Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database

Coupland, Carol, Morriss, Richard, Arthur, Antony, Moore, Michael, Hill, Trevor and Hippisley-Cox, Julia (2013) Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database. BMC Psychiatry, 13. ISSN 1471-244X

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Background: Antidepressants are among the most commonly prescribed drugs in primary care in England and their use is increasing. This is largely due to longer durations of treatment of depression. Observational studies have shown some differences in adverse outcomes associated with different antidepressant drugs but relatively little is known about their relative safety particularly with long term use. The primary aim of this study is to determine the relative and absolute risks of pre-defined adverse events comparing different classes of antidepressant drugs in adults aged under 65 years and diagnosed with depression. Methods/design: The study will identify a cohort of patients with a first recorded diagnosis of depression between 1/1/2000 and 31/07/2011, and made between the ages of 20 to 64 years using a large primary care database (QResearch). Patients will be followed up until 1/08/2012. Details of all prescriptions for antidepressants in patients in the cohort will be extracted, including the date of each prescription, the type of antidepressant drug, the dose and total quantity prescribed. Prospectively recorded data will be used to ascertain information on adverse outcomes that occurred during follow-up and after entry into the cohort. These are: all-cause mortality, suicide, attempted suicide/self-harm, sudden death, antidepressant overdose/poisoning, myocardial infarction, stroke/transient ischaemic attack, cardiac arrhythmia, epilepsy/seizures, upper gastrointestinal bleeding, falls, fractures, adverse drug reactions and motor vehicle crashes. Cox proportional hazard models will be used to estimate the association of the outcomes with class of antidepressant drug adjusting for potential confounding variables. The analyses will also examine associations by duration and dose and with the most frequently prescribed individual antidepressant drugs. Self-controlled case series analyses will be used to estimate the relative incidence of the outcomes of interest for defined time periods of antidepressant use. Discussion: The results of this study will help to establish the relative safety and balance of risks for different antidepressant drugs in people aged under 65.

Item Type: Article
Additional Information: The project is funded by the National Institute for Health Research’s School for Primary Care Research. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funding body did not play a role in the study design, writing of the manuscript or in the decision to submit the manuscript for publication.
Uncontrolled Keywords: antidepressants,depression,cohort,safety,sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School:
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Health in Later Life (former - to 2017)
Faculty of Medicine and Health Sciences > Research Groups > Dementia & Complexity in Later Life
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Depositing User: Pure Connector
Date Deposited: 23 Oct 2013 20:10
Last Modified: 31 Oct 2022 16:30
DOI: 10.1186/1471-244X-13-135


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