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Statements

Subject Item
n2:RIV%2F00064190%3A_____%2F13%3A%230000711%21RIV14-MZ0-00064190
rdf:type
n10:Vysledek skos:Concept
dcterms:description
AimsTo evaluate the potential of mirabegron, a selective 3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms. MethodsA multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n=314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150mg twice-daily (BID), placebo or tolterodine 4mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, electrocardiogram parameters and post-void residual volume. ResultsMirabegron 100 and 150mg BID resulted in a statistically significant improvement versus placebo in mean change from baseline to end-of-treatment in the primary endpoint of micturition frequency (2.2micturitions/24hr vs. 1.2micturitions/24hr for both doses, adjusted P0.01 for both comparisons). Mirabegron had a statistically significant effect versus placebo for most secondary endpoints, including quality of life variables. Despite a small increase in pulse rate, mirabegron demonstrated good safety and tolerability. ConclusionsMirabegron was efficacious and well tolerated in patients with OAB symptoms and heralds the first of a new class of oral pharmacological therapy for OAB for more than 30 years AimsTo evaluate the potential of mirabegron, a selective 3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms. MethodsA multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n=314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150mg twice-daily (BID), placebo or tolterodine 4mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, electrocardiogram parameters and post-void residual volume. ResultsMirabegron 100 and 150mg BID resulted in a statistically significant improvement versus placebo in mean change from baseline to end-of-treatment in the primary endpoint of micturition frequency (2.2micturitions/24hr vs. 1.2micturitions/24hr for both doses, adjusted P0.01 for both comparisons). Mirabegron had a statistically significant effect versus placebo for most secondary endpoints, including quality of life variables. Despite a small increase in pulse rate, mirabegron demonstrated good safety and tolerability. ConclusionsMirabegron was efficacious and well tolerated in patients with OAB symptoms and heralds the first of a new class of oral pharmacological therapy for OAB for more than 30 years
dcterms:title
A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder
skos:prefLabel
A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder
skos:notation
RIV/00064190:_____/13:#0000711!RIV14-MZ0-00064190
n10:predkladatel
n17:ico%3A00064190
n3:aktivita
n14:N
n3:aktivity
N
n3:cisloPeriodika
8
n3:dodaniDat
n13:2014
n3:domaciTvurceVysledku
n9:3645754
n3:druhVysledku
n15:J
n3:duvernostUdaju
n4:S
n3:entitaPredkladatele
n18:predkladatel
n3:idSjednocenehoVysledku
58969
n3:idVysledku
RIV/00064190:_____/13:#0000711
n3:jazykVysledku
n6:eng
n3:klicovaSlova
3-adrenoceptor agonist; overactive bladder; phase 2 study
n3:klicoveSlovo
n12:phase%202%20study n12:3-adrenoceptor%20agonist n12:overactive%20bladder
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[8B0A306B8C8D]
n3:nazevZdroje
NEUROUROLOGY AND URODYNAMICS
n3:obor
n16:FP
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
9
n3:rokUplatneniVysledku
n13:2013
n3:svazekPeriodika
32
n3:tvurceVysledku
Vik, Viktor
n3:wos
000326027700012
s:issn
0733-2467
s:numberOfPages
6
n8:doi
10.1002/nau.22373