ASSESSING QUALITY OF LIFE ANDPERSISTENCE IN PATIENTS PRESCRIBED MIRABEGRON IN ROUTINE CLINICALPRACTICE; RESULTS FROM A PAN-EUROPEAN NON-INTERVENTIONAL STUDY
R. M. FREEMAN1, R.GRILL 2, Z. KACHLIROVA 2, N. CHOUDHURY 3,A. STARI 3, M. HUANG 3;
1PlymouthHosp. NHS Trust, Plymouth, United Kingdom, 2Charles Univ.,Prague, Czech Republic, 3Astellas Pharma Europe Ltd,Chertsey, United Kingdom.
Introduction: Mirabegron, afirst-in-class β3-adrenoceptor agonist, is an alternative treatmentoption for overactive bladder (OAB). Although clinical trials haveestablished the efficacy and safety profile of mirabegron ,observational studies can provide evidence about patient outcomes inroutine clinical practice.
Objective: The primary objectiveof this prospective, non-interventional study - the first largeEuropean observational study on mirabegron - was to evaluate changefrom Baseline in quality of life (QoL) based on OAB questionnaire(OAB-q) subscales . Secondary objectives included evaluation oftreatment persistence, patient satisfaction, healthcare resourceutilisation and adverse events (AEs).
Methods: Patientsaged ≥18 years with OAB symptoms ≥3 months and prescribedmirabegron as part of routine clinical practice were invited toparticipate in this study. Patients were enrolled prior to start ofmirabegron treatment. Follow-up was for a period of 12 months withvisit windows of 2-4 months and 10-12 months. The median change fromBaseline in total OAB-q and its subscales (Health-related quality oflife [HRQoL] and Symptom bother scale) was assessed.
Results:Overall, 862 patients were enrolled from 9 European countries. Ofthose, 848 (98.4%) were included in the Safety Analysis Set (SAF; allpatients who received ≥1 dose of mirabegron during the study), 796(92.3%) in the Full Analysis Set (FAS; all enrolled patients whocompleted the OAB-q at Baseline and at ≥1 follow-up visit) and 452(52.4%) in the Per Protocol Set (PPS; all enrolled patients whocompleted the OAB-q at Baseline and receiving mirabegron at 10-12months). In the FAS, 73.7% were female, mean age was 61.2 years;47.7% of patients were ≥65 years. At Baseline, 51.9% of patientshad moderate OAB symptoms, 40.7% had severe OAB symptoms, 41.3% hadswitched from other OAB treatments, 42.2% were treatment naïve,10.1% were lapsed and 6.4% were on combination treatment. Symptombother and Total HRQoL scores improved from Baseline to 2-4 monthsand 10-12 months (Figure). In the FAS, the median change fromBaseline in OAB-q Symptom bother score was -15.0 and -17.5 at 2-4months and 10-12 months, respectively and the median change for HRQoLTotal score was 9.6 and 14.4 at 2-4 months and 10-12 months,respectively. Similarly, in the PPS, the median change from Baselinein OAB-q Symptom bother score was -15.0 and -21.3 at 2-4 months and10-12 months, respectively, and the median change in HRQoL Totalscore was 11.2 and 17.6 at 2-4 months and 10-12 months, respectively.Observed persistence was high, with 54.6% and 53.8% of FAS patientsremaining on mirabegron at 2-4 months and 10-12 months, respectively.Overall, 42.8% of SAF patients reported ≥1 AE, 7.5% had ≥1serious AE, 21.0% had ≥1 mirabegron-related AE and 1.8% of patientsreported ≥1 mirabegron-related serious AE.
Thisprospective, non-interventional observational study showed thatpatients receiving mirabegron reported meaningful improvements inQoL. This might explain the high persistence, of 53.8%, at 1year.
This study was funded by Astellas Pharma EuropeLtd
References:  Neurourol Urodyn2014;33(1):17-30.  J Urol 2006;176:627.