1962 AGE, GENDER AND NOCTURNAL URGENCY SEVERITY PREDICT RESPONSE TO ANTIMUSCARINIC TREATMENT

Abstract

INTRODUCTION AND OBJECTIVES: Nocturnal urinary urgency significantly impacts quality of life in patients with overactive bladder. To date, only 1 prospective study has demonstrated antimuscarinic efficacy for reducing nocturnal urgency episodes. Data on predictors of positive treatment outcomes would help identify patients who would most likely benefit from antimuscarinic pharmacotherapy. We examined the impact of sex, age and baseline nocturnal urgency on the response to fesoterodine (FESO) in overactive bladder (OAB) subjects with nocturnal urgency. METHODS: Eligible subjects aged 18 years with self-reported OAB symptoms, including nocturnal urgency, were randomized to receive fesoterodine or PBO for 12 wk if they had 2-8 nocturnal urgency episodes/24 h at baseline and a 35% reduction of nocturnal urgency episodes during a 2-week, single-blind PBO run-in. Following 1:1 randomization, FESO 4 mg (n 463) or PBO (n 474) was administered once daily for 4 weeks, followed by optional escalation to 8 mg for the remaining 8 weeks at the discretion of the investigator. For this post-hoc analysis, a logistic regression model was used to assess whether treatment, sex, age and number of baseline nocturnal urgency episodes predicted the likelihood of response, defined as a reduction from baseline of 1 micturition-related nocturnal urgency episodes/24 h at week 12. Missing data were imputed with the last observation carried forward method. RESULTS: Nocturnal urgency episodes were significantly reduced following fesoterodine treatment (P 0.0034; Figure). Women (P 0.0225) were more likely to show a treatment response than men to respond to fesoterodine. Greater number of baseline nocturnal urgency episodes (P 0.0001) was also associated with an increased likelihood of treatment response. Older age (P 0.0123) was associated with a slightly decreased likelihood of treatment response. CONCLUSIONS: Treatment, sex, age, and number of nocturnal urgency episodes at baseline significantly predicted the likelihood of response in subjects with OAB and nocturnal urgency.