Evidence map›Paper›PMID 31556019›Full record

ArticleDrug safety2019

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy.

Janet Sultana, Andrea Fontana, Francesco Giorgianni, Silvia Tillati, Claudio Cricelli, Alessandro Pasqua, Elisabetta Patorno, Clive Ballard, Miriam Sturkenboom, Gianluca Trifirò

Abstract read
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In one paragraph

Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Article
  4. Article
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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

10 authors.

Janet SultanaDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy.ORCID http://orcid.org/0000-0001-9622-169X
Andrea FontanaFondazione IRCCS Casa Sollievo della Sofferenza, Unit of Biostatistics, Viale Cappuccini, 2, 71013, San Giovanni Rotondo, FG, Italy.
Francesco GiorgianniDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy.
Silvia TillatiDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy.
Claudio CricelliHealth Search, Italian College of General Practitioners, Sestese Street, 61, 50141, Florence, Italy.
Alessandro PasquaHealth Search, Italian College of General Practitioners, Sestese Street, 61, 50141, Florence, Italy.
Elisabetta PatornoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
Clive BallardUniversity of Exeter Medical School, Medical School Building, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK.
Miriam SturkenboomJulius Centre for Global Health, Utrecht University Medical Centre, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Gianluca TrifiròDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy. trifirog@unime.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSafety warnings relating to antipsychotic-associated stroke among older persons in the UK and Italy were issued. However, the impact of these safety warnings on stroke risk has not been measured to date.

objectiveThe aim of this study was to measure the change in stroke incidence after two safety warnings in both the UK and Italy.

methodA cohort study was conducted using electronic medical records representative of the UK (The Health Improvement Network) and Italy (Health Search-IQVIA Health LPD), containing data on 11 million and 1 million patients, respectively. After each drug safety warning, elderly antipsychotic new initiators were propensity-score matched 1:1:1 on antipsychotic initiators before any safety warning. Stroke incidence within 6 months of antipsychotic initiation, using an intention-to-treat approach, was the main outcome.

resultsIn the UK and Italy, 6342 and 7587 elderly antipsychotic initiators were identified, respectively. A 42% stroke incidence reduction was seen in the UK after the first safety warning [42.3 (95% confidence interval (CI) 35.2-50.8) vs. 24.4 [95% CI 19.0-31.2] events per 1000 person-years (PYs)], while there was a 60% stroke incidence reduction after the second warning (16.9 [95% CI 12.2-23.4] events per 1000 PYs) compared to before the first warning. There was no significant reduction in stroke incidence in Italy.

conclusionAntipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy.

Indexed as

Drug LabelingAgedAged, 80 and overAntipsychotic AgentsCohort StudiesDatabases, FactualElectronic Health RecordsFemaleHumansIncidenceItalyMalePatient SafetyRisk Reduction BehaviorStrokeUnited KingdomAntipsychotic Agents

Identifiers

PMID31556019

What OpenQuestion holds

Textmetadata
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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.