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Therapeutic Alternative for Patients with Residual Urgency and Severe Symptom Bother while Taking Tolterodine ER to Treat Overactive Bladder: Results from the VERSUS Trial
Pamela Coleman1, Marc Gittelman*2, Paul Siami*3, Sergio Forero-Schwanhaeuser*4
1Providence Hospital, Washington, DC;2South Florida Medical Research, Aventura, FL;3Welborn Clinic, Evansville, IN;4GlaxoSmithKline, King of Prussia, PA
Introduction: Overactive bladder (OAB) symptoms are a subset of lower urinary tract symptoms generally described as irritative and often characterized by patient report of symptom bother. Clinical management of OAB may vary according to disease severity or treatment history. In the VESIcare Efficacy and Research Study US (VERSUS), patients experiencing residual urgency while taking tolterodine ER were transitioned to solifenacin to determine any changes.
Methods: VERSUS was an open-label, 12-week study of solifenacin in patients with OAB (≥3 months) who took tolterodine ER 4 mg for ≥4 weeks but still experienced urgency ≥3 times/day on average. After a 14-day washout, patients began solifenacin 5 mg/day, with a flexible-dose option of 10 mg/day at weeks 4 and 8. Episodes of urgency (primary endpoint) and other OAB symptoms were recorded in bladder diaries. Patient-reported outcomes were assessed using the Patient Perception of Bladder Condition (PPBC) scale and the Overactive Bladder Questionnaire (OAB-q). This analysis includes 165 patients with severe OAB (defined as PPBC score ≥5 pre-washout).
Results: See Table.
Conclusions: In patients with severe symptom bother who experienced insufficient relief with tolterodine ER, solifenacin at either 5-mg or 10-mg doses reduced OAB symptoms and improved symptom bother and health-related quality of life.
Table. Outcomes for patients with severe sympton bother in VERSUS (PPBC = 5 or greater pre-washout) | Pre-washout Baseline (mean) | End of study (mean) | Mean change from baseline | 95% Confidence Interval | | Urgency episodes/day* | 6.8 | 3.2 | -3.6 | -4.3, -2.8 | | PPBC score* | 5.3 | 3.5 | -1.8 | -2.0, -1.5 | | OAB-q score: Symptom bother* | 66.7 | 33.6 | -33.2 | -37.3, -29.0 | | OAB-q score: Coping | 44.1 | 74.0 | 29.9 | 25.3, 34.6 | | OAB-q score: Concern | 41.0 | 73.2 | 32.2 | 28.0, 36.4 | | OAB-q score: Sleep | 40.8 | 68.8 | 28.0 | 23.8, 32.2 | | OAB-q score: Social interaction | 72.4 | 88.8 | 16.3 | 12.9, 19.7 | | OAB-q score: Health-related quality of life | 48.3 | 75.8 | 27.5 | 23.8, 31.2 | | *decrease from baseline indicates improvement | | | | |
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