The side effect profile of Clozapine in real world data of three large mental health hospitals
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 epis...
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| Veröffentlicht in: | PloS one 2020-12, Vol.15 (12), p.e0243437 |
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| creator | Iqbal, Ehtesham Govind, Risha Romero, Alvin Dzahini, Olubanke Broadbent, Matthew Stewart, Robert Smith, Tanya Kim, Chi-Hun Werbeloff, Nomi MacCabe, James H Dobson, Richard J B Ibrahim, Zina M |
| description | 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.
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).
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.
A better understanding of how drugs work in the real world can complement clinical trials. |
| doi_str_mv | 10.1371/journal.pone.0243437 |
| format | Article |
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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).
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.
A better understanding of how drugs work in the real world can complement clinical trials.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0243437</identifier><identifier>PMID: 33290433</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject><![CDATA[Adult ; Adverse drug reactions ; Antipsychotic Agents - adverse effects ; Antipsychotics ; Benzodiazepines - administration & dosage ; Benzodiazepines - adverse effects ; Biomedical research ; Cardiomyopathy ; Clinical trials ; Clozapine ; Clozapine - administration & dosage ; Clozapine - adverse effects ; Complications and side effects ; Constipation ; Data mining ; Databases, Factual ; Dementia ; Diabetes ; Drug stores ; Drug therapy ; Electronic health records ; Electronic medical records ; Ethnicity ; Female ; Gender ; Health informatics ; Health services ; Hospitals ; Hospitals, Psychiatric ; Humans ; Hypertension ; Infant ; Male ; Medicine and Health Sciences ; Mental disorders ; Mental health ; Middle Aged ; Minority & ethnic groups ; Neurosciences ; Olanzapine - administration & dosage ; Olanzapine - adverse effects ; Patient admissions ; Patients ; People and Places ; Piperazines - administration & dosage ; Piperazines - adverse effects ; Psychiatry ; Psychotropic drugs ; Research and Analysis Methods ; Risk factors ; Risperidone - administration & dosage ; Risperidone - adverse effects ; Schizophrenia ; Schizophrenia - complications ; Schizophrenia - drug therapy ; Schizophrenia - physiopathology ; Side effects ; Smoking ; Statistics ; Tachycardia ; Thiazoles - administration & dosage ; Thiazoles - adverse effects ; Weight Gain - drug effects]]></subject><ispartof>PloS one, 2020-12, Vol.15 (12), p.e0243437</ispartof><rights>COPYRIGHT 2020 Public Library of Science</rights><rights>2020 Iqbal et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 Iqbal et al 2020 Iqbal et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-8f3146cb7292e03eba0fcb9eee90044772e0332cba6b32c0481296a4d515e1163</citedby><cites>FETCH-LOGICAL-c692t-8f3146cb7292e03eba0fcb9eee90044772e0332cba6b32c0481296a4d515e1163</cites><orcidid>0000-0003-3878-2143 ; 0000-0001-9925-7866 ; 0000-0001-9477-9745</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723266/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723266/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33290433$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>De Luca, Vincenzo</contributor><creatorcontrib>Iqbal, Ehtesham</creatorcontrib><creatorcontrib>Govind, Risha</creatorcontrib><creatorcontrib>Romero, Alvin</creatorcontrib><creatorcontrib>Dzahini, Olubanke</creatorcontrib><creatorcontrib>Broadbent, Matthew</creatorcontrib><creatorcontrib>Stewart, Robert</creatorcontrib><creatorcontrib>Smith, Tanya</creatorcontrib><creatorcontrib>Kim, Chi-Hun</creatorcontrib><creatorcontrib>Werbeloff, Nomi</creatorcontrib><creatorcontrib>MacCabe, James H</creatorcontrib><creatorcontrib>Dobson, Richard J B</creatorcontrib><creatorcontrib>Ibrahim, Zina M</creatorcontrib><title>The side effect profile of Clozapine in real world data of three large mental health hospitals</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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.
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).
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.
