Cognitive Safety and Overall Tolerability of Imidafenacin in Clinical Use: A Long‐Term, Open‐Label, Post‐Marketing Surveillance Study

Sakakibara, Ryuji; Hamano, Hitoshi; Yagi, Hiromitsu

doi:10.1111/luts.12068

Cited by 15 publications

(6 citation statements)

References 29 publications

(44 reference statements)

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“…Drug‐related adverse events were reported in six patients in the TDI group, but no notable events were reported including cognitive function when compared with other reports . In addition, concomitant use of the anticholinergic resulted in an increase in PVR.…”

Section: Discussionmentioning

confidence: 60%

“…Drug-related adverse events were reported in six patients in the TDI group, but no notable events were reported including cognitive function when compared with other reports. 22 In addition, concomitant use of the anticholinergic resulted in an increase in PVR. This change was statistically significant, but was not considered clinically significant, and urinary retention was not reported, indicating relatively high overall safety of the TDI group.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (DIrecT Study)

et al. 2017

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Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (DIrecT Study)

et al. 2017

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“…When using anticholinergics, it is necessary to consider their effect on cognitive function. According to post‐marketing surveillance results of imidafenacin administration in patients with mild cognitive impairment (MCI), the conversion rate of MCI to dementia was 3.6%, which was not considered to exceed that reported in past epidemiological studies (6.8%‐16.1% per year). In the present study, no patients exhibited cognitive dysfunction, including memory disorder.…”

Section: Discussionmentioning

confidence: 82%

A 52‐week multicenter randomized controlled study of the efficacy and safety of add‐on dutasteride and imidafenacin to tamsulosin in patients with benign prostatic hyperplasia with remaining overactive bladder symptoms (DIrecT study)

Yamanishi

Asakura

Seki

et al. 2018

LUTS

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Objective: The aim of this study was to examine the long-term efficacy of combination of tamsulosin 0.2 mg + dutasteride 0.5 mg + imidafenacin 0.2 mg (TDI) therapy compared with tamsulosin + dutasteride (TD) therapy for 52 weeks in benign prostatic hyperplasia (BPH) patients with a prostate volume (PV) ≥30 mL and remaining overactive bladder (OAB) symptoms after having received tamsulosin for ≥8 weeks. Previously, we reported that the improvement in OAB symptoms at 24 weeks was significantly greater in the TDI than TD group.Methods: BPH patients with OAB symptoms after ≥8 weeks tamsulosin were randomly assigned to the TDI or TD group in a ratio of 1:1 ratio, and followed-up for 52 weeks. Changes in the OAB Symptom Score (OABSS), International Prostate Symptom Score (IPSS), and postvoid residual (PVR) were evaluated.Results: In all, 163 patients were randomized, and 125 patients (76.7%) completed 52 weeks of treatment. At Week 52, there were significant decreases in the OABSS and IPSS storage subscore compared with baseline in the TDI versus TD group, but the change in the total IPSS did not differ significantly between the two groups. There was no change in PVR from Week 24 toWeek 52 in either group.Conclusions: For BPH patients with PVR ≥30 mL and remaining storage symptoms despite tamsulosin monotherapy, TDI treatment showed better results in terms of improved OAB symptoms than TD treatment up to 52 weeks. K E Y W O R D S5α-reductase inhibitor, benign prostatic hyperplasia, cholinergic antagonist, combination therapy, long-term efficacy, overactive bladder

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“…Imidafenacin was not likely to affect cognitive function because CNS penetration was not observed in a PET study in vivo [44,57]; this is supported by the absence of published clinical studies showing cognitive impairment. In addition, clinical studies using imidafenacin in patients with mild cognitive impairment (MCI) and Alzheimer disease had no effect on cognitive function [69].…”

Section: Anticholinergicsmentioning

confidence: 99%

Cognitive Function and Urologic Medications for Lower Urinary Tract Symptoms

2020

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Special considerations should be made when selecting medications for the treatment of lower urinary tract symptoms (LUTS) in older patients especially those over 65 years old. This review summarizes the relationship between current treatments for LUTS and cognitive impairment. Although the recently reported association between dementia and tamsulosin is debatable, the effects of α-blockers and pharmacokinetics are not reported in this context. Five-alpha reductase inhibitors appear to affect mood. However, the association between the development of dementia and cognitive impairment is unlikely. Anticholinergic agents, other than trospium, fesoterodine, and imdafenacin have a relatively high distribution in the central nervous system. In particular, oxybutynin is reported to cause cognitive impairment. Several animal studies on the blood-brain barrier permeability of oxybutynin support this. Therefore, care must be taken when they are used in older patients (65 years and older). Beta-3 agonists are an alternative to, or may be used in combination with, anticholinergic drugs for patients with an overactive bladder (OAB). Several phase 2 and 3 clinical studies report high tolerability and efficacy, making them relatively safe for OAB treatment. However, there is a possibility that cognitive function may be affected; thus, long-term study data are required. We have reviewed studies investigating the correlation of urologic medications with cognitive dysfunction and have provided an overview of drug selection, as well as other considerations in older patients (65 years and older) with LUTS. This narrative review has focused primarily on articles indexed in PubMed, Google Scholar, Scopus, and Embase databases. No formal search strategy was used, and no meta-analysis of data was performed.

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Cognitive Safety and Overall Tolerability of Imidafenacin in Clinical Use: A Long‐Term, Open‐Label, Post‐Marketing Surveillance Study

Abstract: The present findings suggest that imidafenacin can be used safely for cognitively vulnerable patients with OAB.

Cited by 15 publications

References 29 publications

Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (DIrecT Study)

Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open‐label, controlled trial (DIrecT Study)

A 52‐week multicenter randomized controlled study of the efficacy and safety of add‐on dutasteride and imidafenacin to tamsulosin in patients with benign prostatic hyperplasia with remaining overactive bladder symptoms (DIrecT study)

Cognitive Function and Urologic Medications for Lower Urinary Tract Symptoms

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