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Active monitoring of 12760 clozapine recipients in the UK and Ireland

Beyond pharmacovigilance

Published online by Cambridge University Press:  03 January 2018

Janet Munro ,
Desmond O'Sullivan ,
Christopher Andrews ,
Alejandro Arana ,
Ann Mortimer  and
Robert Kerwin
Janet Munro
Affiliation:
Institute of Psychiatry, London
Desmond O'Sullivan
Affiliation:
Novartis Pharmaceuticals UK Ltd, Frimley, Surrey
Christopher Andrews
Affiliation:
Novartis Pharmaceuticals UK Ltd, Frimley, Surrey
Alejandro Arana
Affiliation:
Global Epidemiology, Novartis Farmaceutica SA, Barcelona, Spain
Ann Mortimer
Affiliation:
University of Hull, Hull
Robert Kerwin*
Affiliation:
Institute of Psychiatry, London
*
Dr R. Kerwin, Institute of Psychiatry, De Crespigny Park, London SE5 8AF
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Abstract

Background

People prescribed clozapine for treatment-resistant schizophrenia have mandatory haematological monitoring through a case register for identifying reversible neutropenia.

Aims

To quantify risk factors for agranulocytosis in subjects receiving clozapine.

Method

Data from 12 760 subjects registered to receive clozapine from January 1990 to April 1997 were analysed. Risk factors for agranulocytosis were quantified using a Cox proportional-hazards regression analysis.

Results

The risk for agranulocytosis in Asian subjects was 2.4 times that in Caucasians (P=0.03). There was an age-related increase in risk of 53% per decade (P=0.0001).

Conclusions

The case register yielded valuable information for guiding research into the causes of the haematological reactions.

Type
Papers
Information
The British Journal of Psychiatry , Volume 175 , Issue 6 , December 1999 , pp. 576 - 580
Copyright
Copyright © 1999 The Royal College of Psychiatrists 

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Footnotes

Declaration of interest

The Clozaril Patient Monitoring Service is part of Novartis Pharmaceuticals. Three authors (D.O'S., C. A., A. A.) are employed by Novartis and three (J. M., A. M., R. K.) are in receipt of research grants from the company.

References

Alvir, J. J., Lieberman, J. A., Schwimmer, J. L., et al (1993) Clozapine-induced agranulocytosis: incidence and risk factors in the United States. New England Journal of Medicine, 329, 162–167.Google Scholar
Anderson, C., Connelly, J., Johnstone, E. C., et al (1991) Disabilities and circumstances of schizophrenic patients – a follow-up study. V: Cause of death. British Journal of Psychiatry, 159 (suppl. 13), 30–33.Google Scholar
Atkin, K, Kendall, F., Gould, D., et al (1996) Neutropenia and agranulocytosis in patients receiving clozapine in the UK and Ireland. British Journal of Psychiatry, 169, 483–488.Google Scholar
Black, D. W. & Fisher, R. (1992) Mortality in DSM–III–R schizophrenia. Schizophrenia Research, 7, 109–116.Google Scholar
Breslow, N. E. & Day, N. E. (1987) Statistical Methods in Cancer Research. Volume II: The Design and Analysis of Cohort Studies, pp. 69–72. Lyon: International Agency for Research on Cancer.Google Scholar
Cytet Software (1995) StatXact-3 for Windows. Cambridge, MA: Cytel Software Corporation.Google Scholar
Harris, E. C. & Barractough, B. (1998) Excess mortality of mental disorder. British Journal of Psychiatry, 173, 11–53.Google Scholar
Helgason, L. (1990) Twenty years' follow-up of first psychiatric presentation for schizophrenia: what could have been prevented? Acta Psychiatrica Scandinavica, 81, 231–235.Google Scholar
Honigfeld, G. (1996) Effects of the Clozapine National Registry System on incidence of deaths related to agranulocytosis. Psychiatric Services, 47, 52 56.Google Scholar
Meitzer, H. Y. & Okayli, G. (1995) Reduction of suicidally during clozapine treatment of neuroleptic-resistant schizophrenia: impact on risk–benefit assessment. American Journal of Psychiatry, 152, 183–190.Google Scholar
Mortansen, P. B. & Juel, K. (1993) Mortality and causes of death in first admitted schizophrenic patients. British Journal of Psychiatry, 163, 183–189.Google Scholar
Newman, S. C. & Bland, R. C. (1991) Mortality in a cohort of patients with schizophrenia: a record linkage study. Canadian Journal of Psychiatry, 36, 239–245.Google Scholar
Office for National Statistics (1995) Mortality Statistics: General, England and Wales, 1993, 1994, 1995. London: HMSO.Google Scholar
Registrar General (1997) Review of the Registrar General on Deaths in England and Wales, 1993–1995. Series DHI, no. 28. London: Stationery Office.Google Scholar
SAS Institute (1996) SAS/STAT. Version 6.12. Cary, NC: SAS Institute.Google Scholar
Tsoi, W. F. & Wong, K. E. (1991) A 15-year follow-up study of Chinese schizophrenic patients. Acta Psychiatrica Scandinavica, 84, 217–220.Google Scholar
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