Comparison of fesoterodine and tolterodine in patients with overactive bladder

Abstract

primary endpoints (UUI episodes/24 h and treatment response), several secondary endpoints (severe urgency plus UUI per 24 h, mean VV (MVV)/void, and continent days/ week), HRQoL, using the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and self-reported bladder-related problems. A subanalysis also assessed all endpoints for patients who were incontinent at baseline. Tolerability and safety were assessed by evaluating adverse events, residual urine volume, laboratory variables and treatment withdrawals. RESULTSBy week 12, patients with OAB in both active-treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo. Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes, severe urgency plus UUI, mean VV, and number of continent days/week. In addition, the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group, with positive changes in most domains of the KHQ and an improvement in ICIQ-SF score. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. A major improvement in the severity of bladder-related problems was reported by 39% of the fesoterodine 8 mg and 34% of the tolterodine ER groups vs 25% of those on placebo ( P ≤ 0.01). Results for the subgroup of incontinent patients at baseline were similar to the overall results. Adverse events reported most commonly with active treatment included dry mouth, constipation, dry eye, dry throat, and nausea. CONCLUSIONSBoth fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL, with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints. KEYWORDSoveractive bladder, incontinence, quality of life, antimuscarinic Study Type -Therapy (RCT) Level of Evidence 1b OBJECTIVETo compare, in a post hoc analysis of a phase III trial, the maximum recommended doses of fesoterodine (8 mg) and tolterodine (4 mg) for improving overactive bladder (OAB) symptoms and health-related quality of life (HRQoL), as fesoterodine effectively reduces OAB symptoms vs placebo. PATIENTS AND METHODSEligible patients with frequency ( ≥ eight voids/24 h) and either urgency ( ≥ six episodes over 3 days) or urgency urinary incontinence (UUI; ≥ three episodes over 3 days) were randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended-release (ER) 4 mg for 12 weeks; fesoterodine 4 mg data were published elsewhere. Patients completed a 3-day bladder diary in which they recorded the time of each void, voided volume (VV), and the severity of urgency. A post hoc inferential analysis was conducted on the primary endpoint (voids/24 h), the two co-

Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder

“…Although discontinuation rates appear higher in pregabalin treatment groups, these rates are comparable to AE-related discontinuation rates reported in previous OAB studies evaluating the safety of antimuscarinic treatment, 18,25,26 and are based on relatively small numbers of patients in this study.…”

Antimuscarinic Drugs: Review of the Cognitive Impact When Used to Treat Overactive Bladder in Elderly Patients

“…5-HMT appears to be less permeable across the BBB and may be a substrate for active transport by the P-glycoprotein transporter [15]. The drug does not require hepatic metabolism to become active and, compared to other drugs in this class, has less potential for pharmacokinetic variability in individuals with liver dysfunction [43,44]. While in theory fesoterodine should have a low risk for adverse CNS effects, it has not been formally evaluated in a clinical trial to determine the rate of cognitive impairment in elderly patients with OAB.…”

Anticholinergics for urge incontinence

“…Fesoterodine was significantly better than tolterodine for improving urinary incontinence and episodes of severe urgency, and significantly better than the placebo group in QOL outcome measures. 53 No dosage reduction is required in renal or hepatic impairment. 54 Imidifenacin has higher affinity for M 1 and M 3 muscarinic receptors, making it more selective for the bladder compared with the salivary gland.…”