PMID- 33469832
OWN - NLM
STAT- MEDLINE
DCOM- 20211021
LR  - 20211021
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Print)
IS  - 1170-229X (Linking)
VI  - 38
IP  - 2
DP  - 2021 Feb
TI  - Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in 
      Patients Aged >/=65 and >/=75 Years: Subpopulation Analysis from the EMPOWUR 
      Randomized, International, Phase III Study.
PG  - 137-146
LID - 10.1007/s40266-020-00829-z [doi]
AB  - BACKGROUND: Overactive bladder (OAB) is common among older adults. The efficacy 
      and safety of vibegron for the treatment of OAB were demonstrated in the 
      international, phase III EMPOWUR trial. This subpopulation analysis from EMPOWUR 
      assessed the efficacy and safety of vibegron in patients aged >/= 65 and >/= 75 
      years. METHODS: In EMPOWUR, patients with OAB were randomly assigned 5:5:4 to 
      receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, 
      respectively, once daily for 12 weeks. Coprimary efficacy endpoints were change 
      from baseline at week 12 in average daily number of micturitions and urge urinary 
      incontinence (UUI) episodes; a key secondary efficacy endpoint was change from 
      baseline at week 12 in average daily number of urgency episodes. Safety was 
      assessed through adverse events (AEs). Efficacy analyses compared vibegron with 
      placebo; no efficacy comparisons were made between vibegron and tolterodine. 
      RESULTS: Of the 1463 patients with evaluable efficacy data, 628 patients were 
      aged >/= 65 years, and 179 were aged >/= 75 years. After 12 weeks, patients treated 
      with once-daily vibegron 75 mg in both age subgroups showed significant 
      improvements from baseline versus placebo in all three symptoms of OAB: daily 
      micturitions (>/= 65 years, P < 0.0001; >/=75 years, P < 0.05), UUI episodes (>/= 65 
      years, P < 0.001; >/= 75 years, P < 0.0001), and urgency episodes (>/= 65 years, P < 
      0.01; >/= 75 years, P < 0.01). Significant reductions from baseline versus placebo 
      in daily micturitions, UUI episodes, and urgency episodes were observed beginning 
      at week 2 for patients aged >/= 65 years treated with vibegron. In patients aged >/= 
      65 years, 50.0% of those receiving vibegron versus 29.8% receiving placebo 
      experienced a >/= 75% reduction in UUI episodes at week 12 (P < 0.0001). Rates of 
      cardiovascular-associated AEs were low for patients receiving vibegron (<2% of 
      patients in either age subgroup) and similar to rates in patients receiving 
      placebo. In patients aged >/= 65 years, hypertension was reported by 1.2%, 3.1%, 
      and 2.9% of patients receiving vibegron, placebo, and tolterodine, respectively; 
      in patients aged >/= 75 years, hypertension was reported by 1.3%, 3.3%, and 2.1%, 
      respectively. CONCLUSIONS: In this subpopulation analysis of patients with OAB 
      aged >/= 65 and >/= 75 years from the EMPOWUR study, once-daily vibegron 75 mg showed 
      rapid onset and robust efficacy versus placebo and was generally safe and 
      well tolerated, consistent with results from the overall population. TRIAL 
      REGISTRATION: ClinicalTrials.gov identifier NCT03492281; registered April 10, 
      2018.
FAU - Varano, Susann
AU  - Varano S
AD  - Geriatric Medicine, Clinical Research Consulting, 2080 Bridgeport Avenue, Suite 
      D, Milford, CT, 06460, USA. varanos2@yahoo.com.
FAU - Staskin, David
AU  - Staskin D
AD  - Department of Surgery, Division of Urology, Tufts University School of Medicine, 
      Boston, MA, USA.
FAU - Frankel, Jeffrey
AU  - Frankel J
AD  - Urology, Seattle Urology Research Center, Seattle, WA, USA.
FAU - Shortino, Denise
AU  - Shortino D
AD  - Biostatistics, Urovant Sciences, Irvine, CA, USA.
FAU - Jankowich, Rachael
AU  - Jankowich R
AD  - Clinical Development, Urovant Sciences, Irvine, CA, USA.
FAU - Mudd, Paul N Jr
AU  - Mudd PN Jr
AD  - Clinical Development, Urovant Sciences, Irvine, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03492281
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210120
PL  - New Zealand
TA  - Drugs Aging
JT  - Drugs & aging
JID - 9102074
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)
RN  - 0 (Pyrrolidines)
SB  - IM
MH  - Aged
MH  - Double-Blind Method
MH  - Humans
MH  - Pyrimidinones
MH  - Pyrrolidines
MH  - Treatment Outcome
MH  - *Urinary Bladder, Overactive/drug therapy
PMC - PMC7882560
COIS- S. Varano is principal investigator for Clinical Research Consulting and adjunct 
      professor at Sacred Heart University and University of Bridgeport. D. Staskin is 
      an investigator and consultant for Urovant Sciences; a consultant, investigator, 
      and speaker for Astellas Pharma; and a consultant for New Uro B.V. J. Frankel is 
      an investigator for Urovant Sciences, an investigator and speaker for Astellas 
      Pharma and Pfizer Inc., and a speaker for Tolmar Inc. D. Shortino, R. Jankowich, 
      and P.N. Mudd Jr are employees of Urovant Sciences and may be shareholders.
EDAT- 2021/01/21 06:00
MHDA- 2023/02/25 06:00
PMCR- 2021/01/20
CRDT- 2021/01/20 05:58
PHST- 2020/11/28 00:00 [accepted]
PHST- 2021/01/21 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2021/01/20 05:58 [entrez]
PHST- 2021/01/20 00:00 [pmc-release]
AID - 10.1007/s40266-020-00829-z [pii]
AID - 829 [pii]
AID - 10.1007/s40266-020-00829-z [doi]
PST - ppublish
SO  - Drugs Aging. 2021 Feb;38(2):137-146. doi: 10.1007/s40266-020-00829-z. Epub 2021 
      Jan 20.