Overactive Bladder (OAB) Clinical Trial
Official title:
Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron
The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on
therapy with antimuscarinics in patients with OAB treated with mirabegron.
The total duration of the study period was 54 weeks in total, comprising a 2-week screening
period and a 52-week treatment period. Patients who met the eligibility criteria for
provisional enrollment received orally the study drug for the screening period (mirabegron 50
mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after
the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2
mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and
antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for
tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or
imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the
study drugs; (2) was considered by the investigator to have no safety concerns; and (3)
agreed to increase the dose. However, in the event of AEs after the dose was increased, it
could be reduced to the level before the increase. A dose increase for a second time after
dose reduction was not permitted.
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