Improvement of health-related quality of life in patients with overactive bladder syndrome: A subanalysis of the prospective, noninterventional study BELIEVE in the Greek population

Abstract

Objective: The BELIEVE study is a prospective, noninterventional study which was conducted in a real-world setting in Europe and assessed quality of life, treatment satisfaction, healthcare resource utilization, and persistence with treatment in patients with overactive bladder (OAB) syndrome prescribed mirabegron as part of routine clinical practice. We present the results of a subanalysis of the BELIEVE study in the Greek population. Materials and Methods: The primary endpoint was change from baseline in quality of life (QoL) based on the OAB-questionnaire (OAB-q), consisting of the Symptom Bother Scale and health-related QoL (HRQoL). Change from baseline in QoL based on the EQ-5D-5 L health survey, treatment patterns and persistence with treatment, as well as adverse events during the study were also assessed. The duration of the observation period was 12 months. Results: A total of 97 OAB patients from 10 sites in Greece participated in the substudy; 89 completed the OAB-q at baseline and at least at one follow-up visit (Full Analysis Set, mean age 62.7 ± 10.9 years, 86.5% female). At baseline, 73% of patients were “new,” 14.6% were “lapsed,” 9% switched treatment, and 3.4% were on combination treatment. The scores in the Symptom Bother Scale and HRQoL Scale improved significantly from baseline at 10–12 months (−32.4 ± 2.54 and 30.2 ± 2.49, respectively). The EQ-5D subscales confirmed that mirabegron led to an improvement in the HRQoL of patients. At 10–12 months, 72% of patients were continuing on mirabegron treatment for OAB, either as single treatment (60%) or as combination treatment (12%). Mirabegron was well-tolerated, as no serious drug-related adverse events (AEs) were observed, whereas only a small percentage (6.2%) of drug-related AEs resulted in treatment discontinuation. Conclusions: The Greek population subanalysis confirmed the European results of the BELIEVE study. Patients who received mirabegron in a real-world setting showed clinically meaningful improvements in HRQoL. Mirabegron demonstrated a high persistence rate (72% at 12 months), and good tolerability. The overall improvement in HRQoL, particularly in the population continuing to receive mirabegron at 10–12 months, and the low incidence of AEs may have contributed to the high persistence rate.