Randomized, Double-blind, Placebo-controlled Trial of Flexible-dose Fesoterodine in Subjects With Overactive Bladder

Flexible‐Dose Fesoterodine in Elderly Adults with Overactive Bladder: Results of the Randomized, Double‐Blind, Placebo‐Controlled Study of Fesoterodine in an Aging Population Trial

“…These results in this subgroup support those of the post hoc analysis of data from two randomized, fixeddose, placebo-controlled studies that indicated that the 4-and 8-mg doses of fesoterodine effectively treated OAB symptoms in individuals younger than 75, with the 8-mg dose being most effective in those aged 75 and older. 22 These findings, together with the high rate of dose escalation with fesoterodine in the present study and in previous flexible-dose fesoterodine studies, 20 suggest that some elderly adults require higher doses of medication to achieve effective relief of OAB symptoms, contrary to commonly held beliefs about drug treatment in elderly adults. 38 One potential limitation of this study is that the mean MMSE score of the participants at baseline was approximately 28 in both treatment groups, suggesting that the participants were functioning at a high level even though the inclusion criteria required a score of only 20.…”

“…The majority of adverse events were mild or moderate (fesoterodine, 94%; placebo, 98%). No meaningful mean change from baseline (fesoterodine, n = 374; placebo, n = 382) to week 12 (fesoterodine, n = 341; placebo, n = 356) in MMSE score was observed in the fesoterodine (0.24 AE 1.76) or placebo [19][20][21][22][23][24][25][26][27][28][29][30] in the placebo group. No clinically relevant changes from baseline were observed in vital sign measurements in either group.…”

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea

“…The most frequently reported AE was gastro-intestinal system disorders (6.6%, 207/3107). The common TEAEs found in this study, dry mouth and constipation, were generally consistent with those reported by previous clinical studies [12][13][14][15][16] . The majority of the AEs were mild (73.0%) or moderate (22.6%).…”

Flexible Dosing of Trospium Chloride for the Treatment of OAB – Results of a Non-Interventional Study in 4,092 Patients

“…Once-daily formulations have been developed for several anticholinergic agents in order to improve patient compliance and tolerability [16]; however the negative side of such formulations is that they only allow for fixed dosing. Nowadays, results of randomized, controlled clinical trials as well as open label, flexible-dose studies indicate the advantages of adaptable dosing, which allow a more personalized treatment [13][14][15]17]. This approach considers the individual sensitivity of the patient to the drug as well as the willingness to tolerate a certain degree of side effects.…”