“Efficacy and tolerability of fesoterodine fumarate in the treatment of overactive bladder symptoms in patients affected by Multiple Sclerosis: Long term follow up”.

fesoterodine fumarate has been already evaluated in the treatment of patients affected by symptoms of idiopathic overactive bladder (OAB) but no consistent data exist on the effects of the drug in OAB symptoms due to multiple sclerosis (MS). The aim of the present study was to evaluate the efficacy and tolerability of fesoterodine fumarate in a group of patients affected by MS and OAB symptoms in the long term follow up. MATERIAL & METHODS: From October 2009 to September 2011, 20 women and 9 men with MS and symptoms of OAB resistant to other anticholinergics were included in this prospective study. At baseline all patients underwent voiding diary (every day for one week), MS-specific quality of life questionnaire (MS-Qol-54) and urodynamics. All patients received fesoterodine fumarate 4 mg once daily. Voiding diary, MSQol- 54 and urodynamics were performed 1 month after the beginning of treatment and then twice a year. Primary endpoints of the study were: change from baseline in daily frequency of micturitions and urinary incontinence. Secondary endpoint was evaluation of dropout due to side effects or other problems. Eventual increase in the drug dosage to 8 mg once/daily whenever needed was considered. RESULTS: Mean ± SD follow-up was 22 ± 1.8 months. At 1 month follow up 22 patients (75.8%) showed a statistically significant decrease in frequency of micturitions (from 10.6 ± 3.8 to 7.7 ± 2.1; p<0.01) and urinary incontinence (from 1.8±1.7 to 1.2±0.8; p<0.05). Seven patients (24.1%) withdrew from the study due to adverse events (constipation and xerostomy). In 6 cases (20.6%) an alpha-blocker was added to treatment due to the development of post void residual volume clinically relevant. At 12 and 22 months after treatment, 16/22 patients (72.7%) mantained the reported improvement in urinary symptoms (frequency of daily episodes of urinary incontinence: 0.9 ± 1.0). Six patients discontinued therapy because of the cost of the drug. A global improvement in the QoL questionnaire was observed just at one month after treatment and was maintained during follow up. Drug dosage was increased to 8 mg once/daily in very few cases. CONCLUSIONS: The results of this study showed that fesoterodine fumarate 4 mg once daily was effective in the long term follow up of patients affected by MS and OAB symptoms. The rate of side effects inducing treatment discontinuation was contained and observed shortly after the beginning of treatment, mostly due to constipations and xerostomy. Interestingly, we noted a high rate of drop-out (27.24%) during follow up due to the cost of medication. Thus, treatment with fesoterodine fumarate 4 mg once daily is safe and effective in a high proportion of MS patients with OAB symptoms, but the cost of the drug plays an important role in the discontinuation of therapy.