Solifenacin for Overactive Bladder: Patient-Reported Outcomes from a Large Placebo-Controlled Trial
| Autor: | Indrani Nandy, Scott Serels, Christine Laramée, Marc R. Toglia, Raafat Seifeldin, Mickey M. Karram, Masakazu Andoh, Sergio Forero-Schwanhaeuser |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Male
Solifenacin Succinate Quinuclidines medicine.medical_specialty Urinary urgency Urology Placebo-controlled study Muscarinic Antagonists urologic and male genital diseases law.invention Double-Blind Method Randomized controlled trial law Tetrahydroisoquinolines Internal medicine Multicenter trial medicine Clinical endpoint Humans Aged Solifenacin Urinary Bladder Overactive business.industry General Medicine Middle Aged medicine.disease female genital diseases and pregnancy complications Treatment Outcome Overactive bladder Female medicine.symptom business medicine.drug |
| Zdroj: | Postgraduate Medicine. 121:151-158 |
| ISSN: | 1941-9260 0032-5481 |
| Popis: | Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported.In this 12-week multicenter trial, 739 patients (agedor= 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo. Prespecified secondary PRO measures included the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). Appropriate statistical tests compared treatment-group differences in continuous and categorical data.In the full analysis set, patients who received solifenacin (n = 357) versus placebo (n = 350) showed significant improvements on the IUSS and UPS; treatment-group differences were 0.4 (P0.0001) and 0.2 (P = 0.0018), respectively. On the PPBC, significantly more patients taking solifenacin (66%) than placebo (48%) perceived fewer bladder-related problems (P0.0001) by week 12. On the OAB-q, solifenacin was superior to placebo for the Symptom Bother and total HRQL scales and for 3 of the 4 HRQL domains at study end (Por= 0.01). Overall, these findings were consistent with those reported previously for bladder-diary-documented urgency and other OAB symptoms.Flexibly dosed, once-daily solifenacin was associated with statistically significant and clinically meaningful improvements in urgency and other symptom-specific bother and HRQL compared with placebo. |
| Databáze: | OpenAIRE |
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