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Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY)
P. Abrams, C. Kelleher, D. Staskin, R. Kay, A. Martan, I. Mincik, D. Newgreen, A. Ridder, A. Paireddy, R. van Maanen,
Jazyk angličtina Země Německo
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, randomizované kontrolované studie
NLK
ProQuest Central
od 1997-02-01 do 2017-12-31
Medline Complete (EBSCOhost)
od 2000-02-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 1997-02-01 do 2017-12-31
- MeSH
- acetanilidy aplikace a dávkování MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hodnocení výsledků péče pacientem MeSH
- hyperaktivní močový měchýř farmakoterapie MeSH
- kombinovaná farmakoterapie MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- minimální klinicky významný rozdíl MeSH
- senioři MeSH
- solifenacin sukcinát aplikace a dávkování MeSH
- thiazoly aplikace a dávkování MeSH
- urologické látky aplikace a dávkování MeSH
- výsledek terapie MeSH
- zdravotní stav MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- randomizované kontrolované studie MeSH
PURPOSE: This large dose-ranging study explored the benefits of different combinations of mirabegron and solifenacin on health-related quality of life (HRQoL), based on patient-reported outcomes (PROs), and patients ('responders') achieving clinically meaningful improvements in efficacy and HRQoL. METHODS: SYMPHONY (NCT01340027) was a Phase II, placebo- and monotherapy-controlled, dose-ranging, 12-week trial. Adult patients with overactive bladder (OAB) for ≥3 months were randomized to 1 of 12 groups: 6 combination (solifenacin 2.5/5/10 mg + mirabegron 25/50 mg), 5 monotherapy (solifenacin 2.5/5/10 mg, or mirabegron 25/50 mg), or placebo. Change from baseline to end of treatment was assessed, versus placebo and solifenacin 5 mg in: PROs (OAB-q [Symptom Bother/total HRQoL] and Patient Perception of Bladder Condition score), and responders achieving minimally important differences (MIDs) in PROs and predetermined clinically meaningful improvements in efficacy (e.g. <8 micturitions/24 h). Changes in PROs and responders were analysed using an ANCOVA model and logistic regression, respectively. RESULTS: The Full Analysis Set included 1278 patients. Combination therapy of solifenacin 5/10 mg + mirabegron 25/50 mg significantly improved PROs versus solifenacin 5 mg and placebo, and significantly more responders achieved MIDs in PROs and efficacy. Micturition frequency normalization was approximately twofold greater with 10 + 25 mg (OR 2.06 [95 % CI 1.11, 3.84; p = 0.023]) and 5 + 50 mg (OR 1.91 [95 % CI 1.14, 3.21; p = 0.015]) versus solifenacin 5 mg. CONCLUSION: Combining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg.
Astellas Pharma BV Leiden The Netherlands
Bristol Urological Institute Southmead Hospital BS10 5NB Bristol UK
Faculty of Healthcare of the University of Prešov Prešov Slovakia
Citace poskytuje Crossref.org
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