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First of its Kind Urinary Incontinence Study Reveals Many Women With Stress Urinary Incontinence Symptoms Receive Off-Label Medications or None at All

Indianapolis and Ingelheim, Germany (ots/PRNewswire)

The
landmark PURE (Prospective Urinary Incontinence REsearch) study data
at baseline, presented today at IUGA (International Urogynecological
Association), show that many women with symptoms of stress urinary
incontinence (SUI) are receiving off-label medications or no
pharmaceutical treatment at all.(1) This may leave women afraid to
participate in normal daily activities for fear of accidental
leakages or may be unlikely to re-visit their healthcare professional
because they have lost all confidence.
Part of the study focuses on SUI which, with nearly twice the
prevalence of urge incontinence, is the most common form of urinary
incontinence (UI) in women, followed by mixed urinary incontinence.
Its symptoms include the accidental leakage of urine during physical
activities such as sneezing, coughing, laughing, lifting or
exercising.(2,3) SUI is an embarrassing and bothersome medical
condition, which affects one in seven women worldwide and can have a
significant impact on a woman's quality of life.(2,3)
The PURE study is the first European study to investigate the
economic and human impact of UI. Although the present release only
involves data at baseline, the study's primary objectives are to
understand the direct cost of UI, the impact of UI on health-related
quality of life, and understand the treatment patterns for women with
UI in Europe.(4,5) UI has been dubbed one of the "last medical
taboos" by the World Health Organization.(6)
"These data give an unrivalled insight into the patterns of
treatment of women with symptoms of stress urinary incontinence, many
of whom have put up with the problem for years," commented Dr. Adrian
Wagg, Consultant in Geriatric Medicine from University College
Hospital, London, UK and a principal investigator of the PURE study.
"Since these data were collected, we have an effective medication
available for the treatment of SUI symptoms. The data show the
importance of encouraging women to go to their doctors, to talk about
their symptoms and ask about new treatment options."
The data at baseline from the PURE study, from 9,487 enrolled
women with UI from 14 European countries, focus on prescribing
practices for all types of UI over a 12-month time period, prior to
the patient receiving her baseline diagnosis. The results for use of
medication show:
- There were considerable country differences in the prescribing
rates for UI overall, with women in the Netherlands the least likely,
and women in Germany the most likely, to receive any pharmaceutical
treatment (19% and 41%)
Specifically regarding the results in SUI:
  • One in four women presenting at baseline with SUI symptoms in Germany, Sweden and the UK had received a prescription for a UI medication (26.9%, 27.7% and 25.9%, respectively) -- the majority of which haven't show efficacy in SUI
  • Less than one in ten women in Spain and the Netherlands presenting with SUI symptoms at baseline had received a prescription for her SUI symptoms (9.9% and 8.9%, respectively)
  • Approximately a quarter of women presenting with SUI symptoms at baseline in Germany and the UK had received an anticholinergic -- a drug that is not indicated for the treatment of SUI symptoms (25.5% and 26.8%, respectively)
Carol, an SUI sufferer from the UK commented on the importance of
receiving effective treatment. "The emotional impact of living with
SUI was huge. It affected every aspect of my life, from going out
with friends to playing with my children. However, I found the
courage to go to my doctor, who gave me a medication called
Yentreve(R) that was right for me as it helped to control the
symptoms of my SUI. Today, I feel confident to go out with friends
and no longer feel that my life revolves around my SUI."
The PURE study enrolled women with UI from October 2003 to
February 2005, in a period where in most countries no medication was
approved and launched for SUI. The data presented at IUGA suggest
that relatively few SUI patients receive medication for their SUI and
for those who do receive a prescription, the majority of those
medications are not indicated for the treatment of SUI symptoms.
Results from three other published trials in women with SUI
demonstrated that Yentreve(R) (duloxetine hydrochloride)
significantly reduced the number of incontinence episodes and
improved patients' quality of life compared with placebo.(7)
