LONDON, Aug 28, 2008 (PR Newswire Europe via COMTEX) -- Pfizer Limited has
launched Toviaz(R)(Black Triangle Drug) (fesoterodine fumarate), a new once
daily treatment for the symptoms of overactive bladder (OAB). OAB is a condition
which affects an estimated 4.9 million people in the UK(1) (more than twice the
number of people with diabetes(2)) and has been shown to have a serious and
detrimental effect on people's emotional, psychological and sexual wellbeing(3).
Fesoterodine is an antimuscarinic drug which works by relaxing the muscles found
in the wall of the bladder, decreasing sudden uncontrollable bladder
contractions and increasing bladder capacity.(4) In two 12 week long,
international clinical trials, fesoterodine significantly improved the symptoms
of OAB compared to placebo(5),(6) (at least three quarters of patients said
their condition improved or greatly improved on the medicine compared with 53%
on placebo)(5) and patients taking fesoterodine also showed significant and
consistent improvement in health related quality of life (HRQL) compared to
placebo(7). This is important as OAB has a significant impact on quality of
life, often causing sufferers to stop many of the social and physical activities
they previously enjoyed and preventing them from leading a 'normal' life(3).
Fesoterodine is available as a 4 mg and 8 mg prolonged-release tablet(8). In
trials, initial treatment effect was seen as early as two weeks after the start
of therapy with fesoterodine. In addition, the medicine was generally well
tolerated(9). Dry mouth was the most commonly reported adverse event(5),(6).
Overactive bladder occurs when the detrusor muscle that controls emptying of the
bladder contracts involuntarily, creating a strong, sometimes uncontrollable
urge to urinate. Key symptoms include frequency (needing to pass water more than
eight times per day); urgency (the sudden desire to pass urine), and sometimes
urge incontinence (leaking or wetting oneself due to complete or partial loss of
bladder control)(10). People with an overactive bladder may pass urine as often
as 12 times a day or more(5).
OAB can cause significant emotional, psychological and physical problems(3). Yet
40% of people with OAB never seek medical help, usually because they believe
that it is an inevitable part of ageing and that no effective treatment is
available(10). Lesley Woolnough, Executive Director of Incontact, the UK
advocacy charity for people living with bladder and bowel control problems, said
"We welcome any new treatment that comes to the market that may potentially
improve the quality of life for people living with overactive bladder."
Karen Logan, Nurse Consultant and head of Continence Services for Gwent NHS
Healthcare Trust said "Incontinence still has a huge stigma attached to it and
many patients feel isolated and suffer in silence with it for many years. As
healthcare professionals we need to challenge the stigma and consider new ways
of raising awareness and encouraging patients to seek help and take control of
their condition."
Notes to editors
- During phase III studies with Toviaz(R), the King's Health Questionnaire (KHQ)
and the International Consultation on Incontinence Questionnaire-Short Form
(ICIQ-SF) were used to determine health related quality of life. The KHQ
comprises nine domains and assesses the impact of incontinence on physical and
emotional wellbeing. Scores range from 0 (best) to 100 (worst). The ICIQ-SF
assesses urinary frequency and urinary leakage and the effects on daily life and
scores range from 0 (low bother) to 21 (maximum bother).
- Incontact is the leading UK advocacy charity which campaigns for people living
with bladder & bowel control problems. Dedicated to raising awareness and
improving the understanding of continence issues, they provide user-friendly
booklets and fact sheets, offer an on-line support forum, a specialist nurse and
counsellor helpline and a magazine three times a year. Call confidentially on
+44(0)1536-533255, email info@incontact.org or visit http://www.incontact.org.
Registered charity number 1085095.
About Pfizer:
Pfizer Inc, the world's largest research-based pharmaceutical company,
discovers, develops, manufactures and markets prescription medicines in 11
therapeutic areas including oncology, cardiovascular, pain, neuroscience and
infectious diseases, including HIV/AIDS. Pfizer is also the world's largest
animal health company.
Pfizer Inc employs approximately 90,000 colleagues worldwide, all of whom are
devoted to working for a healthier world. Pfizer conducts more biomedical
research than any other organisation, and has 12,000 professionals working in
six major R&D sites worldwide, including Sandwich in Kent. Pfizer's annual UK
R&D investment is more than GBP550 million - more than GBP10 million a week.
In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK
business headquarters in Surrey, and is the major supplier of medicines to the
NHS.
References
1. Milsom I, Irwin DE, Kelleher C, Reilly K, Bridge SM. Prevalence of urinary
incontinence and overactive bladder: UK results from the EPIC study. (Abstract
337). Int Urogynecol J 2006; 17 (Suppl. 2): S57-S100
2. Diabetes: State of the Nations 2006. Progress made in delivering the national
diabetes frameworks. A report from Diabetes UK.
3. Nitti V W. Clinical impact of overactive bladder. Rev Urol. 2002;4(suppl
4):S2-S6
4. BNF 55. March 2008
5. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical efficacy, safety and
tolerability of once-daily fesoterodine in subjects with overactive bladder.
European Urol 2007;52:1204-1212
6. Nitti V, Dmochowski R, Sand PK et al. Efficacy, safety and tolerability of
fesoterodine for overactive bladder syndrome. J Urol 2007;178:2488-2494
7. Tubaro A, Wang J, Kopp Z, Bavendam T. Improvements in health-related quality
of life with fesoterodine in subjects with overactive bladder: pooled data from
two randomised controlled studies. ICS 2007. Abstract 462.
8. Summary of Product Characteristics: Toviaz 4 mg & 8 mg prolonged-release
tablets
9. Khullar V, Rovner ES, Dmochowski R et al. Fesoterodine dose response in
subjects with overactive bladder syndrome. Urol 2008;71:839-843
10. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an
overactive bladder and how are they managed? A population-based prevalence
study. BJU Int. 2001;87(9):760-766.
CONTACT: For further information please contact: Emma Coughlan / Sarah Ackers, Galliard
Healthcare, Tel: +44(0)20-7663-2281 / 2262, E-mail: ecoughlan@galliardhealth.com
; Andy Widger, Pfizer Ltd, Tel: +44(0)1737-330909, E-mail:
Andrew.Widger@pfizer.com .
Copyright (C) 2008 PR Newswire Europe
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