PMID- 36384907
OWN - NLM
STAT- MEDLINE
DCOM- 20221226
LR  - 20230309
IS  - 2771-1897 (Electronic)
IS  - 2771-1897 (Linking)
VI  - 29
IP  - 1
DP  - 2023 Jan 1
TI  - Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: 
      A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial.
PG  - 48-57
LID - 10.1097/SPV.0000000000001258 [doi]
AB  - IMPORTANCE: The international phase 3 EMPOWUR trial demonstrated efficacy and 
      safety of vibegron, a newer beta 3 -adrenergic receptor agonist, in adults with 
      overactive bladder (OAB). Women are disproportionately affected by OAB, 
      especially those with bothersome symptoms, such as urge urinary incontinence 
      (UUI). OBJECTIVE: This subgroup analysis from EMPOWUR assessed efficacy and 
      safety of vibegron in women. STUDY DESIGN: In EMPOWUR, patients with OAB were 
      randomized 5:5:4 to 12 weeks of treatment with once-daily vibegron 75 mg, 
      placebo, or tolterodine 4-mg extended release. Efficacy end points included 
      change from baseline at week 12 in mean daily number of micturitions, UUI 
      episodes, and urgency episodes. Safety was assessed through adverse events (AEs). 
      RESULTS: Of the patients included in the analysis, 1286 (84.9%) were women 
      (vibegron, n = 463; placebo, n = 459; tolterodine, n = 364). At week 12, women 
      receiving vibegron showed significant reductions (95% confidence intervals of 
      least squares mean differences does not include 0) from baseline versus placebo 
      in mean daily micturitions, UUI episodes, and urgency episodes, with least 
      squares mean differences (95% confidence intervals) of -0.5 (-0.8 to -0.2), -0.7 
      (-1.0 to -0.4), and -0.8 (-1.3 to -0.4), respectively. Treatment-emergent AE 
      incidence was similar with vibegron (39%) and placebo (35%); the most common AE 
      with incidence higher with vibegron (4.3%) than placebo (2.6%) was headache. 
      CONCLUSIONS: In this subgroup analysis, women receiving vibegron showed 
      significant reductions in key efficacy end points versus placebo and favorable 
      safety profile, consistent with the overall results from EMPOWUR, suggesting that 
      vibegron is efficacious and safe for the treatment of OAB in this patient 
      population.
CI  - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Newman, Diane K
AU  - Newman DK
AD  - From the Perelman School of Medicine, University of Pennsylvania, Philadelphia, 
      PA.
FAU - Thomas, Elizabeth
AU  - Thomas E
AD  - Urovant Sciences, Irvine, CA.
FAU - Greene, Heather
AU  - Greene H
AD  - Urovant Sciences, Irvine, CA.
FAU - Haag-Molkenteller, Cornelia
AU  - Haag-Molkenteller C
AD  - Urovant Sciences, Irvine, CA.
FAU - Varano, Susann
AU  - Varano S
AD  - Clinical Research Consulting, Milford, CT, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03492281
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20221021
PL  - United States
TA  - Urogynecology (Phila)
JT  - Urogynecology (Philadelphia, Pa.)
JID - 9918452588006676
RN  - 5T619TQR3R (Tolterodine Tartrate)
RN  - 0 
      (N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide)
RN  - 0 (Pyrimidinones)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Female
MH  - Male
MH  - *Urinary Bladder, Overactive/drug therapy
MH  - Tolterodine Tartrate/adverse effects
MH  - Treatment Outcome
MH  - Pyrimidinones
MH  - Urinary Incontinence, Urge/chemically induced
EDAT- 2022/11/18 06:00
MHDA- 2022/12/27 06:00
CRDT- 2022/11/17 10:05
PHST- 2022/11/18 06:00 [pubmed]
PHST- 2022/12/27 06:00 [medline]
PHST- 2022/11/17 10:05 [entrez]
AID - 02273501-202301000-00006 [pii]
AID - 10.1097/SPV.0000000000001258 [doi]
PST - ppublish
SO  - Urogynecology (Phila). 2023 Jan 1;29(1):48-57. doi: 10.1097/SPV.0000000000001258. 
      Epub 2022 Oct 21.