Real-world outcomes of vibegron in patients with overactive bladder: The phase 4 COMPOSUR study

Background Overactive bladder (OAB) symptoms impair patient health-related quality of life (HRQL). Vibegron is a β 3 -adrenergic receptor agonist with reported efficacy and safety in phase 3 clinical trials for patients with OAB, but limited evidence is available regarding vibegron treatment outcomes in a real-world setting. Objective To evaluate patient-reported outcomes in treatment satisfaction, persistence, and safety of vibegron in a real-world US setting in patients with OAB who were previously treated with anticholinergic medications or mirabegron with or without anticholinergics. Design and Methods COMPOSUR was a phase 4, 12-month, observational study of vibegron in patients with OAB. Patients were prescribed once-daily vibegron 75 mg, not supplied free of charge; they completed the OAB Satisfaction With Treatment Questionnaire (OAB-SAT-q) and the OAB Questionnaire short form (OAB-q) monthly. Other assessments included treatment persistence, adverse events (AEs), and reasons for discontinuation. Results Overall, 403 patients were enrolled; 169 discontinued the study, most commonly owing to lack of efficacy (n=42, 24.9%) and consent withdrawal (n=40, 23.7%). Mean (SD) patient age was 56.1 (12.5) years; 28.3% were male. At month 12, mean (SD) OAB-SAT-q domain scores were: satisfaction, 65.6 (24.7); convenience, 82.1 (21.3); side effects, 88.7 (21.3); and endorsement, 71.4 (26.8). Most patients (69.0%) were satisfied with vibegron and reported positive responses to individual OAB-SAT-q questions; 77.9% preferred vibegron over their prior treatment. Persistence with vibegron treatment was 59.8% (95% CI, 54.7%-64.6%) at month 12. Mean (SD) change from baseline in OAB-q symptom severity and HRQL scores was −26.9 (24.3) and 24.5 (22.7), respectively. Overall, 36.0% of patients experienced ≥1 treatment-emergent AE, most commonly urinary tract infection (4.0%), headache (2.7%), and dizziness (2.2%). Conclusion Treatment satisfaction, persistence, and safety of vibegron were consistent with interim results from the COMPOSUR study and support real-world application and tolerance of vibegron in patients with OAB.