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Aims To evaluate the safety and tolerability of the β3-adrenoceptor agonist, mirabegron, in patients with overactive bladder (OAB). Methods Tolerability and safety data from three 12-week, randomised, placebo-controlled, double-blind, Phase III trials (Studies 046, 047 and 074) were pooled by treatment group. The three studies were of a similar design, although the assessed doses of mirabegron [25, 50 or 100 mg once daily (qd)] varied, and tolterodine extended release (ER) 4 mg was included as an active-control arm in Study 046 only. Tolerability and safety data from a 1-year, randomised, double-blind, Phase III trial (Study 049) are also presented. Safety variables included the incidence and severity of treatment-emergent adverse events (TEAEs), vital signs and electrocardiogram data. Results Mirabegron (25, 50 or 100 mg qd) was safe and well-tolerated in patients with OAB over 12-week ( n = 2736) and 1-year ( n = 1632) periods. The incidence of TEAEs and treatment discontinuations as a result of TEAEs was low; the majority were mild in severity and few were serious. Hypertension, nasopharyngitis and urinary tract infection were the most common TEAEs with mirabegron. The mirabegron tolerability profile was similar to that seen with placebo and tolterodine ER 4 mg, except for dry mouth, which occurred, on average, five times less frequently with mirabegron than tolterodine ER 4 mg. In the pooled 12-week analysis, mirabegron 50 mg was associated with placebo-adjusted mean increases of 0.4-0.6 mmHg in blood pressure and approximately one beat per minute in pulse rate, both reversible upon treatment discontinuation. The incidence of Major Adverse Cardiovascular Events as adjudicated by an independent cardiovascular committee was low and similar across treatment groups. Conclusion The favourable tolerability profile of mirabegron in patients with OAB may allow improved treatment compliance compared with antimuscarinics, with important implications for patient outcomes. [ABSTRACT FROM AUTHOR]

Aim: In order to help physicians determine which drugs are the best for treating overactive bladder (OAB) symptoms, this review considered three questions: what are the patient's expectations? What information is generated by the Multicriteria Decision Analysis (MCDA) model? What can physicians expect from medical treatments?, Methods: A comprehensive literature search was undertaken on these three topics in order to assist physicians regarding the optimum treatment modality for OAB., Results: Patients' difficulties in reporting symptoms and their expectations of treatment outcomes interfere with the success of treatment. To assist physicians in meeting patients' expectations and to choose the most appropriate treatment, a new approach, recognised by the European Medicines Agency, the MCDA model was used to compare the benefits and safety of OAB treatments., Conclusion: The MCDA model is useful for comparing the benefit-safety profiles of OAB drugs in order to equip clinicians with information on the drug that might best meet their patient's needs. Flexibly dosed fesoterodine appeared to be most efficacious in resolving urgency and urgency incontinence compared with other drugs, and resolution of urinary urgency appears to be associated with a reduced number of reported adverse events., (© 2020 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.)

Introduction: Nocturia is a highly prevalent and bothersome medical condition characterised mainly by the need to wake up to pass urine during the main sleep period. Using data from wearable devices, it is possible to examine the sleep of large cohorts in natural settings. This study seeks to use data from connected smartwatches combined with a one-time survey to explore the presence of nocturia and associated level of bother and sleep characteristics in a non-patient cohort of wearable device users representing a broad age range., Methods: The data used come from a retrospective dataset containing sleep data from Withings watches of 250 000 users and a prospective dataset containing answers to a 10-item questionnaire completed by a subset of users in the retrospective dataset., Results: The prospective dataset contained 6230 users. Overall, 6.0%, 15.3% and 38.9% of users in the age groups 18-44 years, 45-64 years and 65-90 years, respectively, reported 2 or more nocturnal voids as their customary voiding pattern, corresponding to levels of nocturia consistent with previous literature. The level of bother associated with nocturia was higher among younger users with 27.8% of users aged 18-44 years reporting that their daytime activity was highly affected versus just 14.1% among those aged 65-90 years. A higher number of reported voids per night was associated with watch-derived measures of a lower sleep efficiency, a longer awake duration at night and a shorter first uninterrupted sleep period., Conclusion: This study suggests not only that nocturia is present among the younger population but also that the younger are more bothered by this medical condition. Using data from wearables it was possible to establish that there is an association between the number of nocturnal voids and sleep characteristics., (© 2020 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.)