Darifenacin in a real-world practice: results of a 6-month phase IV. trial

Abstract

Introduction: Patients often stop treatment and report adverse events when treated with drugs for overactive bladder (OAB). Which predictors influence compliance and treatment success was studied for M3 selective anticholinergic darifenacin in a real-world situation. Methods: Prospective observational multicentre 24-week phase IV trial. Patients with OAB were prescribed darifenacin. Adverse effects and compliance with treatment were evaluated. Treatment success was evaluated as change in the bother score on the 6-point scale for condition assessment. Results: 710 patients: 218 males, 492 females, mean age 61 years. 19.2 % were either lost or reported no improvement, 48.2 % reported improvement by 1 or 2 grades and 32.7 % improved by 3 or more grades. Better treatment success was found among those with more problems (higher bother) and younger. Gender, previous exposure to anticholinergics or presence of adverse effects were not related to treatment success. 581 (81.8 %) of included patients were on treatment for the duration of the study and 542 (76.3 %) continued after 6 months. The most significant predictor for discontinuation of treatment was the presence of adverse events (reactions), others were age (younger tend to stop treatment) and duration of problems (those with shorter duration tend to stop). Grade of problems, previous anticholinergic or gender were not related to discontinuation of treatment. Adverse events were reported by 192 patients (27 %). Females reported adverse events more often than males. Duration or grade of symptoms and age were not related to adverse events. Conclusions: Darifenacin is equally effective in both genders. It is the first-choice anticholinergic and is also useful in cases where other anticholinergics fail.