Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder in a Real‐World Clinical Setting: A Japanese Post‐Marketing Study

Abstract

In the clinical setting, mirabegron is well tolerated, with no unanticipated ADRs, and is an effective treatment for Japanese patients with OAB.

Safety, efficacy, and persistence of long‐term mirabegron treatment for overactive bladder in the daily clinical setting: Interim (1‐year) report from a Japanese post‐marketing surveillance study

“…More than half (56.0%) of patients responded to treatment and 65.8% achieved the MCIC (OABSS decreased by ≥3 points at 1 year or final assessment). These findings are consistent with the results of a previous 12‐week mirabegron post‐marketing study, and the maintenance of overall mirabegron effectiveness over 1 year is also consistent with other long‐term studies conducted in Japan and Europe …”

“…The data reported herein are from one of four such surveillance studies comprising the mirabegron post‐marketing surveillance program. Two of these studies have been published to date, with the final study in progress …”

Long‐term safety and efficacy of antimuscarinic add‐on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study)

“…The trial was open label; a potential source of patient‐ and physician‐associated bias. In addition, 88.1% of the patients were women; a higher proportion than in previous SOLI and MIRA combination studies (66.4–83.9%) and post‐marketing Japanese investigations (50.5–53.2%) . Furthermore, we believe that an antimuscarinic drug should be added to a patient's therapeutic regimen if they experience an insufficient response to treatment with MIRA.…”

“…International urological associations recommend MIRA and antimuscarinics for treating patients with OAB symptoms . However, even when favorable results are achieved in clinical studies, poor responses might be noted in the real‐world setting . Poor responders to initial treatment might achieve an improved outcome if they subsequently receive MIRA and an antimuscarinic in combination.…”

Safety and effectiveness of mirabegron in patients with overactive bladder aged ≥75 years: Analysis of a Japanese post‐marketing study

“…Recently, we conducted a 12‐week post‐marketing study on Japanese patients with OAB initiating treatment with mirabegron in a routine clinical setting . Interestingly, the proportion of patients aged ≥65 years was >80%, which was higher than that reported in Japanese clinical studies, and nearly half of the patients (48.8%) were ≥75 years old.…”