PMID- 37143383
OWN - NLM
STAT- MEDLINE
DCOM- 20230704
LR  - 20230704
IS  - 1757-5672 (Electronic)
IS  - 1757-5664 (Linking)
VI  - 15
IP  - 4
DP  - 2023 Jul
TI  - Mirabegron versus vibegron in previously untreated female patients with 
      overactive bladder: A randomized, single-clinic, open-label trial.
PG  - 129-138
LID - 10.1111/luts.12480 [doi]
AB  - OBJECTIVES: This study aimed to assess the efficacy and safety of mirabegron 
      compared with vibegron (both 50 mg once daily) in Japanese female patients with 
      symptoms of overactive bladder (OAB). METHODS: This prospective, 12-week, 
      two-arm, parallel-group, open-label randomized trial (UMIN000038288) was 
      conducted at a single clinic from December 2019 to September 2022. The primary 
      efficacy outcome measure was the change in mean total overactive bladder symptom 
      scores (OABSSs) from baseline to end of treatment (EOT) (Week 12). The secondary 
      efficacy outcome measures were changes in mean International Prostate Symptom 
      Score from baseline to EOT, the ratio of patients who achieved a minimal 
      clinically important change (MCIC) of total OABSS, and individual domains of the 
      King's Health Questionnaire. Safety assessments, such as adverse events (AEs), 
      postvoid residual volume, and patient-reported incidences, were recorded at every 
      visit. RESULTS: There was no statistically significant adjusted mean difference 
      between mirabegron and vibegron in terms of the primary outcome of the mean 
      change from baseline to EOT in the total OABSS. The difference in the percentage 
      of patients in the mirabegron and vibegron groups achieving an MCIC on the total 
      OABSS was not statistically significant but appeared to be clinically important. 
      The incidence of treatment-related AEs was significantly higher for the vibegron 
      group (38.5%) than the mirabegron group (19.1%) (p = .047). CONCLUSIONS: These 
      results showed that both drugs were effective in female OAB patients, with no 
      significant differences in terms of efficacy. However, the safety of vibegron 
      requires further investigation.
CI  - (c) 2023 The Authors. LUTS: Lower Urinary Tract Symptoms published by John Wiley & 
      Sons Australia, Ltd.
FAU - Sato, Hirotaka
AU  - Sato H
AUID- ORCID: 0000-0002-4793-5845
AD  - Department of Urology, Hokusuikai Kinen Hospital, Ibaraki, Japan.
FAU - Otsuka, Shota
AU  - Otsuka S
AUID- ORCID: 0000-0002-2232-8387
AD  - Department of Urology, Hokusuikai Kinen Hospital, Ibaraki, Japan.
FAU - Tsukada, Sachiyuki
AU  - Tsukada S
AD  - Department of Orthopedic Surgery, Hokusuikai Kinen Hospital, Ibaraki, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230504
PL  - Australia
TA  - Low Urin Tract Symptoms
JT  - Lower urinary tract symptoms
JID - 101506777
RN  - MVR3JL3B2V (mirabegron)
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 (Urological Agents)
RN  - 0 (Acetanilides)
SB  - IM
MH  - Male
MH  - Humans
MH  - Female
MH  - *Urinary Bladder, Overactive/diagnosis
MH  - Prospective Studies
MH  - *Urological Agents/adverse effects
MH  - Treatment Outcome
MH  - Acetanilides/adverse effects
MH  - Double-Blind Method
OTO - NOTNLM
OT  - female
OT  - mirabegron
OT  - overactive bladder
OT  - overactive bladder symptom score
OT  - quality of life
OT  - vibegron
EDAT- 2023/05/05 06:42
MHDA- 2023/07/04 06:42
CRDT- 2023/05/05 03:42
PHST- 2023/03/10 00:00 [revised]
PHST- 2023/01/06 00:00 [received]
PHST- 2023/04/19 00:00 [accepted]
PHST- 2023/07/04 06:42 [medline]
PHST- 2023/05/05 06:42 [pubmed]
PHST- 2023/05/05 03:42 [entrez]
AID - 10.1111/luts.12480 [doi]
PST - ppublish
SO  - Low Urin Tract Symptoms. 2023 Jul;15(4):129-138. doi: 10.1111/luts.12480. Epub 
      2023 May 4.