Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial

Efficacy and safety of vibegron, a β -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. Men ≥ 45 years with OAB symptoms and BPH, treated wit...

Full description

Saved in:
Bibliographic Details
Published inThe Journal of urology p. 101097JU0000000000003999
Main Authors Staskin, David, Owens-Grillo, Janet, Thomas, Elizabeth, Rovner, Eric, Cline, Kevin, Mujais, Salim
Format Journal Article
LanguageEnglish
Published United States 06.05.2024
Subjects
Online AccessGet full text

Cover

Loading…
Abstract Efficacy and safety of vibegron, a β -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary endpoints were change from baseline (CFB) at week 12 in mean daily micturitions and urgency episodes. Secondary endpoints were CFB at week 12 in mean nightly nocturia and daily urge urinary incontinence (UUI) episodes, International Prostate Symptom Score (IPSS)‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [LSMD; 95% CI], -0.74 [-1.02, -0.46]; < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (LSMD, -0.22 [-0.36, -0.09]; = .002), UUI episodes (-0.80 [-1.33, -0.27]; = .003), IPSS‒storage scores (-0.9 [-1.2, -0.6]; < .0001), and volume voided (15.07 mL [9.13-21.02]; < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%, respectively), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). In this trial, vibegron met all primary and secondary endpoints and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.
AbstractList Efficacy and safety of vibegron, a β -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary endpoints were change from baseline (CFB) at week 12 in mean daily micturitions and urgency episodes. Secondary endpoints were CFB at week 12 in mean nightly nocturia and daily urge urinary incontinence (UUI) episodes, International Prostate Symptom Score (IPSS)‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [LSMD; 95% CI], -0.74 [-1.02, -0.46]; < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (LSMD, -0.22 [-0.36, -0.09]; = .002), UUI episodes (-0.80 [-1.33, -0.27]; = .003), IPSS‒storage scores (-0.9 [-1.2, -0.6]; < .0001), and volume voided (15.07 mL [9.13-21.02]; < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%, respectively), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). In this trial, vibegron met all primary and secondary endpoints and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.
Author Mujais, Salim
Staskin, David
Cline, Kevin
Rovner, Eric
Owens-Grillo, Janet
Thomas, Elizabeth
Author_xml – sequence: 1
  givenname: David
  surname: Staskin
  fullname: Staskin, David
  organization: Tufts University School of Medicine, Boston, Massachusetts
– sequence: 2
  givenname: Janet
  surname: Owens-Grillo
  fullname: Owens-Grillo, Janet
  organization: Sumitomo Pharma America, Inc., Marlborough, Massachusetts
– sequence: 3
  givenname: Elizabeth
  surname: Thomas
  fullname: Thomas, Elizabeth
  organization: Sumitomo Pharma America, Inc., Marlborough, Massachusetts
– sequence: 4
  givenname: Eric
  surname: Rovner
  fullname: Rovner, Eric
  organization: Medical University of South Carolina, Charleston, South Carolina
– sequence: 5
  givenname: Kevin
  surname: Cline
  fullname: Cline, Kevin
  organization: Louisiana State University Health, Shreveport, Louisiana
– sequence: 6
  givenname: Salim
  surname: Mujais
  fullname: Mujais, Salim
  organization: Sumitomo Pharma America, Inc., Marlborough, Massachusetts
BackLink https://www.ncbi.nlm.nih.gov/pubmed/38708869$$D View this record in MEDLINE/PubMed
