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Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine

Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine
Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine
Sertindole (Serdolect), an atypical antipsychotic, was voluntarily suspended in the European Union in 1998 following regulatory concerns over reports of serious cardiac dysrhythmias and sudden unexpected deaths. The reported causes of death, their frequency, prolongation of the rate corrected QT interval (QTc) and cardiac dysrhythmias in patients prescribed sertindole were compared with those for patients treated with two other atypical antipsychotics. All patients in England, prescribed atypical antipsychotics by general practitioners during each drug's immediate post-marketing period, were identified using an observational cohort technique, prescription-event monitoring. Mortality rates in the sertindole cohort were compared with those in a comparator cohort using standardized mortality ratios and incidence rate ratios. Cardiovascular events were reviewed and followed up to identify cases of prolongation of QTc interval. There was no statistically significant difference in mortality rates between sertindole and the comparator cohort, although confidence intervals (CI) were wide due to small numbers in the sertindole cohort. A much smaller number of patients were prescribed sertindole than the other antipsychotics. Six cases of prolongation of QTc interval were identified in 462 patients (1.3%, 95% CI 0.5 - 2.8) treated with sertindole and one with unspecified electrocardiogram changes in the comparator cohort of 16 542 patients. This study contributes to the understanding of the occurrence of prolongation of QTc interval during clinical use of sertindole, the incidence of which was similar to that in clinical trials. Although no statistically significant difference was shown in mortality rates between sertindole and comparator cohort, the sertindole cohort was too small to rule out an association between the use of this drug and cardiovascular deaths.
atypical antipsychotics, mortality rates, post marketing surveillance, prescription-event monitoring, qtc interval prolongation, sertindole
0269-8811
120-126
Wilton, Lynda
a3317627-2c1b-4c18-bd96-831972232e05
Heeley, Emma
7ace5ee8-c06c-4cb7-960f-544a979a93c2
Pickering, Ruth
4a828314-7ddf-4f96-abed-3407017d4c90
Shakir, S.A.W.
f2948ea5-473e-4847-be2c-fc2998461b34
Wilton, Lynda
a3317627-2c1b-4c18-bd96-831972232e05
Heeley, Emma
7ace5ee8-c06c-4cb7-960f-544a979a93c2
Pickering, Ruth
4a828314-7ddf-4f96-abed-3407017d4c90
Shakir, S.A.W.
f2948ea5-473e-4847-be2c-fc2998461b34

Wilton, Lynda, Heeley, Emma, Pickering, Ruth and Shakir, S.A.W. (2001) Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine. Journal of Psychopharmacology, 15 (2), 120-126.

Record type: Article

Abstract

Sertindole (Serdolect), an atypical antipsychotic, was voluntarily suspended in the European Union in 1998 following regulatory concerns over reports of serious cardiac dysrhythmias and sudden unexpected deaths. The reported causes of death, their frequency, prolongation of the rate corrected QT interval (QTc) and cardiac dysrhythmias in patients prescribed sertindole were compared with those for patients treated with two other atypical antipsychotics. All patients in England, prescribed atypical antipsychotics by general practitioners during each drug's immediate post-marketing period, were identified using an observational cohort technique, prescription-event monitoring. Mortality rates in the sertindole cohort were compared with those in a comparator cohort using standardized mortality ratios and incidence rate ratios. Cardiovascular events were reviewed and followed up to identify cases of prolongation of QTc interval. There was no statistically significant difference in mortality rates between sertindole and the comparator cohort, although confidence intervals (CI) were wide due to small numbers in the sertindole cohort. A much smaller number of patients were prescribed sertindole than the other antipsychotics. Six cases of prolongation of QTc interval were identified in 462 patients (1.3%, 95% CI 0.5 - 2.8) treated with sertindole and one with unspecified electrocardiogram changes in the comparator cohort of 16 542 patients. This study contributes to the understanding of the occurrence of prolongation of QTc interval during clinical use of sertindole, the incidence of which was similar to that in clinical trials. Although no statistically significant difference was shown in mortality rates between sertindole and comparator cohort, the sertindole cohort was too small to rule out an association between the use of this drug and cardiovascular deaths.

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More information

Published date: 2001
Keywords: atypical antipsychotics, mortality rates, post marketing surveillance, prescription-event monitoring, qtc interval prolongation, sertindole

Identifiers

Local EPrints ID: 24558
URI: http://eprints.soton.ac.uk/id/eprint/24558
ISSN: 0269-8811
PURE UUID: 9b1b282f-9ee9-4b1c-b11e-57bb1ecc27d3

Catalogue record

Date deposited: 31 Mar 2006
Last modified: 07 Jan 2022 22:15

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Contributors

Author: Lynda Wilton
Author: Emma Heeley
Author: Ruth Pickering
Author: S.A.W. Shakir

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