The study, showed statistically significant reductions in incontinence episodes and micturition frequency (the co-primary endpoints) for mirabegron vs.
The symptoms were micturition frequency and incontinence episodes (the co-primary endpoints of the SCORPIO study), each of which had five levels of severity (Table 1).
Median change in number of micturitions
per day from baseline to trial end (primary end point) was significantly decreased in women on 4 mg fesoterodine (1.
Frequency was defined as at least eight micturitions in 24 hours; urgency urinary incontinence was defined as at least one episode in 24 hours.
The median change in number of micturitions per day from baseline to trial end (the primary end point) decreased significantly in the women on 4 mg fesoterodine (1.
However, at week 12, subjects receiving the combination therapy had significantly greater improvements versus placebo plus alpha-blocker in 24-hour micturitions
, daytime micturitions
, 24-hour urgency episodes, daytime urgency episodes, nocturnal urgency episodes, frequency-urgency sum, IPSS storage subscale, OAB-q symptom bother scale and OAB-q coping domain.
The median change in number of micturitions
per day from baseline to trial end (the primary end point) was significantly decreased for women on 4 mg fesoterodine (1.
It may also be that our population, with a baseline of eight micturitions
a day and five incontinence episodes a week, was not severe [enough] to have major social limitations and therefore would not have major improvements," Dr.
Primary aim: reduction of the micturition
The study showed that mirabegron significantly improves key OAB symptoms - urinary incontinence (leakage of urine) and frequency of micturition
(urination) compared with placebo.
21 March 2011 - Japan-based pharmaceutical company Astellas Pharma Inc (TYO: 4503) today announced the results of two pivotal Phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder (OAB), show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition