Phase II data of fesoterodine for the treatment of overactive bladder syndrome to be presented at the Congress of the International Continence Society (ICS), in Paris, France.
The results of a multinational, randomized, placebo-controlled phase II trial to investigate efficacy, tolerability and safety of fesoterodine in patients with overactive bladder syndrome (OAB) will be presented at the ICS conference in Paris, France.
Results demonstrated that fesoterodine significantly reduced symptoms of OAB. The observed treatment effect over placebo was significant and clinically relevant. Fesoterodine produced a reduction of the micturition frequency and number of incontinence episodes at first measurement after two weeks of treatment. The treatment was well tolerated, a release from Schwarz Pharma said.
"This trial indicates that fesoterodine is an efficacious anti-muscarinic agent which can rapidly and significantly improve symptoms in patients with overactive bladder syndrome," says Mr. Chris Chapple, Department of Urology, Royal Hallam-shire Hospital, Sheffield, UK, and principle investigator of this phase II trial.
"Fesoterodine appears to have a very good ratio between efficacy and side effects", Professor Iris Loew-Friedrich, member of the Executive Board of Schwarz Pharma said adding, "We do not expect a need for dose adjustments due to metabolism or concomitant medications. We are satisfied with the progression of the ongoing phase III clinical trials and we expect results in the second quarter of 2005."
In this multi-centre, multinational, double-blind, dose-ranging trial 728 patients with OAB were randomized. Patients received either placebo, fesoterodine 4mg, 8mg or 12mg for the duration of 12 weeks. A one-week placebo run-in period was followed by a 12-week double-blind treatment period.
There was a rapid improvement in both primary efficacy variables (micturition frequency and urge incontinence episodes) within the first two weeks of double-blind treatment over placebo. All three fesoterodine dose levels produced statistically significant changes from baseline to end of treatment compared with placebo in total number of voidings (number of micturitions plus number of incontinence episodes), frequency of micturitions per 24 hours, and in voided volume per micturition.
Patient's assessments of treatment tolerance, measured by the percentage of patients who rated their tolerance of the treatment as good or excellent, were 91 per cent, 83 per cent and 68 per cent in the fesoterodine 4mg, 8mg, and 12 mg groups, respectively compared with 92 per cent in the placebo group. The most favourable efficacy/safety ratios were observed in the 4mg and 8mg groups. The most frequently reported adverse event in the trial was dry mouth (placebo 9 per cent, 4mg 25 per cent, 8mg 26 per cent and 12mg 34 per cent). All other adverse events were in the range of placebo for all the treatment groups. Low rates were seen for constipation and vision disorders, which were in the placebo range.
Overactive bladder syndrome's main symptoms are urinary frequency and urgency, with or without incontinence. Anti-muscarinic agents such as fesoterodine are used to treat these symptoms. Approximately 10 per cent of the population over the age of 40, for most part women, suffers from this disease. Patients are often subject to social isolation due to the constant need to go to the restroom or even wetting themselves.