6-Month Interim Results of COMPOSUR: A Real-World Study of Vibegron for Overactive Bladder

Objectives: Vibegron (GEMTESA^®), a β₃-adrenergic receptor agonist approved in the US for the treatment of overactive bladder (OAB), was efficacious, safe, and well tolerated in the 12-week EMPOWUR trial and its 40-week double-blind extension. To assess vibegron in a real-world setting, the COMPOSUR study evaluated patient treatment satisfaction, tolerability, and safety (NCT05067478). Here we present the results of a planned 6-month interim analysis of selected endpoints.

Methods: This ongoing, 12-month, prospective, observational, real-world study of vibegron is enrolling patients ≥18 years old with OAB with or without urge urinary incontinence (UUI) who were starting a new course of vibegron and who had previous exposure to anticholinergics (Cohort A) or mirabegron with or without anticholinergics (Cohort B). Enrollment inclusion and exclusion criteria follow the vibegron US product label. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly; the primary endpoint is patient satisfaction assessed as a composite of OAB-SAT-q questions 1‒3 (6-point Likert scale; normalized score range: 0 [extremely dissatisfied] to 100 [extremely satisfied]). Safety is assessed by adverse events (AEs).

Results: As of the 6-month interim analysis, 252 patients have been enrolled (Cohort A, n=89; Cohort B, n=163); 42 patients have discontinued (Cohort A, n=12 [most common reasons: AE, n=4; withdrawal of consent, n=4; lack of efficacy, n=3]; Cohort B, n=30 [most common reasons: lack of efficacy, n=13; AE, n=8; withdrawal of consent, n=3]). Mean (SD) age was 54.5 (11.7) years, and 71% were female. As of month 6, 103 patients have completed the OAB-SAT-q. Mean (SD) OAB-SAT-q satisfaction scale score was 67.9 (21.6); 78% of patients were consistently satisfied with treatment (ie, selected satisfied or better on OAB-SAT-q questions 1, 2, and 3). Of the 103 patients who expressed a preference for an oral pharmacotherapy, 79 (77%) responded that they preferred vibegron compared with the treatment they received before entering the study (ie, selected slightly preferred or better on OAB-SAT-q question 8). Overall, 26% of patients experienced a treatment-emergent AE; 1 patient experienced a serious AE (atrial flutter; resolved, considered not related to study treatment). The most commonly reported AEs (≥2% of patients) were urinary tract infection (3.6%), headache (2.8%), and nausea (2.0%).

Conclusions: As of the 6-month interim analysis of the phase 4 COMPOSUR trial, most patients receiving vibegron were satisfied with treatment. Treatment with vibegron was generally safe and well tolerated. Data are preliminary, and the study remains ongoing.