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Fesoterodine at 4 or 8 mg Tops Placebo for Overactive Bladder Symptoms: Presented at EAU

By Jill Stein

MILAN, Italy -- March 28, 2008 -- The antimuscarinic agent fesoterodine at either a 4-or 8-mg dose reduces overactive bladder (OAB) symptoms, researchers reported here at the 23rd Annual European Association of Urology (EAU) Congress.

The results also demonstrate that the higher dose confers additional improvement for most bladder diary variables.

Vik Khullar, MD, Consultant Urogynaecologist, St. Mary's Hospital, London, United Kingdom, reported the results of an analysis of pooled data from 2 double-blind, placebo-controlled, phase 3 trials with a total of 1,674 patients with frequency and urgency or urgency urinary incontinence.

In each trial, patients were randomised to 12 weeks of treatment with fesoterodine 8 mg, fesoterodine 4 mg, or placebo. Subjects had to be at least 18 years of age at the time of enrolment, have OAB symptoms for at least 6 months, and have moderate bladder problems confirmed on a 6-point Likert scale. There were 554 patients on the 4-mg dose, 566 on the 8-mg dose, and 554 on placebo.

In each trial, subjects completed a 3-day bladder diary at baseline and at 2 and 12 weeks after starting treatment. The primary efficacy endpoints included diary variables and treatment response based on a 4-point Treatment Benefit Scale.

The 3 treatment groups were similar with respect to baseline clinical and demographic characteristics.

Results showed that by week 2, both fesoterodine doses significantly improved all endpoints compared with placebo except for total (OAB and non-OAB) urgency episodes (all P < .05).

By the end of treatment, both fesoterodine doses were associated with statistically significant improvements in all efficacy endpoints compared with placebo (P < .01).

The higher dose of fesoterodine was more effective than the lower dose in improving many diary variables, including UUI episodes, bladder capacity, and continent days per week (P < .05). This finding supports a dose-response relationship, Dr. Khullar noted in his presentation on March 27.

The most frequent treatment-related adverse events with fesoterodine 4 mg included dry mouth in 19% of patients and constipation in 4%. Dry mouth occurred in 35% of patients on the 8-mg dose and constipation occurred in 6%, compared with 7% and 2%, respectively, in placebo-treated patients. Most instances of dry mouth and constipation were mild to moderate in all patients who reported these effects.

Fesoterodine is a nonselective oral antimuscarinic agent that has been shown to reduce OAB symptoms. The agent is hydrolysed rapidly by nonspecific esterases to the active metabolite 5-hydroxymethyl tolterodine. After oral dosing, the parent compound is not detectable in plasma.

Funding for this study was provided by Pfizer Inc.

[Presentation title: Fesoterodine 4 and 8 mg Improves Symptoms of Overactive Bladder: Results From 2 Pooled Phase III Trials. Abstract 672]

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