Objective To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.Methods Participants of≥18 years with overactive bladder symptoms lasting for≥12 weeks,a m...Objective To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.Methods Participants of≥18 years with overactive bladder symptoms lasting for≥12 weeks,a mean of≥8 micturitions per 24 h,and a mean of at least one episode of Grade 3 or 4 urgency or urge incontinence per 24 h based on the Patient Perception of Intensity of Urgency Scale over a 3-day micturition diary period were randomized 2:1 to open-label treatment with oral mirabegron 50 mg or 25 mg once daily for 12 weeks(15 sites in China,January 2021–March 2022).A dose escalation from 25 mg/day to 50 mg/day was permitted at weeks 4 and 8 according to the investigators'discretion.The primary efficacy endpoint was the change from baseline to Week 12 in the mean number of micturitions per 24 h in those randomized to mirabegron 50 mg/day.Secondary efficacy endpoints were the change in mean number of micturitions at weeks 4 and 8 in the mirabegron 50 mg/day group and weeks 4,8,and 12 in the mirabegron 25 mg/day group,change from baseline to weeks 4,8,and 12 in Grade 3 or 4 urgency episodes on the Patient Perception of Intensity of Urgency Scale,episodes of daytime incontinence,nighttime incontinence,and urgency incontinence,and Overactive Bladder Symptom Score for mirabegron 50 mg/day and 25 mg/day groups.Results Statistically significant reduction(p<0.001)from baseline to Week 12 was observed in mean micturitions per 24 h for participants randomized to mirabegron 50 mg/day:mean±standard error:11.71±0.43 at baseline,7.80±0.24 at Week 12;adjusted mean change:−3.73(95%confidence interval−4.30 to−3.16).Both doses showed statistically significant improvement in secondary efficacy endpoints at weeks 4,8,and 12 versus baseline.Safety was consistent with mirabegron's known safety profile.Conclusion The results support a mirabegron dosage of 50 mg/day for the treatment of OAB in China.展开更多
文摘Objective To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.Methods Participants of≥18 years with overactive bladder symptoms lasting for≥12 weeks,a mean of≥8 micturitions per 24 h,and a mean of at least one episode of Grade 3 or 4 urgency or urge incontinence per 24 h based on the Patient Perception of Intensity of Urgency Scale over a 3-day micturition diary period were randomized 2:1 to open-label treatment with oral mirabegron 50 mg or 25 mg once daily for 12 weeks(15 sites in China,January 2021–March 2022).A dose escalation from 25 mg/day to 50 mg/day was permitted at weeks 4 and 8 according to the investigators'discretion.The primary efficacy endpoint was the change from baseline to Week 12 in the mean number of micturitions per 24 h in those randomized to mirabegron 50 mg/day.Secondary efficacy endpoints were the change in mean number of micturitions at weeks 4 and 8 in the mirabegron 50 mg/day group and weeks 4,8,and 12 in the mirabegron 25 mg/day group,change from baseline to weeks 4,8,and 12 in Grade 3 or 4 urgency episodes on the Patient Perception of Intensity of Urgency Scale,episodes of daytime incontinence,nighttime incontinence,and urgency incontinence,and Overactive Bladder Symptom Score for mirabegron 50 mg/day and 25 mg/day groups.Results Statistically significant reduction(p<0.001)from baseline to Week 12 was observed in mean micturitions per 24 h for participants randomized to mirabegron 50 mg/day:mean±standard error:11.71±0.43 at baseline,7.80±0.24 at Week 12;adjusted mean change:−3.73(95%confidence interval−4.30 to−3.16).Both doses showed statistically significant improvement in secondary efficacy endpoints at weeks 4,8,and 12 versus baseline.Safety was consistent with mirabegron's known safety profile.Conclusion The results support a mirabegron dosage of 50 mg/day for the treatment of OAB in China.
