DE Nunzio Cosimo, Nacchia Antonio, Gravina Carmen, Turchi Beatrice, Gallo Giacomo, Trucchi Alberto, DI Giacomo Ferdinando, Disabato Giuseppe, Franco Antonio, Rovesti Lorenzo, Lombardo Riccardo, Cicione Antonio, Tubaro Andrea
Department of Urology, Sant'Andrea Hospital, Rome, Italy -
IRCCS Oncological Referrence Center of Basilicata, Rionero in Vulture, Potenza, Italy.
Minerva Urol Nephrol. 2022 Dec;74(6):761-779. doi: 10.23736/S2724-6051.22.04849-2. Epub 2022 Jun 16.
Antimuscarinic (AM) and beta-3-agonist (B3A) treatment are the standard first-line pharmacological treatment used to manage overactive bladder (OAB) patients. Aim of our study was to analyze real-life data of adverse events related to AMs and B3A reported on Eudra-Vigilance (EV) Database.
EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of AEs for antimuscarinic and beta-3-agonist per category and severity until January 2021.
Overall, 2313 AEs were reported for oxybutinin, 5129 for solifenacin, 2483 for tolterodine, 3523 for fesoterodine, 787 for trospium, 621 for propiverine and 7213 for mirabegron. Urinary retention was higher for fesoterodine (43%) and tolterodine (23%) when compared to solifenacin (10%), mirabegron (11%) and oxybutinin (4%). Cognitive disorder was uncommon for all the analyzed drugs analyzed. Regarding anticolinergic AEs: vision blurred, dry mouth and constipation were higher for AMs when compared to mirabegron. Their prevalence was higher in female patients. Mirabegron presented a higher risk of hypertension (7%) when compared to oxybutinin (2%, P<0.01), solifenacin (2%, P<0.01), tolterodine (2%, P<0.01) and fesoterodine (1%, P<0.01); the rate of hypertension was higher in females (63%) than males (29%) (P<0.01). The risk of acute urinary retention was also significantly higher (15% vs. 10%, P<0.01) in older patients (>85 years).
Real life data is consistent with registry studies regarding the rate of AEs related to antimuscarinic and beta-3-agonist. However some differences were observed. Female patients present higher rates of AEs when compared to male patients. The risk of acute urinary retention was particularly evident in the octogenarians.
抗毒蕈碱（AM）和β-3-激动剂（B3A）治疗是用于管理膀胱过度活动症（OAB）患者的标准一线药物治疗方法。我们研究的目的是分析在欧洲药物警戒数据库（EV）中报告的与AM和B3A相关的不良事件的真实数据。
EV数据库是用于管理和分析在欧洲经济区（EEA）已获授权或正在临床试验中研究的药物疑似不良反应信息的系统。我们记录了截至2021年1月各类别和严重程度的抗毒蕈碱和β-3-激动剂的不良事件数量。
总体而言，奥昔布宁报告了2313例不良事件，索利那新报告了5129例，托特罗定报告了2483例，非索罗定报告了3523例，曲司氯铵报告了787例，丙哌维林报告了621例，米拉贝隆报告了7213例。与索利那新（10%）、米拉贝隆（11%）和奥昔布宁（4%）相比，非索罗定（43%）和托特罗定（23%）的尿潴留发生率更高。在所分析的所有药物中，认知障碍并不常见。关于抗胆碱能不良事件：与米拉贝隆相比，抗毒蕈碱药物的视力模糊、口干和便秘发生率更高。这些不良事件在女性患者中的发生率更高。与奥昔布宁（2%，P<0.01）、索利那新（2%，P<0.01）、托特罗定（2%，P<0.01）和非索罗定（1%，P<0.01）相比，米拉贝隆发生高血压的风险更高（7%）；女性（63%）的高血压发生率高于男性（29%）（P<0.01）。老年患者（>85岁）急性尿潴留的风险也显著更高（15%对10%，P<0.01）。
真实生活数据与关于抗毒蕈碱和β-3-激动剂相关不良事件发生率的登记研究一致。然而，也观察到了一些差异。与男性患者相比，女性患者的不良事件发生率更高。急性尿潴留的风险在八旬老人中尤为明显。
