Evidence map›Paper›PMID 33290433›Full record

ArticlePloS one2020

The side effect profile of Clozapine in real world data of three large mental health hospitals.

Ehtesham Iqbal, Risha Govind, Alvin Romero, Olubanke Dzahini, Matthew Broadbent, Robert Stewart, Tanya Smith, Chi-Hun Kim, Nomi Werbeloff, James H MacCabe and 2 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 4% 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

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

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  18. Metabolic Adverse Effects of Psychotropic Drug Therapy: A Systematic Review.European journal of investigation in health, psychology and education · 2023
    Review
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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

12 authors at 5 institutions in 1 country.

Ehtesham IqbalThe Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.ORCID 0000-0001-9477-9745
Risha GovindThe Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.ORCID 0000-0001-9925-7866
Alvin RomeroSLAM BioResource for Mental Health, South London and Maudsley NHS Foundation Trust and King's College London, London, United Kingdom.
Olubanke DzahiniPharmacy Department, South London and Maudsley NHS Foundation Trust, London, United Kingdom.ORCID 0000-0003-3878-2143
Matthew BroadbentNIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation, London, United Kingdom.
Robert StewartNIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation, London, United Kingdom.
Tanya SmithOxford Health NHS Foundation Trust, Oxford, United Kingdom.
Chi-Hun KimDepartment of Psychiatry, University of Oxford, Oxford, United Kingdom.
Nomi WerbeloffUCL Division of Psychiatry, University College London, London, United Kingdom.
James H MacCabeNIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation, London, United Kingdom.
Richard J B DobsonThe Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.
Zina M IbrahimThe Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.
King's College London · GBSouth London and Maudsley NHS Foundation Trust · GBOxford Health NHS Foundation Trust · GBUniversity College London · GBUniversity of Oxford · GB

Funding

Cancer Research UKChief Scientist OfficeDepartment of HealthMedical Research Council MC_PC_17214Medical Research Council MR/K006584/1Medical Research Council MR/T045302/1Wellcome Trust
6 · The paper itself

Abstract

objectiveMining the data contained within Electronic Health Records (EHRs) can potentially generate a greater understanding of medication effects in the real world, complementing what we know from Randomised control trials (RCTs). We Propose a text mining approach to detect adverse events and medication episodes from the clinical text to enhance our understanding of adverse effects related to Clozapine, the most effective antipsychotic drug for the management of treatment-resistant schizophrenia, but underutilised due to concerns over its side effects. MATERIAL AND

methodsWe used data from de-identified EHRs of three mental health trusts in the UK (>50 million documents, over 500,000 patients, 2835 of which were prescribed Clozapine). We explored the prevalence of 33 adverse effects by age, gender, ethnicity, smoking status and admission type three months before and after the patients started Clozapine treatment. Where possible, we compared the prevalence of adverse effects with those reported in the Side Effects Resource (SIDER).

resultsSedation, fatigue, agitation, dizziness, hypersalivation, weight gain, tachycardia, headache, constipation and confusion were amongst the highest recorded Clozapine adverse effect in the three months following the start of treatment. Higher percentages of all adverse effects were found in the first month of Clozapine therapy. Using a significance level of (p< 0.05) our chi-square tests show a significant association between most of the ADRs and smoking status and hospital admission, and some in gender, ethnicity and age groups in all trusts hospitals. Later we combined the data from the three trusts hospitals to estimate the average effect of ADRs in each monthly interval. In gender and ethnicity, the results show significant association in 7 out of 33 ADRs, smoking status shows significant association in 21 out of 33 ADRs and hospital admission shows the significant association in 30 out of 33 ADRs.

conclusionA better understanding of how drugs work in the real world can complement clinical trials.

Indexed as

AdultAntipsychotic AgentsBenzodiazepinesClozapineDatabases, FactualFemaleHospitals, PsychiatricHumansInfantMaleMiddle AgedOlanzapinePiperazinesRisperidoneSchizophreniaThiazolesAntipsychotic AgentsBenzodiazepinesClozapineOlanzapinePiperazinesRisperidoneThiazoles

Identifiers

PMID33290433
PMCPMC7723266
OpenAlexW3110701940

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.