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Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT – a double-blind, placebo-controlled trial

Authors


  • Disclosures Drs Vardy, Mitcheson, Samuels, and Wegenke were study investigators. Dr Vardy is a consultant for Astellas Pharma US, Inc. and a speaker for Wyeth and BARD Urologic. Dr Mitcheson is a study investigator for Pfizer, Novartis, Eli Lilly, Watson, and Antares; he is a speaker for GlaxoSmithKline. Dr Forero-Schwanhaeuser is an employee of GlaxoSmithKline, and Drs Marshall and He are employees of Astellas Pharma US Inc.

  • Clinical trial registration number: NCT00573508.

  • Registry name: Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life (VIBRANT).

Michael D. Vardy, MD, Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science, Mount Sinai School of Medicine, 2500 Johnson Ave, 8P, Riverdale, NY 10463, USA
Tel.: + 1 917 504 0415
Fax: + 1 866 808 4017
Email: dr.vardy@gmail.com

Summary

Aim:  The aim of this study was to evaluate the efficacy of solifenacin on symptom bother using the Overactive Bladder Questionnaire (OAB-q).

Methods:  In VIBRANT, a double-blind, US-based trial, patients with OAB for ≥ 3 months received flexibly dosed solifenacin or placebo for 12 weeks. At baseline and 4-week intervals, patients completed the OAB-q [symptom bother and health-related quality of life (HRQL) scales] and 3-day bladder diaries; other patient-reported outcome measures were also assessed at baseline and week 12. The primary efficacy end-point was the change from baseline to end of treatment (EOT) on the OAB-q Symptom Bother scale. Adverse events (AEs) were monitored.

Results:  At EOT, solifenacin (n = 377) vs. placebo (n = 374) significantly improved mean symptom bother (−29.9 vs. −20.4, p < 0.0001), HRQL total (25.3 vs. 16.7, p < 0.0001) and all HRQL domain scores (Ps < 0.0001). Solifenacin vs. placebo significantly improved daily episodes of urgency, incontinence and frequency but not nocturia. Significant separation from placebo was evident as early as week 4. Overall, significantly more solifenacin vs. placebo patients reported treatment benefit (84% vs. 63%), satisfaction (80% vs. 59%) and willingness to continue (79% vs. 60%; Ps< 0.0001). Treatment-related AEs in solifenacin vs. placebo patients were dry mouth (13% vs. 2%), constipation (8% vs. 2%) and dry eye (2% vs. 0.3%).

Conclusions:  As early as week 4 and through EOT, flexibly dosed solifenacin significantly improved OAB symptom bother and HRQL as well as the symptoms of urgency, frequency and incontinence compared with placebo. Significantly more solifenacin patients reported treatment benefit and satisfaction at week 12 compared with placebo.

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