A better understanding of how drugs work in the real world can complement clinical trials.</description><subject>Adult</subject><subject>Adverse drug reactions</subject><subject>Antipsychotic Agents - adverse effects</subject><subject>Antipsychotics</subject><subject>Benzodiazepines - administration & dosage</subject><subject>Benzodiazepines - adverse effects</subject><subject>Biomedical research</subject><subject>Cardiomyopathy</subject><subject>Clinical trials</subject><subject>Clozapine</subject><subject>Clozapine - administration & dosage</subject><subject>Clozapine - adverse effects</subject><subject>Complications and side effects</subject><subject>Constipation</subject><subject>Data mining</subject><subject>Databases, Factual</subject><subject>Dementia</subject><subject>Diabetes</subject><subject>Drug stores</subject><subject>Drug therapy</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Ethnicity</subject><subject>Female</subject><subject>Gender</subject><subject>Health informatics</subject><subject>Health services</subject><subject>Hospitals</subject><subject>Hospitals, Psychiatric</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Infant</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Mental disorders</subject><subject>Mental health</subject><subject>Middle Aged</subject><subject>Minority & ethnic groups</subject><subject>Neurosciences</subject><subject>Olanzapine - administration & dosage</subject><subject>Olanzapine - adverse effects</subject><subject>Patient admissions</subject><subject>Patients</subject><subject>People and Places</subject><subject>Piperazines - administration & dosage</subject><subject>Piperazines - adverse effects</subject><subject>Psychiatry</subject><subject>Psychotropic drugs</subject><subject>Research and Analysis Methods</subject><subject>Risk 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Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Iqbal, Ehtesham</au><au>Govind, Risha</au><au>Romero, Alvin</au><au>Dzahini, Olubanke</au><au>Broadbent, Matthew</au><au>Stewart, Robert</au><au>Smith, Tanya</au><au>Kim, Chi-Hun</au><au>Werbeloff, Nomi</au><au>MacCabe, James H</au><au>Dobson, Richard J B</au><au>Ibrahim, Zina M</au><au>De Luca, Vincenzo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The side effect profile of Clozapine in real world data of three large mental health hospitals</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2020-12-08</date><risdate>2020</risdate><volume>15</volume><issue>12</issue><spage>e0243437</spage><pages>e0243437-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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.
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).
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.
A better understanding of how drugs work in the real world can complement clinical trials.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33290433</pmid><doi>10.1371/journal.pone.0243437</doi><tpages>e0243437</tpages><orcidid>https://orcid.org/0000-0003-3878-2143</orcidid><orcidid>https://orcid.org/0000-0001-9925-7866</orcidid><orcidid>https://orcid.org/0000-0001-9477-9745</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2020-12, Vol.15 (12), p.e0243437 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2468202725 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Adverse drug reactions Antipsychotic Agents - adverse effects Antipsychotics Benzodiazepines - administration & dosage Benzodiazepines - adverse effects Biomedical research Cardiomyopathy Clinical trials Clozapine Clozapine - administration & dosage Clozapine - adverse effects Complications and side effects Constipation Data mining Databases, Factual Dementia Diabetes Drug stores Drug therapy Electronic health records Electronic medical records Ethnicity Female Gender Health informatics Health services Hospitals Hospitals, Psychiatric Humans Hypertension Infant Male Medicine and Health Sciences Mental disorders Mental health Middle Aged Minority & ethnic groups Neurosciences Olanzapine - administration & dosage Olanzapine - adverse effects Patient admissions Patients People and Places Piperazines - administration & dosage Piperazines - adverse effects Psychiatry Psychotropic drugs Research and Analysis Methods Risk factors Risperidone - administration & dosage Risperidone - adverse effects Schizophrenia Schizophrenia - complications Schizophrenia - drug therapy Schizophrenia - physiopathology Side effects Smoking Statistics Tachycardia Thiazoles - administration & dosage Thiazoles - adverse effects Weight Gain - drug effects |
| title | The side effect profile of Clozapine in real world data of three large mental health hospitals |
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