ArticleLower urinary tract symptoms2024
Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey.
Article in Lower urinary tract symptoms, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Efficacy and Safety of Vibegron Add-On Therapy for Persistent Overactive Bladder Symptoms in Benign Prostatic Hyperplasia Patients With αLower urinary tract symptoms · 2026Trial
- Prescribing Patterns and Treatment Persistence for Overactive Bladder in Japan Across Medical Specialties and Facility Types: A Nationwide Claims Database Study.International journal of urology : official journal of the Japanese Urological Association · 2026Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
objectivesTo evaluate the safety and effectiveness of vibegron, a highly selective β
methodsThis prospective survey was conducted from August 2019 to July 2023 using a central registration method. Patients newly treated with vibegron for OAB were followed for 12 weeks, and those who continued treatment were observed for up to 52 weeks. Adverse drug reactions (ADRs) and the overall improvement level were assessed, and overactive bladder symptom score (OABSS) and International Prostate Symptom Score-Quality of Life (IPSS QOL) score were collected.
resultsOf the 1848 patients in the safety analysis set, 154 ADRs were reported in 141 patients (7.63%). Common ADRs were increased residual urine volume (1.30%), constipation (1.14%), dysuria and urinary retention (0.97% each), cystitis (0.65%), and dry mouth (0.32%). The incidence of urinary retention-related adverse events (AEs) was higher in male patients, patients ≥ 65 years old, and patients with benign prostatic hyperplasia. The effectiveness rate was 88.8% among the 1561 patients in the effectiveness analysis set. Significant improvement in both OABSS and IPSS QOL scores was observed at all observation periods. The rate of achieving the minimal clinically important change in OABSS total score at the final evaluation was 75.35%. OABSS scores were also significantly reduced in all subgroup analyses.
conclusionsThis survey found no major concerns regarding the safety and effectiveness of vibegron in Japanese OAB patients, except for urinary retention-related AEs. Vibegron is considered to represent a useful drug for treating OAB symptoms in a real-world clinical setting.
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