Quality of life and treatment persistence evaluation in Spanish patients treated with mirabegron. Results of the BELIEVE study

The BELIEVE study is a European, non-interventional study which includes patients with overactive bladder who were prescribed mirabegron as part of routine clinical practice. Data from the Spanish subpopulation has been obtained for the present study, aiming to analyze health-related quality-of-life (HRQoL) and treatment persistence of these patients. Data from 11 Spanish hospitals of the BELIEVE study were analyzed. The primary endpoint was to evaluate change of HRQoL from baseline with overactive bladder questionnaire (OAB-q). Secondary endpoints included treatment persistence, HRQoL based on the EQ-5D-5L questionnaire and adverse events. Study follow-up was 12 months, with two visit windows at 2-4 months and 10-12 months. 153 Spanish patients were enrolled in the study. In the Full Analysis Set (FAS), 63.1% were women, and the mean age was 66 years. Symptom bother and HRQoL improved from baseline to 2-4 months and 10-12 months. EQ-5D-5L questionnaire also showed an improved patients' HRQoL. Treatment persistence was high, as 49% of patients remained with mirabegron at 10-12 months. Adverse events were consistent with previous safety profile results of mirabegron, and no unexpected safety issues were observed. Spanish patients treated with mirabegron in real clinical practice reported improvements in HRQoL, with a good tolerability and persistence to treatment.