Eli Lilly and Company and Boehringer Ingelheim GmbH: Large-Scale Study in the British Journal of Urology International Shows more than One out of Three Women with Urinary Incontinence (UI) Suffer from Stress Urinary Incontinence (SUI)

PR Newswire/INDIANAPOLIS, Indiana and INGELHEIM, Germany - Two separate studies appear now on the British Journal of Urology International website, addressing the prevalence of stress urinary incontinence (SUI) and data on duloxetine, a new pharmaceutical treatment for this medical disorder currently under regulatory review. The first is a large cross-country study showing that 35 per cent of the 17,080 women analysed reported having urinary incontinence (UI). Thirty-seven per cent 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 the frequency of incontinence episodes (IEF) with comparable significant improvements in quality of life (I-QOL) in women suffering from SUI(2). Both studies will be published in the February print edition of the British Journal of Urology International. Prevalence study: SUI most common form of urinary incontinence among women The study gathered data using a postal survey to randomly selected women aged 18 years and older in France, Germany, Spain and the UK 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 reported having experienced UI, but over two-thirds of those affected had never consulted a health care professional for treatment. Increasing age, severity and duration of incontinence symptoms were shown to be associated with consulting a doctor(1). "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 centres, randomised 458 women ages 27 to 79 from seven countries including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain. The results showed that patients treated with 80mg of duloxetine experienced a median reduction of 54 per cent in the frequency of incontinence episodes (IEF), a primary measure of efficacy, compared to a median reduction of 40 per cent in the placebo group. This difference accounted to be both statistically and clinically significant. Besides, 59.5 per cent of duloxetine-treated women had a 50 to 100 per cent decrease in their IEF(2) compared with only 43.2 per cent of subjects in the placebo group. "The safety and efficacy data from this late-stage study provide evidence for the value of duloxetine as potentially the first widely approved drug for women suffering from stress urinary incontinence. This new drug offers the opportunity for women with SUI to rejoin the normal active life of the family without fear of leakage of urine, enabling them to once again enjoy physical activity and family life," said Dr. Richard J. Millard, Associate Professor of Urology, The Prince of Wales Hospital, Sydney, Australia, and lead investigator in the study. "Duloxetine could potentially fill an unmet medical need by providing a primary treatment option for women who seek a pharmaceutical treatment for their SUI," he added. Duloxetine treated patients showed significant quality of life Improvements Subjects in the duloxetine group also showed significant improvements in their Incontinence Quality of Life (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 specific symptoms of incontinence in women who suffer from this medical disorder. I-QOL evaluates the disorder in three relevant domains: avoidance and limiting behaviour, 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 was nausea, although it was usually mild to moderate and resolved within one week to one month in most patients. Other less prevalent 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 patients. About SUI and Duloxetine SUI is defined as the complaint of involuntary urine leakage upon effort or exertion, or on sneezing or coughing(3). Several risk factors or contributing variables to the development of SUI have been suggested over the last decade and include childbirth, obesity, constipation, pelvic organ prolapse or chronic coughing(4). Although common, SUI is a medical disorder that is not normal at any age. Unfortunately, in spite of its high prevalence, many women do not seek treatment because they are embarrassed. Presently available treatment options include behavioural therapy, pelvic floor muscle training (PFTM) and surgery. To date, there is no globally approved drug for the treatment of SUI. Duloxetine has been shown to be a potent and balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine(5), which are believed to play key roles in the normal closure of the external urethral sphincter, a striated muscle located at the bladder outlet, that prevents urine leakage. Duloxetine, by inhibiting this reuptake in the sacral spinal cord, increases neurotransmitter concentration resulting in increased activity of the nerve that in turn stimulates the external urethral sphincter. This stimulation is believed to increase the tone and contraction of the external urethral sphincter, thereby helping prevent accidental urine leakage during physical activity, coughing and sneezing. About 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 commercialise 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 only. 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 organisations. Headquartered in Indianapolis, IN., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available on www.lilly.com . Boehringer Ingelheim The Boehringer Ingelheim Corporation is one of the world's 20 leading pharmaceutical companies. 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 7.6 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 www.boehringer-ingelheim.com . References (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. 2003 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 randomised clinical trial. British Journal of Urology International, 2003 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 standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn, 2002;21(2):167-178 (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 per maggiori informazioni : Christine Van Marter of Eli Lilly and Company,

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