Boehringer Ingelheim

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.

@@start.t1@@      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@@end@@

    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)

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