Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study)
| Autor: | Matthias Stoelzel, Arwin Ridder, Kyu-Sung Lee, Salvador Arlandis, Dudley Robinson, Sender Herschorn, Rob van Maanen, David Mitcheson, Asha Paireddy, Christopher R. Chapple, Paul Abrams |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Internationality Time Factors Urinary urgency Maximum Tolerated Dose Urology Urinary system 030232 urology & nephrology Urinary incontinence urologic and male genital diseases Risk Assessment Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Double-Blind Method medicine Humans Nocturia Single-Blind Method Aged Solifenacin Urinary bladder Dose-Response Relationship Drug Urinary Bladder Overactive business.industry Solifenacin Succinate Middle Aged medicine.disease female genital diseases and pregnancy complications Thiazoles Treatment Outcome Urinary Incontinence medicine.anatomical_structure Overactive bladder 030220 oncology & carcinogenesis Multivariate Analysis Acetanilides Drug Therapy Combination Female medicine.symptom Mirabegron business Follow-Up Studies medicine.drug |
| Zdroj: | BJU INTERNATIONAL r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 1464-4096 |
| Popis: | Objective To evaluate the potential of solifenacin 5 mg combined with mirabegron 25 or 50 mg to deliver superior efficacy compared with monotherapy, with acceptable tolerability, in the general overactive bladder (OAB) population with urinary incontinence (UI). Patients and Methods After a 4-week placebo run-in, patients aged 18 years with wet OAB (urgency, urinary frequency and UI) for 3 months who recorded on average 8 micturitions/24 h, 1 urgency episode/24 h, and 3 UI episodes over the 7-day micturition diary, were eligible for randomisation to double-blind treatment [2:2:1:1:1:1 ratio, solifenacin 5 mg + mirabegron 25 mg (combined S5 + M25 group); solifenacin 5 mg + mirabegron 50 mg (combined S5 + M50 group); solifenacin 5 mg; mirabegron 25 mg; mirabegron 50 mg; or placebo for 12 weeks], and 2-weeks' single-blind, placebo run-out. Co-primary efficacy variables were change from baseline to end of treatment (EoT) in the mean number of UI episodes/24 h and micturitions/24 h, assessed using a 7-day electronic micturition diary. Secondary efficacy variables included change from baseline to EoT in the mean volume voided/micturition, change from baseline at weeks 4, 8, 12 and EoT in mean number of UI episodes/24 h, micturitions/24 h, urgency episodes/24 h, urgency UI (UUI) episodes/24 h and nocturia episodes/24 h; the percentage of patients (responders) achieving zero UI episodes/24 h at EoT in the last 7 days prior to each visit, micturition frequency normalisation ( |
| Databáze: | OpenAIRE |
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