TY - JOUR 
A1 - Khullar, V.
AU - Amarenco, G.
AU - Angulo Cuesta, Javier
AU - Blauwet, M.B.
AU - Nazir, J.
AU - Odeyemi, I.A.
AU - Hakimi, Z.
T1 - Patient-reported outcomes with the β3 -adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder
Y1 - 2016
SN - 0733-2467

UR - http://hdl.handle.net/11268/7296
AB - Aims: To assess patient-reported outcomes (PROs) in patients with overactive bladder (OAB) receiving the novel β3 -adrenoceptor agonist mirabegron. Methods: Data from a randomised, double-blind, controlled phase III trial in 1,987 patients aged ≥18 years with OAB symptoms for ≥3 months were analysed. Patients received placebo, mirabegron 50 or 100 mg/day, or tolterodine extended release (ER) 4 mg orally once daily for 12 weeks after a 2-week placebo run-in. Prespecified analysis of PROs (changes in OAB Questionnaire [OAB-q], Patient Perception of Bladder Condition [PPBC], and Work Productivity and Activity Impairment: Specific Health Problem [WPAI-SHP] instrument) in patients treated with mirabegron 50 mg/day, tolterodine ER 4 mg/day or placebo is reported. Post-hoc analyses of OAB-q, PPBC and the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) in patients who were incontinent at baseline are also reported. RESULTS: Significant improvements over placebo in OAB-q coping and concern from baseline to final visit were observed with mirabegron 50 mg/day. No significant improvements in these parameters were observed with tolterodine ER 4 mg/day. Mirabegron 50 mg/day significantly increased the proportion of patients showing a PPBC improvement over placebo. Mirabegron 50 mg/day also produced greater improvements in WPAI-SHP presenteeism and greater reductions in absenteeism and overall work impairment than placebo or tolterodine ER 4 mg/day. The impact of mirabegron 50 mg/day treatment on PROs in the incontinent population appears to be greater than that in the overall OAB population. Conclusions: At the approved dose of 50 mg/day, mirabegron significantly improves OAB patients' perception of disease and quality of life, independent of whether they are incontinent at baseline. Neurourol. Urodynam.
KW - Vejiga hiperactiva
KW - Calidad de vida
KW - Urologia
KW - Calidad de vida
KW - Tratamiento médico
LA - eng
ER -