Mirabegron, a β3-adrenoreceptor agonist, has shown 12-month safety, tolerability, and persistence of effect in patients with overactive bladders (OABs), show study findings.
The therapy demonstrated an acceptable safety and tolerability, with improvements in OAB developing after one month and lasting for 12 months, write researchers in European Urology.
The β3-adrenoreceptors are located in detrusor muscle and facilitate urine storage by inducing detrusor relaxation.
In the 12-month trial, which included 812 patients with OAB, administration of mirabegron 50 mg, mirabegron 100 mg, or an active control - tolterodine extended release (ER) 4 mg - reduced the mean number of micturitions per 24 hours from baseline to a similar extent - by 1.27, 1.41, and 1.39, respectively at study end. The incontinence episodes per 24 hours were also reduced, at respective means of 1.01, 1.24, and 1.26.
The percentage of individuals with at least a 50% reduction from baseline in the mean number of incontinence episodes per 24 hours was 63.7%, 66.3%, and 66.8% in the mirabegron 50 mg, mirabegron 100 mg, and tolterodine ER 4 mg groups, respectively, and the percentage of people with zero incontinence episodes in the corresponding groups was 43.4%, 45.8%, and 45.1%.
Treatment-emergent adverse events (TEAEs) were reported in 59.7%, 61.3%, and 62.6% of the three treatment groups of patients, respectively, with most being mild or moderate. And serious TEAEs were reported in a corresponding 5.2%, 6.2%, and 5.4% of patients.
"Overall, the data support the acceptable safety and tolerability profile of mirabegron in the treatment of OAB at a dose of 50 mg," say Christopher Chapple (Royal Hallamshire Hospital, Sheffield, UK) and colleagues.
"This is the first randomized active-controlled drug trial in patients with OAB to assess the 12-month safety and tolerability of once-daily mirabegron 50 and 100 mg in patients with OAB relative to that of tolterodine ER 4 mg."
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