Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study

Abstract

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 naïve, 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.

Keywords:

• Mirabegron
• persistence
• overactive bladder

Note

Transparency

Declaration of funding

This paper was funded by Astellas Pharma Europe B.V.

Disclosures/conflict of interest

RF is a speaker for Astellas, Pfizer, and Bard. SF is a speaker and consultant for Astellas. JRA is an investigator for Astellas and Ipsen. EV is a speaker for Astellas, Gebro Pharma, Rovi, Pierre Fabre and Coloplast. RG and ZK are consultants for Astellas. NC, AS, and MH are employees of Astellas Pharma Europe Ltd. This study is registered at ClinicalTrials.gov: NCT02320773. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

The authors would like to thank the BELIEVE study investigators, Sally Bowditch at Astellas, and all patients and their parents/legal representatives who took part in the study. This study was funded by Astellas Pharma Europe B.V. Medical writing support was provided by Sue Cooper of Envision Scientific Solutions and funded by Astellas Pharma Global Development.

Notes

1 Methods, definitions and units conform to the standards jointly recommended by the International Urogynecological Association and the International Continence Society³⁵, except where specifically noted.