Evidence map›Paper›PMID 35438459›Full record

ArticleDrug safety2022

Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study.

Richard L Morrow, Barbara Mintzes, Patrick C Souverein, Christine E Hallgreen, Bilal Ahmed, Elizabeth E Roughead, Marie L De Bruin, Sarah Brøgger Kristiansen, Joel Lexchin, Anna Kemp-Casey and 9 more

Abstract read
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In one paragraph

Article in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

19 authors.

Richard L MorrowDepartment of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada. richard.morrow@ubc.ca.ORCID 0000-0002-5869-5197
Barbara MintzesFaculty of Medicine and Health and Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, NSW, Australia.
Patrick C SouvereinDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Christine E HallgreenDepartment of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark.
Bilal AhmedDepartment of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada.
Elizabeth E RougheadClinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.
Marie L De BruinDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Sarah Brøgger KristiansenDepartment of Drug Design and Pharmacology, Pharmacovigilance Research Center, University of Copenhagen, Copenhagen, Denmark.
Joel LexchinFaculty of Health, York University, Toronto, ON, Canada.
Anna Kemp-CaseyClinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.
Ingrid SketrisDepartment of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada.
Dee ManginDepartment of Family Medicine, McMaster University, Hamilton, ON, Canada.
Sallie-Anne PearsonFaculty of Medicine, Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.
Lorri PuilFaculty of Medicine, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
Ruth LopertDepartment of Health Policy and Management, George Washington University, Washington, DC, USA.
Lisa BeroSchool of Medicine and Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Danijela GnjidicFaculty of Medicine and Health and Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, NSW, Australia.
Ameet SarpatwariDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Colin R DormuthDepartment of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 210-1110 Government St., Victoria, BC, V8W 1Y2, Canada.

Funding

CIHR PJT–153275
6 · The paper itself

Abstract

introductionRegulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories.

methodsWe conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017).

resultsThis study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors.

conclusionHydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Indexed as

Long QT SyndromeTorsades de PointesCanadaCohort StudiesDNA-Binding ProteinsElectrocardiographyHumansHydroxyzineLongitudinal StudiesUnited KingdomDNA-Binding ProteinsHydroxyzine

Identifiers

PMID35438459
PMCPMC9189086

What Socratic holds

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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.