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abstract

181 - ASSESSING QUALITY OF LIFE AND PERSISTENCE IN PATIENTS PRESCRIBED MIRABEGRON IN ROUTINE CLINICAL PRACTICE; RESULTS FROM A PAN-EUROPEAN NON-INTERVENTIONAL STUDY

181

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 [1],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 [2]. 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.
Conclusions:
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: [1] Neurourol Urodyn2014;33(1):17-30. [2] J Urol 2006;176:627.