Evidence map›Paper›PMID 34139038›Full record

Trial reportNeurourology and urodynamics2021

Cardiovascular safety of vibegron, a new β3-adrenoceptor agonist, in older patients with overactive bladder: Post-hoc analysis of a randomized, placebo-controlled, double-blind comparative phase 3 study.

Masaki Yoshida, Masayuki Takeda, Momokazu Gotoh, Osamu Yokoyama, Hidehiro Kakizaki, Satoru Takahashi, Naoya Masumori, Shinji Nagai, Kazuyoshi Minemura

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurourology and urodynamics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 1 country.

Masaki YoshidaDepartment of Urology, National Center for Geriatrics and Gerontology, Obu City, Japan.ORCID 0000-0002-9057-2277
Masayuki TakedaDepartment of Urology, University of Yamanashi, Graduate School of Medical Sciences, Yamanashi, Japan.
Momokazu GotohDepartment of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.ORCID 0000-0003-1839-6851
Osamu YokoyamaDepartment of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.
Hidehiro KakizakiDepartment of Renal and Urologic Surgery, Asahikawa Medical University, Hokkaido, Japan.ORCID 0000-0002-4340-9426
Satoru TakahashiDepartment of Urology, Nihon University School of Medicine, Tokyo, Japan.ORCID 0000-0002-0819-9478
Naoya MasumoriDepartment of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan.
Shinji NagaiMedical Affairs, Kyorin Pharmaceutical Co., Ltd., Toyko, Japan.
Kazuyoshi MinemuraMedical Affairs, Kyorin Pharmaceutical Co., Ltd., Toyko, Japan.ORCID 0000-0002-8359-2907
Toa Pharmaceutical (Japan) · JPAsahikawa Medical University · JPNagoya University · JPNational Center for Geriatrics and Gerontology · JPNihon University · JPSapporo Medical University · JPUniversity of Fukui · JPUniversity of Yamanashi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo examine the safety and efficacy of vibegron, a new β3-adrenoceptor agonist, in patients aged ≥65 years, with a focus on the effects on cardiovascular system and overactive bladder (OAB) symptoms.

methodsA post-hoc subgroup analysis was performed of a randomized, placebo-controlled, double-blind comparative phase 3 study of vibegron, including those assigned to receive either vibegron 50 mg (V50), vibegron 100 mg (V100), or placebo for 12 weeks. Subjects were stratified into two subgroups based on age: a <65-year subgroup and a ≥65-year subgroup. Safety (changes in systolic and diastolic blood pressure, pulse rate, and residual urine volume) and efficacy (changes in the numbers of micturitions, urgency episodes, urgency urinary incontinence [UUI] episodes, and the voided volume/micturition) were assessed in the subgroups treated with vibegron vs. placebo.

resultsThere were no significant differences in the cardiovascular outcomes (blood pressure and pulse rate), nor in the changes in residual urine volume, between the V50/100 and placebo groups in the <65-year or ≥65-year subgroup after 12-week treatment. Adverse events were slightly increased in the ≥65-year subgroup. In the efficacy analysis, V50/100 demonstrated similar efficacy in the <65-year and ≥65-year subgroups; an increasing trend in the voided volume/micturition was observed in subjects aged ≥65 years compared to subjects aged <65 years.

conclusionsVibegron was suggested to be similarly effective in patients ≥65 and <65 years and to have minimal influence on cardiovascular parameters.

Indexed as

Cardiovascular SystemUrinary Bladder, OveractiveAdrenergic beta-3 Receptor AgonistsAgedDouble-Blind MethodHumansMiddle AgedMuscarinic AntagonistsPyrimidinonesPyrrolidinesReceptors, AdrenergicTreatment OutcomeAdrenergic beta-3 Receptor AgonistsMuscarinic AntagonistsN-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamidePyrimidinonesPyrrolidinesReceptors, Adrenergicagingpharmacological therapysubgroupurinary symptomurinary urgency

Identifiers

PMID34139038
PMCPMC8362047
OpenAlexW3167165729

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.