TOVIAZ SUMMARY
Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is a muscarinic receptor antagonist.
Toviaz® is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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NEWS HIGHLIGHTS
Published Studies Related to Toviaz (Fesoterodine)
Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder. [2011.11] AIMS: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study... CONCLUSION: A rapid and robust response to fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose. Copyright (c) 2011 Wiley Periodicals, Inc.
Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. [2011.05] CONCLUSION: The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.
Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms. [2011.05] CONCLUSIONS: Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.
Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial. [2011.05] OBJECTIVE: * To show the superior efficacy of fesoterodine over tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes... CONCLUSIONS: * In this randomized study, which is the largest to compare antimuscarinic efficacy performed to date, fesoterodine 8 mg was superior to tolterodine ER 4 mg for UUI episodes, micturitions and urgency episodes, as well as for self-reported patient assessments of bladder-related problems, urgency, symptom bother and health-related quality of life. * The superiority of fesoterodine 8 mg over tolterodine ER 4 mg was observed as early as 3 weeks after escalation from fesoterodine 4 mg for most outcomes. These data may have important implications for the clinical management of OAB patients previously treated with tolterodine ER. (c) 2010 THE AUTHORS. BJU INTERNATIONAL (c) 2010 BJU INTERNATIONAL.
Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial. [2010.09.21] Study Type - Therapy (RCT) Level of Evidence 1b OBJECTIVE: To show the superior efficacy of fesoterodine over tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes... CONCLUSIONS: In this randomized study, which is the largest to compare antimuscarinic efficacy performed to date, fesoterodine 8 mg was superior to tolterodine ER 4 mg for UUI episodes, micturitions and urgency episodes, as well as for self-reported patient assessments of bladder-related problems, urgency, symptom bother and health-related quality of life. The superiority of fesoterodine 8 mg over tolterodine ER 4 mg was observed as early as 3 weeks after escalation from fesoterodine 4 mg for most outcomes. These data may have important implications for the clinical management of OAB patients previously treated with tolterodine ER. (c) 2010 THE AUTHORS; BJU INTERNATIONAL (c) 2010 BJU INTERNATIONAL.
Clinical Trials Related to Toviaz (Fesoterodine)
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition [Recruiting]
The objective of the study is to find out if the medicine fesoterodine is a useful treatment
in children with bladder muscle overactivity caused by a neurological condition. Children
will be aged 6 to 17 years old. This is done by finding out how well it works, what the body
does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It
will be compared with the medicine oxybutynin, which is already available for treating the
condition.
Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder [Completed]
This is an open-label extension study intended for subjects who have previously completed
study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the
investigator as being suitable for the extended use of Fesoterodine. Data from this study
will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older
subjects from Portugal.
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity. [Recruiting]
The purpose of this study is to investigate the safety and tolerability of fesoterodine
following once daily long-term treatment in Japanese pediatric neurogenic detrusor
overactivity (NDO) subjects.
A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment [Not yet recruiting]
The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses
versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older
people with overactive bladder and mild cognitive impairment.
Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children [Enrolling by invitation]
Reports of Suspected Toviaz (Fesoterodine) Side Effects
Drug Ineffective (164),
DRY Mouth (145),
Constipation (107),
Pollakiuria (65),
Urinary Retention (58),
Dizziness (50),
Urinary Incontinence (44),
Vision Blurred (44),
Dysuria (33),
Malaise (29), more >>
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Page last updated: 2011-12-09
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