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

详细信息    查看全文

• 作者：Carol Coupland (8)
  Richard Morriss (9)
  Antony Arthur (10)
  Michael Moore (11)
  Trevor Hill (8)
  Julia Hippisley-Cox (8)
  
• 关键词：Antidepressants ; Depression ; Cohort ; Safety
• 刊名：BMC Psychiatry
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：13
• 期：1
• 全文大小：170KB
• 参考文献：1. Health and Social Care Information Centre, Prescribing and Primary Care Services: / Prescriptions Dispensed in the Community: England, Statistics for 2001 to 2011. https://catalogue.ic.nhs.uk/publications/prescribing/primary/pres-disp-com-eng-2001-11/pres-disp-com-eng-2001-11-rep.pdf
  2. Health and Social Care Information Centre, Prescribing and Primary Care: / Prescription Cost Analysis England. 2012. https://catalogue.ic.nhs.uk/publications/prescribing/primary/pres-cost-anal-eng-2012/pres-cost-anal-eng-2012-rep.pdf
  3. Moore M, Yuen HM, Dunn N, Mullee MA, Maskell J, Kendrick T: Explaining the rise in antidepressant prescribing: a descriptive study using the general practice research database. / BMJ 2009, 339:b3999. CrossRef
  4. Lockhart P, Guthrie B: Trends in primary care antidepressant prescribing 1995鈥?007: a longitudinal population database analysis. / Br JGen Pract 2011, 61:e565-e572. CrossRef
  5. Arroll B, Elley CR, Fishman T, Goodyear-Smith FA, Kenealy T, Blashki G, Kerse N, MacGillivray S: Antidepressants versus placebo for depression in primary care. In / Cochrane Database of Systematic Reviews. Cochrane Database of Systematic Reviews: Reviews 2009 Issue 3. UK: John Wiley & Sons, Ltd Chichester; 2009.
  6. Jick H, Kaye JA, Jick SS: Antidepressants and the risk of suicidal behaviors. / JAMA 2004,292(3):338鈥?43. CrossRef
  7. Martinez C, Rietbrock S, Wise L, Ashby D, Chick J, Moseley J, Evans S, Gunnell D: Antidepressant treatment and the risk of fatal and non-fatal self harm in first episode depression: nested case鈥揷ontrol study. / BMJ 2005,330(7488):389. CrossRef
  8. Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes A, Hammad TA, Temple R, Rochester G: Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration. / BMJ 2009, 339:b2880. CrossRef
  9. Hippisley-Cox J, Pringle M, Hammersley V, Crown N, Wynn A, Meal A, Coupland C: Antidepressants as risk factor for ischaemic heart disease: case鈥揷ontrol study in primary care. / BMJ 2001,323(7314):666鈥?69. CrossRef
  10. Tata LJ, West J, Smith C, Farrington P, Card T, Smeeth L, Hubbard R: General population based study of the impact of tricyclic and selective serotonin reuptake inhibitor antidepressants on the risk of acute myocardial infarction. / Heart 2005,91(4):465鈥?71. CrossRef
  11. Chen Y, Guo JJ, Li H, Wulsin L, Patel NC: Risk of cerebrovascular events associated with antidepressant use in patients with depression: A population-based, nested case鈥揷ontrol study. / Ann Pharmacother 2008,42(2):177鈥?84. CrossRef
  12. Dalton SO, Johansen C, Mellemkjaer L, Norgard B, Sorensen HT, Olsen JH: Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study. / Arch Intern Med 2003,163(1):59鈥?4. CrossRef
  13. Coupland C, Dhiman P, Barton G, Morriss R, Arthur A, Sach T, Hippisley-Cox J: A study of the safety and harms of antidepressant drugs for older people: a cohort study analysis using a large primary care database. / Health Technol Assess 2011.,15(28): http://www.hta.ac.uk/fullmono/mon1528.pdf
  14. Abrams RC, Leon AC, Tardiff K, Marzuk PM, Li CS, Galea S: Antidepressant Use in elderly suicide victims in New york city: an analysis of 255 cases. / J Clin Psychiatry 2009,70(3):312鈥?17. CrossRef
  15. Hubbard R, Farrington P, Smith C, Smeeth L, Tattersfield A: Exposure to tricyclic and selective serotonin reuptake inhibitor antidepressants and the risk of Hip fracture. / Am J Epidemiol 2003,158(1):77鈥?4. CrossRef
  16. Liu B, Anderson G, Mittmann N, To T, Axcell T, Shear N: Use of selective serotonin-reuptake inhibitors of tricyclic antidepressants and risk of hip fractures in elderly people. / Lancet 1998,351(9112):1303鈥?307. CrossRef
  17. van Walraven C, Mamdani MM, Wells PS, Williams JI: Inhibition of serotonin reuptake by antidepressants and upper gastrointestinal bleeding in elderly patients: retrospective cohort study. / BMJ 2001,323(7314):655鈥?58. CrossRef
  18. Coupland C, Dhiman P, Morriss R, Arthur A, Barton G, Hippisley-Cox J: Antidepressant use and risk of adverse outcomes in older people: population based cohort study. / BMJ 2011, 343:d4551. CrossRef
  19. Altman DG, Andersen PK: Calculating the number needed to treat for trials where the outcome is time to an event. / BMJ 1999,319(7223):1492鈥?495. CrossRef
  20. Whitaker HJ, Farrington CP, Spiessens B, Musonda P: Tutorial in biostatistics: the self-controlled case series method. / Stat Med 2006,25(10):1768鈥?797. CrossRef
  21. Whitaker H: The self controlled case series method. / BMJ 2008,337(aug28_2):a1069. CrossRef
  22. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/13/135/prepub
  
• 作者单位：Carol Coupland (8)
  Richard Morriss (9)
  Antony Arthur (10)
  Michael Moore (11)
  Trevor Hill (8)
  Julia Hippisley-Cox (8)
  
  8. Division of Primary Care, University of Nottingham, 13th floor, Tower Building, University Park, Nottingham, NG7 2RD, UK
  9. Division of Psychiatry, University of Nottingham, Nottingham, UK
  10. School of Nursing Sciences, University of East Anglia, Norwich, UK
  11. Primary Care Research Network South West, University of Southampton, Southampton, UK
  

文摘

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.