Evidence map›Paper›PMID 32431551›Full record

ArticleClinical epidemiology2020

Evaluating the Effectiveness of an Additional Risk Minimization Measure to Reduce the Risk of Prescribing Mirabegron to Patients with Severe Uncontrolled Hypertension in Four European Countries.

Edith M Heintjes, Irene D Bezemer, Daniel Prieto-Alhambra, Elisabeth Smits, Helen P Booth, Daniel Dedman, Ying He, Fabian Hoti, Minna Vehkala, Stefan de Vogel and 3 more

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Article in Clinical epidemiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Observational
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

13 authors.

Edith M HeintjesPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.ORCID 0000-0002-2617-3845
Irene D BezemerPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
Daniel Prieto-AlhambraIdiap Jordi Gol Primary Care Research Institute and CIBERFes, Universitat Autonoma de Barcelona and Instituto de Salud Carlos III, Barcelona, Catalonia, Spain.
Elisabeth SmitsPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
Helen P BoothClinical Practice Research Datalink (CPRD), London, UK.
Daniel DedmanClinical Practice Research Datalink (CPRD), London, UK.ORCID 0000-0002-3699-5391
Ying HeCentre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, England, UK.
Fabian HotiStatfinn - EPID Research, Espoo, Finland.
Minna VehkalaStatfinn - EPID Research, Espoo, Finland.
Stefan de VogelAstellas Pharma Europe B.V., Leiden, Netherlands.
Noah Jamie RobinsonAstellas Pharma Europe B.V., Leiden, Netherlands.
Kwame AppentengAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Fernie J A Penning-van BeestPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMirabegron, indicated for the treatment of overactive bladder, is contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg). In September 2015, a Direct Healthcare Professional Communication (DHPC) letter was disseminated as an additional risk minimisation measure. PURPOSE: To assess the effectiveness of the DHPC in reducing the proportions of patients with severe or non-severe uncontrolled hypertension at mirabegron initiation.

methodsAn observational multi-database cohort study was undertaken using routinely collected healthcare data (December 2012-December 2016) from the PHARMO Database Network (Netherlands), SIDIAP database (Spain), CPRD (United Kingdom, UK) and national healthcare registers and electronic medical records from Finland. DHPC effectiveness was evaluated using interrupted time series analyses comparing trends and changes in monthly proportions of severe or non-severe uncontrolled hypertensive mirabegron initiations relative to the timing of the DHPC dissemination.

resultsThe study population comprised 52,078 patients. Prior to DHPC dissemination, across the four databases, 0.3-1.3% had severe uncontrolled hypertension. Estimated absolute changes (EAC) in proportions of severe uncontrolled hypertension post-DHPC indicated a tendency towards a lower proportion in the Netherlands (EAC -0.36%,

conclusionSevere uncontrolled hypertension prior to mirabegron initiation was uncommon in these four European countries even before DHPC dissemination. This suggests that other risk minimisation communications (prior to the DHPC dissemination) had worked adequately with respect to minimising mirabegron use among patients with severe uncontrolled hypertension. No strong and consistent evidence of further risk minimisation after the DHPC dissemination was observed in this study.

Indexed as

direct healthcare professional communicationdrug utilisation studyinterrupted time series analysisrisk minimization

Identifiers

PMID32431551
PMCPMC7200224

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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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 Socratic graph.