Evidence map›Paper›PMID 26350642›Full record

ArticleDrug safety2015

Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Proton Pump Inhibitors, or Metoclopramide: A Population-Based Nested Case-Control Study.

Alejandro Arana, Catherine B Johannes, Lisa J McQuay, Cristina Varas-Lorenzo, Daniel Fife, Kenneth J Rothman

Open access · hybridAbstract read
In one paragraph

Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Alejandro AranaEpidemiology, RTI Health Solutions, Barcelona, Spain.
Catherine B JohannesEpidemiology, RTI Health Solutions, 1440 Main Street, Suite 310, Waltham, MA, 02451, USA. cjohannes@rti.org.
Lisa J McQuayEpidemiology, RTI Health Solutions, Research Triangle Park, NC, USA.
Cristina Varas-LorenzoEpidemiology, RTI Health Solutions, Barcelona, Spain.
Daniel FifePharmaceutical Research and Development, Janssen Research & Development, LLC, Titusville, NJ, USA.
Kenneth J RothmanEpidemiology, RTI Health Solutions, 1440 Main Street, Suite 310, Waltham, MA, 02451, USA.
RTI Health Solutions · USJanssen (United States) · USResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpidemiological studies have linked domperidone use with serious cardiac arrhythmias, including sudden cardiac death, but data on age, dose, and duration of use are limited.

objectivesThe aim of this study was to assess the risk of out-of-hospital sudden cardiac death associated with domperidone use versus proton pump inhibitors (PPIs), metoclopramide, or non-use of all three medications, and to evaluate the risk of sudden cardiac death in relation to age and domperidone dose.

methodsThis was a population-based case-control study nested in a cohort of subjects aged ≥2 years in the Clinical Practice Research Datalink with one or more prescriptions for domperidone, any PPI, or metoclopramide from 2005 to 2011. Out-of-hospital sudden cardiac death was assessed by linkage with Hospital Episode Statistics and death certificates. Controls were matched on age, sex, and medical practice. The risk of sudden cardiac death in domperidone users versus risk in users of PPIs or metoclopramide was evaluated with multivariable conditional logistic regression; case-crossover analysis addressed possible residual confounding.

resultsFrom the study cohort (n = 681,104), 3239 sudden cardiac death cases were matched to 12,572 controls. The adjusted odds ratio (95 % confidence interval) for sudden cardiac death with current use of domperidone alone was 1.71 (0.92-3.18) versus non-use of study medications, 1.26 (0.68-2.34) versus current PPI use, and 0.40 (0.17-0.94) current metoclopramide use. The adjusted odds ratio (95 % confidence interval) relative to exposure to no study drug for domperidone >30 mg/day (eight cases, five controls) was 3.20 (0.59-17.3) and 1.65 (0.89-3.07) for age ≥61 years (27 cases, 49 controls). The odds ratio (95 % confidence interval) was 3.17 (1.72-5.83) for within-person periods of domperidone use versus non-use in the case-crossover analysis.

conclusionsCompared with non-use of any study drug, current domperidone use was associated with sudden cardiac death in nested case-control and case-crossover analyses, with a suggestion of higher risk in older persons and users of higher daily doses.

Indexed as

AgingAntiemeticsCase-Control StudiesDeath, Sudden, CardiacDomperidoneDose-Response Relationship, DrugDrug Administration ScheduleHumansMetoclopramideOdds RatioProton Pump InhibitorsRisk FactorsUnited KingdomAntiemeticsDomperidoneMetoclopramideProton Pump Inhibitors

Identifiers

PMID26350642
PMCPMC4659849
OpenAlexW1815145456

What OpenQuestion 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 OpenQuestion graph.