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

Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database
Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database
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.
1471-244X
135
Coupland, Carol
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Morriss, Richard
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Arthur, Antony
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Moore, Michael
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Hill, Trevor
7c347407-2cde-4145-9a38-6e4258af6982
Hippisley-Cox, Julia
7be524e3-9066-4179-b58f-cb2e16cd02ec
Coupland, Carol
6efd69d5-8f84-45ac-9777-d4b07feeb2e2
Morriss, Richard
fb48ce6f-f557-4e5d-a309-5eb7f6ee6c2e
Arthur, Antony
90ae53fb-349a-445a-8527-a3bba857a2d7
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Hill, Trevor
7c347407-2cde-4145-9a38-6e4258af6982
Hippisley-Cox, Julia
7be524e3-9066-4179-b58f-cb2e16cd02ec

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, 135. (doi:10.1186/1471-244X-13-135). (PMID:23663769)

Record type: Article

Abstract

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.

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Published date: 10 May 2013
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 357387
URI: https://eprints.soton.ac.uk/id/eprint/357387
ISSN: 1471-244X
PURE UUID: ee59b359-9afd-47f3-8f62-0cfeba29a439
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 25 Sep 2013 11:25
Last modified: 03 Dec 2019 01:47

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