A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder

Lee, K.-S.; Park, Bumsoo; Kim, J. H.; Kim, H. G.; Seo, Ju Tae; Lee, J. G.; Jang, Yong-Jun; Choo, Min Soo

doi:10.1111/ijcp.12272

Cited by 14 publications

(9 citation statements)

References 21 publications

(29 reference statements)

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“…These results of the reduction of micturition and UUI episodes indicate that imidafenacin achieves its antimuscarinic effect as early as 2 weeks after starting treatment and continues the efficacy to 12 weeks of treatment. Interestingly, the UUI reduction noted in this study is much lower than that in the pivotal trials performed in Japan and Korea 11,14,16,17 . The lower UUI episode reduction in this study may be attributable to the warmer climate of Taiwan as there could be less urine stored in the bladder in Taiwanese OAB patients compared with OAB patients in colder climates.…”

Section: Discussioncontrasting

confidence: 68%

“…Yokoyama et al also found imidafenacin not only reduced the number of nocturnal micturitions but also reduced nocturnal urine volume 26 . In Korea, treatment with imidafenacin 0.2 mg and fesoterodine 4 mg per day resulted in significant improvements in efficacy parameters, including frequency, urgency, UUI, nocturia, and quality of life 16 . Safety profile in imidafenacin was comparable as in the fesoterodine group.…”

Section: Discussionmentioning

confidence: 91%

“…Imidafenacin antagonizes bladder muscarinic receptors 13 . The long‐term safety, tolerability, and efficacy of imidafenacin have also been demonstrated in several subsequent studies 14‐17 . However, with the concern of serious adverse events (AE) of antimuscarinics, such as constipation, dry mouth, and cognitive dysfunction, the safety of imidafenacin still needs cautious evaluation.…”

Section: Introductionmentioning

confidence: 99%

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A double‐blind, randomized, placebo‐controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan

Chuang

Lin

Chow

et al. 2020

LUTS

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Objective: This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration. Methods: This randomized, double-blind, placebo-controlled, two-arm, parallelgroup, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups. Results: A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (−1.29 ± 2.23 vs-0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (−0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria. Conclusion: Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.

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Section: Discussioncontrasting

confidence: 68%

Section: Discussionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

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A double‐blind, randomized, placebo‐controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan

Chuang

Lin

Chow

et al. 2020

LUTS

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“…The incidence of AEs observed in this study was clearly lower than that in randomized double-blind trials (50-69%) 12,13,17 , indicating that fesoterodine was used safely in routine clinical practice. The possible explanations for this difference include a less stringent protocol for the PMS study compared to previous clinical trials.…”

Section: Discussioncontrasting

confidence: 51%

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea

Kim

Lee

et al. 2016

Current Medical Research and Opinion

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“…Twenty-three RCTs [11][12][13][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41] reported incontinence episodes/d, including a total of 14 treatment measures and a total sample size of 15,632 cases (supplementary Figure 1). Among these studies, since the inclusion criteria for the Dmochowski 2003 et al [51] .…”

Section: Mean Daily Incontinence Episodesmentioning

confidence: 99%

Comparative Assessment of Efficacy and Safety of approved Oral Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis

Huang

Cui

et al. 2023

Preprint

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Purpose To compare the effectiveness and safety of marketed oral drugs for the treatment of overactive bladder. Methods Pubmed, Embase, Web of Science, and The Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022, and randomized controlled double-blind trials of oral drugs for overactive bladder were screened. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 to compare and rank differences in effectiveness and safety. Result A total of 60 randomized controlled double-blind trials were included. Solifenacin 10mg was the most effective in micturitions and incontinence episodes, solifenacin 5/10mg in urgency and nocturia, fesoterodine 8mg in urgency incontinence and oxybutynin 5mg in voided volume/micturition. For safety, mirabegron, vibegron, solifenacin 5mg, extended-release tolterodine 4mg and extended-release oxybutynin 10mg all showed a better incidence of dry mouth; Compared to placebo, only imidafenacin 0.1mg, showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and controlled release darifenacin 15mg in headache. Conclusion Solifenacin showed better efficacy. For safety, most anticholinergics were more likely to cause dry mouth and constipation, while β-adrenergic agonists showed an increased incidence of nasopharyngitis. The choice of therapeutic agent should be tailored to the patient's situation in order to find the best balance between efficacy and safety.

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A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder

Abstract: Imidafenacin was non-inferior to fesoterodine in terms of efficacy, and showed no significant difference in terms of safety.

Cited by 14 publications

References 21 publications

A double‐blind, randomized, placebo‐controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan

A double‐blind, randomized, placebo‐controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea

Comparative Assessment of Efficacy and Safety of approved Oral Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis

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