Evidence map›Paper›PMID 30079630›Full record

ArticleLower urinary tract symptoms2019

Three-year safety, efficacy and persistence data following the daily use of mirabegron for overactive bladder in the clinical setting: A Japanese post-marketing surveillance study.

Daisuke Kato, Hiromi Tabuchi, Satoshi Uno

Open access · hybridAbstract read
In one paragraph

Article in Lower urinary tract symptoms, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Observational
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Daisuke KatoMedical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
Hiromi TabuchiMedical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
Satoshi UnoJapan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.
Astellas Pharma (Japan) · JP

Funding

Astellas Pharma Global DevelopmentAstellas Pharma Inc.
6 · The paper itself

Abstract

objectiveThe aim of this study was to report the final 3-year results from a surveillance study evaluating the safety, efficacy, and persistence of mirabegron for treating overactive bladder (OAB) symptoms.

methodsPatients who had started mirabegron for the treatment of urinary urgency, daytime frequency, and urgency urinary incontinence symptoms associated with OAB were followed for 3 years. Adverse drug reactions (ADRs), residual urine volume measurements, OAB symptoms, Overactive Bladder Symptom Scores (OABSS), and treatment discontinuations were evaluated prospectively. Persistence was estimated using the Kaplan-Meier method.

resultsOf the 1138 patients included in the study (mean ±SD age: 71.9 ± 11.0 years; 574 [50.4%] women), 97 (8.52%) experienced 109 ADRs, with the incidence of ADRs decreasing over time (<1 year: 1.34%-2.37%; ≥1-<2 years: 0.45%-1.60%; ≥2-<3 years: 0.29%-1.10%; 3-monthly interval data). No significant increases in residual urine volume were observed. The investigators considered mirabegron to be an effective treatment for 842 of 1082 (77.8%) patients. Significant decreases in OABSS were reported throughout (P < 0.001), and 321 (65.1%) patients achieved a minimal clinically important change (MCIC) in OABSS. Most patients who achieved an MCIC within ≤1 year continued to maintain an MCIC throughout the study. Treatment persistence rates after 1, 2, and 3 years of mirabegron treatment were 65.8%, 52.9%, and 46.7%, respectively.

conclusionOver 3 years, mirabegron was well tolerated and no cumulative events or delayed ADRs were observed. Mirabegron was an effective treatment with early improvements in OABSS being maintained throughout the treatment period. High persistence was observed after the use of mirabegron.

Indexed as

AcetanilidesAgedFemaleHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingThiazolesTreatment OutcomeUrinary Bladder, OveractiveUrodynamicsUrological AgentsAcetanilidesmirabegronThiazolesUrological Agentsefficacymirabegronoveractive bladderpersistencesafety

Identifiers

PMID30079630
PMCPMC7379686
OpenAlexW2886244194

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.