{"title":"Vibegron 对日本膀胱过度活动症患者的安全性和有效性:日本上市后调查","authors":"Shoko Yoshimura, Hiromitsu Yagi, Kazunori Abe, Masakazu Yamasaki","doi":"10.1111/luts.12535","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objectives</h3>\n \n <p>To evaluate the safety and effectiveness of vibegron, a highly selective β<sub>3</sub>-adrenoceptor agonist, in Japanese patients with overactive bladder (OAB) in a real-world clinical setting.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This 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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of 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.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This 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.</p>\n </section>\n </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/luts.12535","citationCount":"0","resultStr":"{\"title\":\"Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey\",\"authors\":\"Shoko Yoshimura, Hiromitsu Yagi, Kazunori Abe, Masakazu Yamasaki\",\"doi\":\"10.1111/luts.12535\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objectives</h3>\\n \\n <p>To evaluate the safety and effectiveness of vibegron, a highly selective β<sub>3</sub>-adrenoceptor agonist, in Japanese patients with overactive bladder (OAB) in a real-world clinical setting.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Of 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>This 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.</p>\\n </section>\\n </div>\",\"PeriodicalId\":18028,\"journal\":{\"name\":\"LUTS: Lower Urinary Tract Symptoms\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2024-11-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/luts.12535\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"LUTS: Lower Urinary Tract Symptoms\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/luts.12535\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"LUTS: Lower Urinary Tract Symptoms","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/luts.12535","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey
Objectives
To evaluate the safety and effectiveness of vibegron, a highly selective β3-adrenoceptor agonist, in Japanese patients with overactive bladder (OAB) in a real-world clinical setting.
Methods
This 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.
Results
Of 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.
Conclusions
This 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.
期刊介绍:
LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided.
LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.