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

Autor: Risha Govind, Nomi Werbeloff, Ehtesham Iqbal, Chi Hun Kim, Robert Stewart, Tanya Smith, Matthew Broadbent, Richard Dobson, Alvin Romero, Zina M. Ibrahim, Olubanke Dzahini, James H. MacCabe
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Hospitals
Psychiatric
Male
FOS: Computer and information sciences
Databases
Factual
Otology
Weight Gain
Piperazines
Benzodiazepines
0302 clinical medicine
Heart Rate
Tachycardia
Medicine and Health Sciences
Clozapine
Multidisciplinary
Middle Aged
Risperidone
Hospitals
3. Good health
Research Design
Olanzapine
Schizophrenia
Vertigo
Medicine
Female
medicine.symptom
Information Retrieval (cs.IR)
Research Article
Antipsychotic Agents
medicine.drug
Adult
medicine.medical_specialty
Side effect
Clinical Research Design
Sedation
Science
Cardiology
Pain
Research and Analysis Methods
Statistics - Applications
Computer Science - Information Retrieval
03 medical and health sciences
Signs and Symptoms
Adverse Reactions
Statistical significance
Mental Health and Psychiatry
medicine
Humans
Applications (stat.AP)
Adverse effect
Pharmacology
business.industry
Infant
medicine.disease
Mental health
Abdominal Pain
030227 psychiatry
Health Care
Clinical trial
Thiazoles
Otorhinolaryngology
Health Care Facilities
Age Groups
People and Places
Emergency medicine
Population Groupings
Adverse Events
Clinical Medicine
business
030217 neurology & neurosurgery
Zdroj: PLoS ONE, Vol 15, Iss 12, p e0243437 (2020)
PLoS ONE
Popis: 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.
Databáze: OpenAIRE
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