NEW YORK (Reuters Health) Treatment for up to 24 months with fesoterodine (Toviaz; Pfizer Inc) may yield sustained improvement in bladder problems and health-related quality of life in adults with overactive bladder (OAB), suggest results of a post hoc pooled analysis of data from two open-label extension studies.
A high percentag of study patients (92%) were satisfied with the treatment and results were similar across gender and age groups, Dr. Con J. Kelleher, from St. Thomas’ Hospital, London, United Kingdom and colleagues note in BJU International, available online now.
OAB is a chronic condition and some patients will benefit from long term pharmacotherapy, Dr. Kelleher noted in an email to Reuters Health.
There doesn’t appear to be a recommended duration of treatment and most clinical trials are short-term (12 weeks), he added. Studies that have followed patients after cessation of short term treatment have shown that over 50% would like to recommence treatment.
Of 1,669 adults with OAB who completed the 12-week randomized, double-blind studies of fesoterodine (4 or 8 mg once daily), 890 (53%) were subsequently enrolled in the open-label extension studies and 439 (49%) continued treatment out to 24 months.
The researchers assessed changes in various patient-reported outcome measures from both double-blind and open-label baseline to treatment months 12 and 24 of open-label treatment.
Overall, the results showed treatment with fesoterodine (mainly at the 8-mg dose) for up to 24 months resulted in clinically meaningful and statistically significant improvements in measures of health-related quality of life and a reduction in the severity and frequency of bladder problems, they report.
Notably, there was a large decrease in the percentage of incontinent subjects between double-blind baseline and open-label baseline in both men and women and among all age groups, they say.
The duration of symptoms and quality of life impact of symptoms appear to be the best predictors for who needs long term symptom control, Dr. Kelleher commented. For these patients, long term treatment with fesoterodine appears to be a safe and effective option, he said.
The study was funded by Schwarz BioSciences GmbH and Pfizer Inc. Three of the authors are employees of Pfizer. Dr. Kelleher and one co-author are consultants to Pfizer.
Reference:
BJU International. 2011. Published online November 30, 2011.