BookMark eNqFkM1OwlAUhG-MRkB9BXNegKS0Yos7S4psDE1Bt-TQnpZr7k9z7oWkvqYvZGt07WpmMflmMhNxaayhCzGezcN4GsWLcCQmzn0EwexhHofXYhQlcZAkj4ux-MrqWpZYdoCmgi3W5DuwNbzLAzVsDdSWISd20nkyHradbr3VbshszsRYenkmSBVWFTFIA69kICVpGsiPyBpLq2zTVyjVwY4JPVU_0JSMbAzkbJ1HL0tYdy1xq9BJfIKC3El5Byu2GvyRBpgjiKDod1otP3vK0hrPVqnBbt6K55esL5CobsVVjcrR3a_eiPtVtluup-3poKnatyw1crf_eyH6N_ANTe5tcw
ContentType Journal Article
DBID NPM
DatabaseName PubMed
DatabaseTitle PubMed
DatabaseTitleList PubMed
Database_xml – sequence: 1
  dbid: NPM
  name: PubMed
  url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
DeliveryMethod fulltext_linktorsrc
Discipline Medicine
EISSN 1527-3792
ExternalDocumentID 38708869
Genre Journal Article
GroupedDBID ---
--K
.XZ
0R~
123
1B1
354
4.4
457
4Q1
4Q2
4Q3
53G
5RE
AAAAV
AAEDT
AAGIX
AAHPQ
AAIQE
AAJCS
AAMOA
AAQKA
AASCR
AASXQ
ABASU
ABCQX
ABDIG
ABJNI
ABLJU
ABOCM
ABPPZ
ABVCZ
ACGFS
ACILI
ACLDA
ACOAL
ACXJB
ADGGA
ADHPY
AEBDS
AENEX
AFDTB
AFEXH
AFUWQ
AHOMT
AHQNM
AINUH
AJIOK
AJNWD
AJZMW
AKULP
ALMA_UNASSIGNED_HOLDINGS
ALMTX
AMJPA
AMKUR
AMNEI
ASGHL
BCGUY
BELOY
BYPQX
C45
C5W
CS3
DIWNM
DU5
EBS
EEVPB
EJD
ERAAH
EX3
F5P
FCALG
FDB
GBLVA
GNXGY
GQDEL
HLJTE
IH2
IHE
IKREB
IKYAY
IPNFZ
KMI
L7B
MJL
MO0
NPM
O9-
OAG
OAH
OB3
OBH
ODMTH
OGROG
OL1
OVD
OWW
OWY
P2P
RIG
RLZ
RPZ
SEL
SES
SJN
SSZ
TEORI
TSPGW
UNMZH
UV1
VVN
WOW
XH2
YFH
YOC
ZFV
ZY1
ID FETCH-pubmed_primary_387088693
IngestDate Thu Oct 24 10:00:47 EDT 2024
IsPeerReviewed true
IsScholarly true
Keywords beta-3 adrenergic agonist
anticholinergics
overactive bladder
benign prostatic hyperplasia
Language English
LinkModel OpenURL
MergedId FETCHMERGED-pubmed_primary_387088693
PMID 38708869
ParticipantIDs pubmed_primary_38708869
PublicationCentury 2000
PublicationDate 2024-May-06
PublicationDateYYYYMMDD 2024-05-06
PublicationDate_xml – month: 05
  year: 2024
  text: 2024-May-06
  day: 06
PublicationDecade 2020
PublicationPlace United States
PublicationPlace_xml – name: United States
PublicationTitle The Journal of urology
PublicationTitleAlternate J Urol
PublicationYear 2024
References 38716839 - J Urol. 2024 May 8;:101097JU0000000000004021
References_xml
SSID ssj0014572
Score 4.617863
Snippet Efficacy and safety of vibegron, a β -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic...
SourceID pubmed
SourceType Index Database
StartPage 101097JU0000000000003999
Title Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/38708869
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnZ3NattAEMcXx4XSS0jatE3ThDn0JlRkfVku5BCXNCY0cUjtkFvQSqsisGUjSy3OU-Vd8kKZ2V1ZqttAGh-EkMRi7_xYz2r-M8PYJyuKO17StUze7eEGxe24JvcTYcY2j3yfAlsJ5TufnfuDsXt67V23WncN1VJZ8M_R7T_zSp5jVbyGdqUs2f-w7GpQvIDnaF88ooXx-CQbH1P9B-rXLvWXYSKUvOIq5eJnriWEJHEnU2aF8WM5nRezqRRvDPHHhnKtM_oTWn1Ilk4aV6Mv6O3BRV3Smsw4WRojci_RPaVB-yKjfp4XlDIiS74OcDubz2VKppLYLcpJsUC3WCev4HALYTjGJX7T2TS9pffKSiQ_odPh-JIiWyOas6a7XCeuSZe5zP8IAqCjvNDdxBrS_PJw-Bv35uZJnlZxpTCr07yVImpd0aaDTr-q9J88jZrvQ2xXqg91NW29htu0bqoWe3pd7lAEsHs6thofdM16zT8RnJ75VJLi4CIWBKqFzFo17urWBttwOl6bvTjpf786WsWtXK9L_ZGqp9b2KtJnGW2xTT1zcKTI2WYtkb1mL8-0nOINu68AAjQLKIBglkAFEKCtoQYIKoDomRog0ABBmgECBBIg-Asg0ADJQRVAsAIIGgB9AY0PED6A-IDEBxyo8YEaH9D4gMRnhx18Ox59HZhqSm7mqpzKTTVZzlvWzmaZeM_ADbgdeYEV-3HsoovfC0KXJzz0Ii-2hG_vsnePDPLh0Tt77FWNy0fWLvJS7KNDWfADbcUHtk2HAg
link.rule.ids 315,786,790
linkProvider Elsevier
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Efficacy+and+Safety+of+Vibegron+for+Persistent+Symptoms+of+Overactive+Bladder+in+Men+Being+Pharmacologically+Treated+for+Benign+Prostatic+Hyperplasia%3A+Results+From+the+Phase+3+Randomized+Controlled+COURAGE+Trial&rft.jtitle=The+Journal+of+urology&rft.au=Staskin%2C+David&rft.au=Owens-Grillo%2C+Janet&rft.au=Thomas%2C+Elizabeth&rft.au=Rovner%2C+Eric&rft.date=2024-05-06&rft.eissn=1527-3792&rft.spage=101097JU0000000000003999&rft_id=info%3Apmid%2F38708869&rft.externalDocID=38708869