 affiliates in 44
countries and a total of about 32,000 employees. Since it was
founded in 1885, the family-owned company has been committed to
researching, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine. In 2002,
Boehringer Ingelheim posted net sales of $7.2 billion (7.6 billion
euro) while spending about one fifth of net sales in its largest
business segment Prescription Medicines on research and
development. For more information on Boehringer Ingelheim, please
see the international Internet website
http://www.boehringer-ingelheim.com/ . (1) Hunskaar S, Lose G,
Sykes D, Voss S. The prevalence of urinary incontinence in women in
four European countries. British Journal of Urology International.
2004 Feb: 324-330: http://www.blackwell-/
synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b
ju&volume=93&issue=2&year=2004&part=null (2)
Millard M J, Moore K, Rencken R, Yalcin I, Bump R C. Duloxetine vs.
placebo in the treatment of stress urinary incontinence: A four
continent randomized clinical trial. British Journal of Urology
International, 2004 Feb: 311-318 http://www.blackwell-/
synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b
ju&volume=93&issue=2&year=2004&part=null (3) Abrams
P, Cardozo L, Fall M, Griffiths, D, Rosier P, Ulmsten U, et al. The
standardization of terminology of lower urinary tract function:
report from the standardization sub-committee of the International
Continence Society. Neurourol Urodyn, 2002;21(2):167-178 (4)
Viktrup L, Female stress and urge incontinence in family practice:
insight into the lower urinary tract, International Journal of
Clinical Practice, 2002 Nov;56 (9)694-700 (5) Bymaster F.P,
Dreshfield-Ahmad L.J, Threlkeld P.G, et al. Comparative Affinity of
Duloxetine and Venlafaxine for Serotonin and Norepinephrine
Transporters in vitro and in vivo, Human Serotonin Receptor
Subtypes, and Other Neuronal Receptors. Neuropsychopharmacology,
2001: 25(6):871-880 (i) Estimated that 29.5 million women have SUI
in pure or mixed forms, based on 2000 US census bureau figures and
incontinence prevalence rate of 35% as cited in Hampel C, Wienhold
D, Benken N, Eggersmann C, Thuroff. Definition of overactive
bladder and epidemiology of urinary incontinence. Urol
1997:50(S6A):4-14 This press release contains forward-looking
statements about the potential of duloxetine for the treatmentof
stress urinary incontinence and reflects Lilly's current beliefs.
However, as with any pharmaceutical product under development,
there are substantial risks and uncertainties in the process of
development and/regulatory review. There is no guarantee that the
product will receive regulatory approvals and any indication for
which it is approved will be determined at the discretion of the
Food and Drug Administration. There is also no guarantee that the
product will prove to be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission.
Lilly undertakes no duty to update forward-looking statements.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO DATASOURCE: Eli
Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Tammy Hull of Lilly, +1-317-651-9116, ; or Pam DeMala of
Boehringer Ingelheim, +1-203-798-4700,
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