fesoterodine and Hypertension

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.

Topics: Aged; Aged, 80 and over; Female; Humans; Hypertension; Male; Muscarinic Antagonists; Solifenacin Succinate; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Retention

Topics: Aged; Benzhydryl Compounds; Female; Humans; Hypertension; Muscarinic Antagonists; Urinary Bladder, Overactive

To assess fesoterodine treatment in elderly women with overactive bladder with and without hypertension.. Data for 2527 elderly women with overactive bladder symptoms, including urgency urinary incontinence, were pooled from 10 double-blind, placebo-controlled fesoterodine studies.. A total of 1523 elderly women (60.3%) had a history of hypertension, and 1004 women (39.7%) had no hypertension history. Overactive bladder symptoms, mean bodyweight and mean body mass index at baseline were significantly higher in women with overactive bladder and hypertension versus those without hypertension (P < 0.05). Statistically significant improvements in overactive bladder symptoms at week 12 were observed for fesoterodine treatment versus placebo in women with hypertension and those without (P < 0.05). The diary-dry rate (no urgency urinary incontinence episodes), the proportion with less than eight micturitions/24 h, overactive bladder symptom bother and health-related quality of life were also statistically significantly improved by fesoterodine treatment in both populations. Incidence of treatment-related adverse events with fesoterodine was similar in women with hypertension (39.3%) and without hypertension (44.6%). Dry mouth and constipation were the most common treatment-related adverse events with fesoterodine in women with hypertension (26.2% and 5.2%, respectively) and without hypertension (30.5% and 8.0%).. A relationship among the severity of overactive bladder symptoms, hypertension and obesity in elderly women is suggested. Fesoterodine provides significantly greater improvements in overactive bladder symptoms and health-related quality of life versus placebo in women with or without hypertension. Hypertension does not appear to affect the efficacy and safety of fesoterodine in elderly women with overactive bladder symptoms, including urgency urinary incontinence.

Topics: Age Factors; Aged; Benzhydryl Compounds; Comorbidity; Constipation; Female; Humans; Hypertension; Incidence; Muscarinic Antagonists; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Xerostomia