Darifenacin substantially improves quality of life for people with overactive bladder symptoms


Darifenacin significantly improves important emotional, physical and social limitations associated with overactive bladder symptoms. Overactive bladder (OAB) affects almost one in six adults in Europe.

Monte Carlo, Monaco, 27 June 2004 – Darifenacin significantly improves important emotional, physical and social limitations associated with overactive bladder symptoms.1 This is according to new data presented at the World Health Organisation's 3rd International Consultation on Incontinence, Monte Carlo. Overactive bladder (OAB) affects almost one in six adults in Europe.2

These new data show that after 12 weeks treatment with darifenacin, people with OAB symptoms are more able to undertake household tasks, socialise, work and travel. They are also less likely to feel depressed, anxious or nervous, as demonstrated by improvements in the King's Health Questionnaire (a questionnaire designed to assess the impact of bladder problems on patient's quality of life).

"OAB symptoms can severely restrict people's lives. People with OAB find urgency - a sudden compelling desire to pass urine, which is difficult to defer - to be particularly bothersome. Less mobile people find this hard to cope with, as they require greater time to reach a toilet. This can cause patients to avoid leaving their home, which severely restricts their lives and can result in social isolation and depression," said Con Kelleher, Consultant in Obstetrics and Gynaecology at Guy's and St Thomas' Hospitals Trust, London, UK. "These new data show that darifenacin significantly improved the quality of life for people with OAB, enabling them to resume everyday activities and lead less restricted lives."

Today's data also highlight darifenacin's tolerability and safety; as central nervous system (CNS) and cardiovascular (CV) safety were comparable to placebo.1 Recent reports provide emerging evidence, however, that current marketed treatments may create CNS problems such as cognitive impairment, due to a blockade of the M1 muscarinic receptor, and somnolence (unnatural drowsiness).3,4,5

Anti-cholinergics are the treatment of choice for OAB and act on receptors that activate the detrusor muscle to achieve bladder control. Symptoms of OAB are urinary urgency, with or without urge incontinence (strong desire to empty the bladder with an involuntary loss of urine), urinary frequency (emptying the bladder eight or more times in 24 hours), and nocturia (awakening two or more times a night to empty the bladder). Darifenacin is a new M3 selective receptor antagonist in development for OAB, which is proven to reduce the number of weekly incontinence episodes by up to 77%.6 The main treatment-related effects were noted as being constipation and dry mouth that resulted in low discontinuation rates.

Regulatory applications for Enablex®/Emselex® (darifenacin hydrobromide) have been submitted to the US and European authorities for the once daily oral treatment of overactive bladder in doses of 7.5mg and 15mg. On 3 October 2003, the company received an approvable letter from the US Food and Drug Administration. Novartis expects approval of Enablex/Emselex globally in 2004.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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