Despite recent advances in UI,(8) there are still important areas
to explore further. One important aspect from the patients'
perspective is that timely access to UI medication is made available
across Europe with no out-of-pocket expenses. However, many health
care systems still place restrictions on the reimbursement of UI
medication, and SUI medication in particular, partly due to the lack
of understanding about the condition and its impact. When complete,
PURE will address relevant clinical, economic and policy research
questions and will provide large-scale, comparative, real-world
information on the treatment and burden of UI across Europe,(8) data
which is currently missing from the European literature but needed to
guide effective health policy. Look for more information on PURE in
2006 when the direct costs of UI will be confirmed.
    Notes to Editors:
    The different types of urinary incontinence and their symptoms are:(2)
    TYPE OF UI                 SYMPTOM
    Stress Urinary             - The complaint of involuntary leakage
    Incontinence  (SUI)(2)       during effort or exertion, or on sneezing
                                 or coughing
    Urge Urinary               - The complaint of involuntary leakage
    Incontinence  (UUI)(2)       accompanied by, or immediately preceded
                                 by, a sudden compelling desire to pass
                                 urine, which may be difficult to defer
    Mixed Urinary              - The complaint of involuntary leakage
    Incontinence  (MUI)(2)       associated with both SUI and UUI symptoms
PURE
PURE is a six-month observational study including 9,487 enrolled
women and 1,055 investigators from 14 European countries. At
baseline, information on the type of UI and treatment patterns in the
preceding 12 months was collected. UI type was classified according
to a two-question validated quantitative questionnaire, recording
symptoms of stress and urge incontinence.
SUI and its Symptoms
SUI symptoms are defined as the accidental leakage of urine during
physical activities such as sneezing, coughing, laughing, lifting or
exercising, and affect the social and emotional well-being of up to
65 million women worldwide.(6) With nearly twice the prevalence as
urge incontinence, SUI is the most common form of urinary
incontinence in women causing embarrassment, social isolation and a
reduction in quality of life. Despite being bothered by their
symptoms, women often do not seek appropriate medical attention
because they are embarrassed or mistakenly believe SUI symptoms are a
normal part of aging. Several risk factors or contributing variables
have been suggested for the development of SUI symptoms and include
childbirth, obesity, pelvic organ prolapse or chronic coughing.(9)
Yentreve(R) for the Treatment of SUI
Yentreve(R) is a balanced dual reuptake inhibitor of the
neurotransmitters serotonin and norepinephrine,(10) based upon
preclinical data; these neurotransmitters are believed to play key
roles in the normal closure of the urethral sphincter, the muscle
that if weakened can contribute to SUI.(10,11) By increasing
neurotransmitter concentration, Yentreve(R) is believed to increase
the tone and contraction of the urethral sphincter, which helps
prevent the symptoms of SUI. Yentreve(R) is the first and only widely
approved pharmaceutical treatment for SUI. Prior to Yentreve(R)'s
availability there was no widely approved pharmaceutical option
available for the treatment of SUI. Options were limited to
treatments such as behavioural therapy, PFMT and surgery.
In four multi-centre clinical trials involving nearly 2,000 women
performed in Africa, Australia, Europe, North America, and South
America, Yentreve(R) reduced the number of leakages by 50 percent to
100 percent in more than half of women with SUI as compared with 33
percent in placebo-treated patients. Yentreve(R) also helped improve
their quality of life, and was generally well tolerated with mild and
manageable side effects, the most common of which was transient
nausea.(11) Other common adverse events observed in the clinical
studies of Yentreve(R) for the treatment of SUI (incidence of greater
than 5 percent and significantly more common than placebo) were dry
mouth, fatigue, insomnia, constipation, headache, dizziness,
somnolence and diarrhea.(10) Other studies are planned and new
studies will be initiated as the clinical research program evolves.
Yentreve(R) has been studied in more than 10,000 patients and is
now approved throughout the 25 European Union countries, Mexico,
