Hostname: page-component-cd9895bd7-gvvz8 Total loading time: 0 Render date: 2024-12-31T16:02:39.355Z Has data issue: false hasContentIssue false
  • English
  • Français

Utilisation of extended release quetiapine (Seroquel XL™): Results from an observational cohort study in England

Published online by Cambridge University Press:  23 March 2020

V. Osborne ,
M. Davies ,
D. Layton  and
S.A.W. Shakir
V. Osborne*
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Blundell LaneSouthamptonSO31 1AAUK
M. Davies
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Blundell LaneSouthamptonSO31 1AAUK
D. Layton
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Blundell LaneSouthamptonSO31 1AAUK
S.A.W. Shakir
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Blundell LaneSouthamptonSO31 1AAUK
*
⁎ Corresponding author. Tel./fax: +44 0 23 8040 8600. E-mail address:[email protected] (V. Osborne).
Get access

Abstract

Background

A post-authorisation safety study was carried out as part of the EU Risk Management Plan to examine the long-term (up to 12 months) use of quetiapine XL as prescribed in general practice in England.

Aim

To present a description of the drug utilisation characteristics of quetiapine XL.

Methods

An observational, population-based cohort design using the technique of Modified Prescription-Event Monitoring (M-PEM). Patients were identified from dispensed prescriptions issued by general practitioners (GPs) for quetiapine XL between September 2008 and February 2013. Questionnaires were sent to GPs 12 months following the 1st prescription for each individual patient, requesting drug utilisation information. Cohort accrual was extended to recruit additional elderly patients (special population of interest). Summary descriptive statistics were calculated.

Results

The final M-PEM cohort consisted of 13,276 patients; median age 43 years (IQR: 33, 55) and 59.0% females. Indications for prescribing included bipolar disorder (n = 3820), MDD (n = 2844), schizophrenia (n = 2373) and other (non-licensed) indications (n = 3750). Where specified, 59.3% (7869/13,276) were reported to have used quetiapine IR (immediate release formulation) previously at any time. The median start dose was highest for patients with schizophrenia (300 mg/day [IQR 150, 450]). The final elderly cohort consisted of 3127 patients and 28.5% had indications associated with dementia. The median start dose for elderly patients was highest for patients with schizophrenia or BD (both 100 mg/day [IQR 50, 300]).

Conclusions

The prevalence of off-label prescribing in terms of indication and high doses was common, as was use in special populations such as the very elderly. Whilst off-label use may be unavoidable in certain situations, GPs may need to re-evaluate prescribing in circumstances where there may be safety concerns. This study demonstrates the ongoing importance of observational studies such as M-PEM to gather real-world clinical data to support the post-marketing benefit:risk management of new medications, or existing medications for which license extensions have been approved.

Keywords

Mania and bipolar disorderSchizophrenia and psychosisEpidemiologyPsychopharmacology
Type
Original article
Information
European Psychiatry , Volume 33 , Issue 1 , March 2016 , pp. 61 - 67
Copyright
Copyright © European Psychiatric Association 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

European Medicines Agency, Guideline on good pharmacovigilance practices (GVP): module V – risk management systems (Rev 1) 2014Google Scholar
European Medicines Agency, Guideline on good pharmacovigilance practices (GVP): module VIII – post-authorisation safety studies (Rev 1) 2013Google Scholar
AstraZeneca UK Limited, Seroquel XL 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets: summary of product characteristics 2014 [Ref type: pamphlet]Google Scholar
AstraZeneca UK Limited, SEROQUEL 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets 2014 [Ref type: pamphlet]Google Scholar
Peuskens, J.Trivedi, J.Malyarov, S.Brecher, M.Svensson, O.Miller, F., et al.Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients Psychiatry 2007; 4(11): 34–50Google ScholarPubMed
Bui, K.Earley, W.Nyberg, S.Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications. Curr Med Res Opin 2013; 29(7): 813–825CrossRefGoogle ScholarPubMed
Hallinen, T.Soini, E.Granstrom, O.Leinonen, E.Koponen, H.Hanninen, K.Differential use of extended and immediate release quetiapine: a retrospective registry study of Finnish inpatients with schizophrenia spectrum and bipolar disorders. BMJ Open 2012; 2:e000915CrossRefGoogle ScholarPubMed
Layton, D.Hazell, L.Shakir, S.A.Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management. Drug Saf 2011; 34:e1–e9CrossRefGoogle ScholarPubMed
CIOMS/WHO, International guidelines for biomedical research involving human subjects Geneva: CIOMS; 2002 [Available from: URL: http://www.cioms.ch/publications/layout_guide2002.pdf]Google Scholar
Royal College of Physicians Guidelines on the practice of ethics committees in medical research involving human subjects 3rd ed 1996 Royal College of Physicians of London LondonGoogle Scholar
Health Research Authority, Advisory Group advice and approval decisions. Prescription-event monitoring, CAG ref: ECC 5-07(b)/2009 2013 HRA [Available from: URL: http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/cag-advice-and-approval-decisions/]Google Scholar
Yood, M.U.DeLorenze, G.Quesenberry, C.P. Jr.Oliveria, S.A.Tsai, A.L.Willey, V.J., et al.The incidence of diabetes in atypical antipsychotic users differs according to agent–results from a multisite epidemiologic study Pharmacoepidemiol Drug Saf 2009; 18(9): 791–799CrossRefGoogle ScholarPubMed
NICE, Schizophrenia – core interventions in the treatment and management of schizophrenia in adults in primary and secondary care 2009 [Report no.: clinical guideline 82]Google Scholar
NICE, Bipolar disorder – the management of bipolar disorder in adults, children and adolescents in primary and secondary care 2006 [Report no.: clinical guideline 38]Google Scholar
Royal College of Psychiatrists Consensus statement on high-dose antipsychotic medication 2006 [Report no.: council report CR138]Google Scholar
AstraZeneca, Seroquel XL: UK summary of product characteristics 2010Google Scholar
Banerjee, S.Good news on dementia prevalence – we can make a difference. Lancet 2013; 382: 1384–1386CrossRefGoogle Scholar
Health, I.M.S.The use of medicines in dementia care London: IMS; 2009Google Scholar
Child, A.Clarke, A.Fox, C.Maidment, I.A pharmacy led program to review antipsychotic prescribing for people with dementia. BMC Psychiatry 2012; 12:155CrossRefGoogle ScholarPubMed
National Institute for health and Care Excellence Low-dose antipsychotics in people with dementia 2015 NICE [Available from: URL: http://www.nice.org.uk/advice/ktt7/resources/lowdose-antipsychotics-in-people-with-dementia-1632175200709]Google Scholar
National Institute for health and Care Excellence Dementia: supporting people with dementia and their carers in health and social care 2015 NICE [Available from: URL: http://www.nice.org.uk/guidance/cg42/resources/guidance-dementia-pdf]Google Scholar
Joint Formulary Committee, British National Formulary (BNF) 69 2015 Pharmaceutical PressGoogle Scholar
McAvoy, B.Kaner, E.General practice postal surveys: a questionnaire too far?. BMJ 1996; 313(7059): 732–733CrossRefGoogle ScholarPubMed
Heeley, E.Riley, J.Layton, D.Wilton, L.Shakir, S.Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358(9296): 1872–1873CrossRefGoogle ScholarPubMed
Martin, R.Kapoor, K.Wilton, L.Mann, R.Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study. BMJ 1998; 317(7151): 119–120CrossRefGoogle ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.