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, Richard J.B. Dobson, Zina M. Ibrahim

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

Objective Mining 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 methods We 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). Results Sedation, 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. Conclusion A better understanding of how drugs work in the real world can complement clinical trials.

Original languageEnglish
Article numbere0243437
JournalPLoS ONE
Volume15
Issue number12 December
DOIs
StatePublished - Dec 2020
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2020 Iqbal et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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