PMID- 29254376 OWN - NLM STAT- MEDLINE DCOM- 20190916 LR - 20190916 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 34 IP - 5 DP - 2018 May TI - Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study. PG - 785-793 LID - 10.1080/03007995.2017.1419170 [doi] AB - OBJECTIVE: Observational studies can provide evidence about patient outcomes in routine clinical practice. This prospective, non-interventional study (BELIEVE) is the largest real-world European study to date to assess quality-of-life, treatment satisfaction, resource utilization, and persistence in patients with overactive bladder (OAB) who were prescribed mirabegron as part of routine clinical practice. METHODS: The primary objective was to evaluate change from baseline in quality-of-life based on overactive bladder questionnaire (OAB-q) sub-scales. Secondary objectives included evaluation of treatment persistence, patient satisfaction, healthcare resource utilization and adverse events (AEs). Follow-up was for 12 months with visit windows at 2-4 and 10-12 months. Median change from baseline in total OAB-q and its sub-scales (Health-related quality-of-life [HRQoL] and symptom bother scale) were assessed. RESULTS: Overall, 862 patients were enrolled from eight European countries. In the Full Analysis Set (FAS), 73.7% were female, mean age was 61.2 years; 47.7% >/=65 years. At baseline, 41.3% had switched from other OAB treatments, 42.2% were treatment naive, 10.1% were lapsed, and 6.4% were on combination treatment. Symptom bother and HRQoL total scores improved from baseline to 2-4 and 10-12 months. There was a notable improvement in dry rate, increasing from 34.9% at baseline to 43.7% at 10-12 months in the FAS, and a reduction in pad use. Persistence was high, with 53.8% of FAS patients remaining on mirabegron at 10-12 months. Overall, no unexpected safety issues were observed and AEs were consistent with the known safety profile of mirabegron. CONCLUSION: Patients receiving mirabegron in a real-world setting reported meaningful improvements in QoL and health status, with a persistence rate of 53.8% at 12 months for the FAS. No unexpected safety issues were observed, and AEs were consistent with the known safety profile of mirabegron. FAU - Freeman, Robert AU - Freeman R AD - a Derriford Hospital , Plymouth , Devon , UK. FAU - Foley, Steve AU - Foley S AD - b Royal Berkshire Hospital , Reading , Berkshire UK. FAU - Rosa Arias, Jose AU - Rosa Arias J AD - c Department of Urology , Hospital Comarcal Santiago Apostol , Miranda de Ebro-Burgos , Spain. FAU - Vicente, Eduardo AU - Vicente E AD - d Urology Department , Parc Tauli University Hospital , Sabadell, Barcelona , Spain. FAU - Grill, Robert AU - Grill R AD - e Charles University , Prague , Czech Republic. FAU - Kachlirova, Zuzana AU - Kachlirova Z AD - e Charles University , Prague , Czech Republic. FAU - Stari, Anny AU - Stari A AD - f Astellas Pharma Europe Ltd , Chertsey , Surrey UK. FAU - Huang, Moses AU - Huang M AD - f Astellas Pharma Europe Ltd , Chertsey , Surrey UK. FAU - Choudhury, Nurul AU - Choudhury N AD - f Astellas Pharma Europe Ltd , Chertsey , Surrey UK. LA - eng SI - ClinicalTrials.gov/NCT02320773 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180110 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Acetanilides) RN - 0 (Thiazoles) RN - MVR3JL3B2V (mirabegron) SB - IM MH - Acetanilides/*therapeutic use MH - Aged MH - Female MH - Humans MH - Male MH - Middle Aged MH - Patient Satisfaction/*statistics & numerical data MH - Prospective Studies MH - *Quality of Life MH - Surveys and Questionnaires MH - Thiazoles/*therapeutic use MH - *Urinary Bladder, Overactive/drug therapy/epidemiology/psychology OTO - NOTNLM OT - Mirabegron OT - overactive bladder OT - persistence EDAT- 2017/12/20 06:00 MHDA- 2019/09/17 06:00 CRDT- 2017/12/20 06:00 PHST- 2017/12/20 06:00 [pubmed] PHST- 2019/09/17 06:00 [medline] PHST- 2017/12/20 06:00 [entrez] AID - 10.1080/03007995.2017.1419170 [doi] PST - ppublish SO - Curr Med Res Opin. 2018 May;34(5):785-793. doi: 10.1080/03007995.2017.1419170. Epub 2018 Jan 10.