Clinical Efficacy, Safety, and Tolerability of Once-Daily Fesoterodine in Subjects with Overactive Bladder

• Published in: European urology Vol. 52; no. 4; pp. 1204 - 1212
• Main Authors: Chapple, Christopher, Van Kerrebroeck, Philip, Tubaro, Andrea, Haag-Molkenteller, Cornelia, Forst, Hans-Theo, Massow, Ute, Wang, Joseph, Brodsky, Marina
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.10.2007; Elsevier
• Subjects: Adult; Aged; Benzhydryl Compounds - therapeutic use; Biological and medical sciences; Cresols - therapeutic use; Double-Blind Method; Female; Fesoterodine; Humans; Male; Medical sciences; Micturitions; Middle Aged; Muscarinic Antagonists - therapeutic use; Nephrology. Urinary tract diseases; OAB; Patient Selection; Phenylpropanolamine - therapeutic use; Safety; Tolterodine Tartrate; Urgency incontinence; Urinary Bladder, Overactive - classification; Urinary Bladder, Overactive - drug therapy; Urinary Bladder, Overactive - physiopathology; Urinary Incontinence - epidemiology; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urination - drug effects; Urination - physiology; Urology; OAB; Fesoterodine; Micturitions; Urgency incontinence; Human; Nephrology; Urinary system disease; Toxicity; Treatment efficiency; Urinary tract disease; Urology; Urinary incontinence; Voiding dysfunction; Cholinergic receptor; Micturition; Overactive bladder; Muscarinic receptor; Bladder disease; Antagonist; Daily dose
• ISSN: 0302-2838
• DOI: 10.1016/j.eururo.2007.07.009

To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB). This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (≥18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4mg, fesoterodine 8mg, or tolterodine ER 4mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24h and Treatment Response (“yes” or “no,” based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes. At the end of treatment, subjects taking fesoterodine 4 and 8mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8mg at most end points. Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8mg compared with the other treatments. Active treatments were well tolerated. Fesoterodine 4 and 8mg significantly improved OAB symptoms compared with placebo, as did tolterodine ER. On most end points, fesoterodine 8mg had a more pronounced effect compared with the other active treatments. Active treatments were well tolerated.