Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare® Open-Label Trial
Disclosure Dr Capo’ is a Consultant/Advisor for Astellas, Boehringer Mannheim Pharmaceuticals, Cephalon Inc. and GlaxoSmithKline; is a Speaker for Astellas, GlaxoSmithKline, Reliant Pharmaceuticals and Schering Plough Corporation; is an Investigator for Abbott, Akros, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Lilly, Mankind, Merck, Novartis, NovoNordisk, Pfizer Inc., Solvay, Takeda and TAP; and is a Lecturer for Pri Med. Dr Laramée is a Consultant/Advisor and Investigator for Astellas and GlaxoSmithKline. Dr Lucente has received research support in the past from Astellas and presently receives honoraria for lectures. Dr Fakhoury is an employee of Astellas Pharma US Inc. Dr Forero-Schwanhaeuser is an employee of GlaxoSmithKline.
Summary
Objective: The primary goal of overactive bladder (OAB) treatment is to reduce symptoms and improve health-related quality of life (HRQoL). Although trials open enrolment to everyone, most OAB studies feature Caucasians. Here we present Hispanic data.
Methods: VESIcare® Open-Label Trial was a 12-week, open-label, flexible-dosing study in patients with OAB symptoms for ≥ 3 months. All patients started on solifenacin 5 mg/day, with a dosing option of 5 or 10 mg/day at weeks 4 and 8. Three patient-reported outcome (PRO) measures assessed symptom improvement and treatment satisfaction: the Patient Perception of Bladder Condition (PPBC) scale, a Visual Analogue Scale (VAS), the Overactive Bladder Questionnaire (OAB-q).
Results: 94/2205 patients in the full population were Hispanic. Urgency was most frequently reported at baseline (93.6%), followed by frequency (91.5%), nocturia (84.0%) and urge incontinence (UI) (67.0%). Frequency was reported as the most bothersome symptom (MBS) by a higher proportion of Hispanics than the full population (40.4% vs. 28.1%). UI was reported as the MBS by a smaller proportion of Hispanics (18.1% vs. 27.3%). Patients reporting moderate-to-severe problems related to bladder condition at baseline reported improvement to ‘some minor problems’ at week 12. Over 72.0% of patients experienced PPBC score improvement. Both groups reported significant improvements in urgency, UI, frequency and nocturia on the VAS (all p < 0.001) and all OAB-q domains (all p < 0.001) at week 12.
Conclusion: Although numbers were small, Hispanics receiving solifenacin for OAB reported improvement from baseline in symptom bother and HRQoL, as assessed by three independent PRO measures.