The objective of this study was to monitor and evaluate the persistence and cure effect of Mirabegron in patients with overactive bladder syndrome after 18 months of treatment.
Prospective clinical study.
10 gynecological and urological departments in CZE.
This is an analysis of a prospective, multicenter monitoring study from May to September 2014. The patients were 18 years old and had symptoms of OAB for a minimum of three months. Patient check-ups were performed 18 months after the first visit. The dosage of Mirabegron was 50 mg per day in 162 patients, though for 44 of the patients the treatment was changed. During the final check-ups it was ascertained how many patients had discontinued treatment with Mirabegron, at first as a proportion of the whole group of patients and then in relation to gender, age, previous treatment with anticholinergic drugs and changes in the treatment during the study. To evaluate treatment efficacy we employed the TS-VAS and PPBC. During the check-up it was ascertained how many patients had discontinued treatment with Mirabegron, and reasons for this were established. The statistics were calculated using the softwares STATISTICA 12 (Statsoft, USA) and SPSS 20.0 (IBM, v.20.0).
Prospective monitoring was performed on 206 patients. Their mean age was 62.8 years; mean body mass index for the whole group of patients was 27.3. At the check-up 18 months post-initiation of treatment it emerged that 79 (38.3%) patients had discontinued the treatment. The reasons for discontinuation of treatment were insufficient treatment efficacy (35.4% of patients), while 49.4% cited other reasons (hospitalisation, surgery, gravidity) and 15.2% of patients discontinued therapy because of side effects. The evaluation of treatment persistence with Mirabegron in groups with relation to gender, age and previous treatment with anticholinergic drugs did not establish statistically significant differences. However, there was a statistically significant difference between groups in relation to changes of treatment during study. At the evaluation of the efficacy of the treatment during the check-up 18 months after initiation of treatment the mean TS-VAS was 73.4, a decrease of the scale of bothers evaluated by PPBC before treatment from a mean value of 4.6 to a value of 2.7.
In our clinical study 18 months treatment persistence with Mirabegron was 61.7%. The reasons were reduced side effects and good cure effect of the drug.
Ceska gynekologie. 2017 Jan [Epub]
A Martan, J Mašata, K Švabík, T Hanuš, J Krhut, R Zachoval