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薬理と治療
Abstract
To assess the safety, tolerability and efficacy of long−term treatment(52 weeks)withimidafenacin 0.2 mg twice daily in overactive bladder(OAB)patients without safety concernand with insufficient effect of imidafenacin 0.1 mg twice daily(the standard dose). The studywas a multicenter, open−label trial. Patients who met eligibility criteria entered the study andreceived treatment with imidafenacin 0.1 mg twice daily for 12 weeks, and the dose of imidafenacinwas increased(to 0.2 mg twice daily)at week 12 if the patients met the dose increasecriteria, and if not, the dose was maintained. Imidafenacin were administered for total 52weeks(in the 0.1 mg twice daily arm)or 64 weeks(in the 0.2 mg twice daily arm). A total435 patients were enrolled in the study, 182 patients(41.8%)received an increased dose of0.2 mg twice daily and 153(84.1%)of them completed a year of 0.2 mg twice daily treatment.Imidafenacin 0.2 mg twice daily treatment was safe and well tolerated. The dose increase to0.2 mg twice daily further improved the number of urge incontinence episodes per week wasat week 16(4 weeks after the dose increase to 0.2 mg twice daily). This effect was sustaineduntil week 64(52 weeks after the dose increase), when the mean percentage change frombaseline in the number of urge incontinence episodes per week was −77.85% at week 64 ordiscontinuation. The dose increase to 0.2 mg twice daily also further improved urgency, micturitionand nocturia with OAB and furthermore Quality of Life(QOL), soon after the doseincrease, and the effects were maintained until week 64 or discontinuation, one year after thedose increase. Dry mouth and constipation were among the most frequent adverse eventsrelated to study medication. Dry mouth and constipation were reported by 26.5% and 9.9%of patients in the 0.1 mg twice daily arm and by 53.3% and 18.7% of patients in the 0.2 mgtwice daily arm, respectively. The majority of these events were mild in severity. There wasno clinically significant adverse effect with long−term treatment of imidafenacin 0.2 mg twicedaily. It is considered that in addition to imidafenacin standard dose(0.1 mg twice daily), adose increase to 0.2 mg twice daily, if the effect is insufficient, could provide an effective andsafe therapeutic opportunity to more OAB patients including patients who are not satisfiedwith the effect of the imidafenacin standard dose.(Jpn Pharmacol Ther 2009;37:909−30)KEY WORDS Imidafenacin, Overactive bladder, Efficacy, Safety, Long−term dose increasestudy, Quality of life(QOL)
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