Switzerland, Norway and Israel. Yentreve(R) is available in Austria,
Denmark, Finland, Germany, Iceland, Ireland, Luxembourg, Mexico,
Norway, Sweden and the United Kingdom.(12) Eli Lilly and Company and
Boehringer Ingelheim plan to make Yentreve(R) available in many more
countries in the coming months. Furthermore, in Greece and Italy the
product is available under the trade names Yentreve(R) (marketed by
Lilly) and AriClaim(R) (marketed by Boehringer Ingelheim(i)).
Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim
signed a long-term agreement to jointly develop and commercialize
duloxetine hydrochloride. Duloxetine is currently being marketed for
the treatment of depression, stress urinary incontinence and diabetic
peripheral neuropathic pain. This partnership covers most countries
worldwide with few exceptions. In the USA, the collaboration excludes
neuroscience indications.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of 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.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 144 affiliates in 45 countries and nearly
36,000 employees. Since it was founded in 1885, the family-owned
company has been committed to researching, developing, manufacturing
and marketing novel products of high therapeutic value for human and
veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro
while spending nearly one fifth of net sales in its largest business
segment Prescription Medicines on research and development.
For more information please visit www.boehringer-ingelheim.com
(i) Note to Editors:
Duloxetine for stress urinary incontinence will be marketed by
Lilly and Boehringer Ingelheim in all countries included in the
partnership under the brand name Yentreve(R), except for Greece,
Italy, and Spain. In Greece, Italy, and Spain, Lilly will market the
product as Yentreve(R) and Boehringer Ingelheim will market the
product as AriClaim(R).
References
1. Papanicolaou S, Espuna-Pons M, Hampel C, et al. Prescribed
medication for the treatment of women with urinary incontinence in
Germany, Netherlands, Spain, Sweden and the United Kingdom. Results
from PURE (Prospective Urinary incontinence REsearch). Abstract
number 286 IUGA 2005
2. Abrams P, Cardozo L, Fall M, et al. The standardisation of
terminology of lower urinary tract function: report from the
standardisation sub-committee of the International Continence
Society. Neurourol Urodyn 2002;21(2):167-78
3. Fultz NH, Burgio K, Diokno AC, et al. Burden of stress urinary
incontinence for community-dwelling women. Am J Obstet Gynecol
2003;189:1275-82
4. Papanicolaou S, Hunskaar S, Lose G, Sykes D. Assessment of
bothersomeness and impact on quality of life of urinary incontinence
in women in France, Germany, Spain and the UK. BJU International
2005, in press
5. Papanicolaou S, Castro R, Espuna-Pons M, et al. Prospective
urinary incontinence research (PURE): Description of study, rational,
design and methodology. Value in Health 2004; 7(3):366.
6. Voelker R. International group seeks to dispel incontinence
"taboo". JAMA 1998;280(11):951-953
7. Zinner NR. Duloxetine: a serotonin-noradrenaline re-uptake
inhibitor for the treatment of stress urinary incontinence. Expert
Opin Investig Drugs 2003;12(9):1559-1566
8. Abrams P, Cardozo L., Khoury S, Wein A. 3rd International
Consultation on Urinary Incontinence. Volume 2. Edition 2005
9. Viktrup L. Female stress and urge incontinence in family
practice: insight into the lower urinary tract. Int J Clin Prac
2003;56(9):694-700
10. Bymaster FP, Dreshfield-Ahmad LJ, Threlkeld PG et al.
Comparative affinity of duloxetine and venlafaxine for serotonin and
norepinephrine transporters in vitro and in vivo, human serontonin
receptor subtypes, and other neuronal receptors.
Neuropsychopharmacology 2001;25(6):871-80
11. Hurley, Baygani, Simmons, Yalcin and Bump. Duloxetine for
stress urinary incontinence (SUI): Meta-analysis of safety. Abstract
presented at the International Federation of Gynaecology and
Obstetrics (FIGO) World Congress. Santiago, Chile. 2-7 November 2003
12. European Commission marketing authorisation announcement for
Yentreve(R) / Ariclaim(R) pharmacos.eudra.org (
pharmacos.eudra.org/F2/register/brand_full.htm)
(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/20050811/PURELOGO )

Contact:

Christine Van Marter of Eli Lilly and Company, +1-317-655-2249; or
Julia Meyer-Kleinmann of Boehringer Ingelheim GmbH,
+49-6132-77-82-71/ Photo: NewsCom:
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/20050811/PURELOGO ; PRN Photo
Desk, photodesk@prnewswire.com

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