683 Randomised, double-blind, active-controlled phase III study to assess the long-term safety and efficacy of mirabegron in overactive bladder (OAB)

Mirabegron: a review of recent data and its prospects in the management of overactive bladder

“…The most frequent TEAEs were hypertension, dry mouth, constipation, and headache, which occurred at a similar incidence across all treatment groups, while the incidence of dry mouth was more than threefold lower compared with the tolterodine SR 4 mg group [Chapple et al 2012]. Most TEAEs were mild or moderate in severity across all treatment groups.…”

“…Incidentally, a thorough QT study showed no QT prolongation at the 50 mg dose [FDA, 2012]. Reprinted from [Chapple et al 2012], with permission from Elsevier. AE, adverse event; SR, sustained release.…”

“…Most frequent (≥2% in any treatment group) treatment-emergent adverse events (the TAURUS trial) Chapple et al 2012],. with permission from Elsevier.…”

Mirabegron – a selective ß3-adrenoreceptor agonist for the treatment of overactive bladder

“…Long term data is now available from a 52-week trial in which OAB subjects received either mirabegron 50 mg, 100 mg, or tolterodine SR 4 mg once daily 16. Efficacy variables included change in symptoms from baseline at 1, 3, 6, 9, and 12 months as collected in each patient’s micturition diary.…”

“…The primary safety variable from the year-long study16 was the incidence and severity of treatment-emergent adverse events. Discontinuations due to adverse events were 6.4%, 5.9%, and 6.0% in the mirabegron 50 mg and 100 mg and tolterodine 4 mg groups, respectively.…”