Vibegron Persistence Near 60% at 1 Year in Real-World OAB Study

Among patients with overactive bladder (OAB) previously treated with an anticholinergic or mirabegron, 69.0% were consistently satisfied with vibegron (Gemtesa; Sumitomo Pharma America) after 12 months, and 59.8% remained on treatment in an exploratory analysis, according to final results of the phase 4 COMPOSUR study (NCT05067478).¹ The findings, published in Therapeutic Advances in Urology, extend 6-month interim results that also showed high satisfaction.²

Study Design and Patient Population

COMPOSUR was a prospective, observational study at 45 US sites, with enrollment from October 2021 to July 2023.¹ Of 403 patients, 142 had prior anticholinergic therapy (cohort A), and 261 had prior mirabegron with or without an anticholinergic (cohort B). All started once-daily vibegron 75 mg, a beta-3 adrenergic agonist. Patients obtained vibegron through usual insurance, not free from the sponsor.

The mean age was 56.1 years, 71.7% were women, and 14.1% were Black or African American. Patients completed the OAB Satisfaction With Treatment Questionnaire (OAB-SAT-q) and the OAB Questionnaire short form (OAB-q) monthly, and 234 (58.1%) completed the study. The primary objective was satisfaction, measured by the OAB-SAT-q satisfaction domain.

Satisfaction and Preference at 12 Months

The mean satisfaction domain score was 65.6 at month 12, above the threshold of 60 that indicates satisfaction. Among patients with at least 1 postbaseline assessment, 69.0% (95% CI, 64.1%-73.9%) were consistently satisfied, meaning they answered satisfied or higher on all 3 satisfaction questions. In a responder analysis that counted patients with no postbaseline assessment or early discontinuation as nonresponders, 48.6% (95% CI, 43.5%-53.7%) met the satisfaction threshold.

Among 326 patients who answered the preference question, 77.9% preferred vibegron to their previous treatment.

Persistence, an exploratory end point based on patient-reported treatment status, was 94.2% at 1 month, 84.9% at 3 months, 73.0% at 6 months (about 74% in the interim analysis), and 59.8% (95% CI, 54.7%-64.6%) at 12 months. Among 169 patients who discontinued vibegron, the primary reasons, as shares of that group, were lack of efficacy (24.9%), voluntary withdrawal (23.7%), cost (10.1%), and safety (7.7%).

The authors called these rates similar to those in the PERSPECTIVE registry (NCT02386072), which reported 12-month persistence of 68.6% for anticholinergics and 66.2% for mirabegron, but said methodological differences preclude direct comparison.^1,3 PERSPECTIVE enrolled treatment-naive and treatment-experienced patients in the US and Canada, and a Canadian patient-support program covered up to 100% of mirabegron costs for some participants.³ Its rates reflect only patients who answered follow-up requests.

Symptom Improvement and Safety Profile

At month 12, mean OAB-q symptom severity scores had fallen 26.9 points from baseline, and health-related quality of life scores had risen 24.5 points, with changes apparent by month 1.¹ At least 1 treatment-emergent adverse event (TEAE) occurred in 36.0% of patients, most commonly urinary tract infection (4.0%), headache (2.7%), and dizziness (2.2%). Serious TEAEs occurred in 2.0%, and 7.9% of all patients stopped vibegron because of a TEAE. Urinary retention occurred in 1.0% and hypertension in 0.7%. One patient died, and the death was considered unrelated to the drug.

"Vibegron use was generally safe and well tolerated over 12 months of real-world use,” the authors wrote.

Limitations and Disclosures

The study lacked randomization and a control group and made no comparisons with other OAB treatments. The authors noted that open-label treatment could have inflated satisfaction scores; patients with commercial insurance received a co-pay card; patients could use bladder training; and the results may not apply to treatment-naive patients. Dissatisfied patients may have been more likely to leave the study, and 41.9% discontinued treatment.

Missing data were handled with last observation carried forward, which the authors said may underestimate treatment impact; sensitivity analyses without imputation were also run. The analyses were descriptive, with no formal hypothesis testing or multiplicity adjustment.

Sumitomo Pharma America funded the study and the medical writing support. Three authors are current or former company employees, 4 others report consulting or advisory roles with Sumitomo, and another was a study investigator for the company. The authors called for future analyses to identify subgroups, such as men with benign prostatic hyperplasia, who may benefit most from vibegron.

References

1. Kennelly MJ, Rovner ES, Dmochowski RR, et al. Real-world outcomes of vibegron in patients with overactive bladder: the phase 4 COMPOSUR study. Ther Adv Urol. 2026;18:1-13. doi:10.1177/17562872261497025
2. Dmochowski RR, Rovner ES, Kennelly MJ, et al. Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study. BMC Urol. 2025;25:66. doi:10.1186/s12894-025-01742-6
3. Carlson KV, Rovner ES, Nair KV, et al. Persistence with mirabegron or antimuscarinic treatment for overactive bladder syndrome: findings from the PERSPECTIVE registry study. Low Urin Tract Symptoms. 2021;13(4):425-434. doi:10.1111/luts.12382