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The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe

BACKGROUND: After sertindole's suspension, health authorities established a specific named-patient use (NPU) programme in order to supply sertindole to patients who did not respond to or did not tolerate alternative treatments. This programme provided the possibility of prospectively following...

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Autores principales: Lançon, Christophe, Toumi, Mondher, Sapin, Christophe, Hansen, Karina
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2008
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2496904/
https://www.ncbi.nlm.nih.gov/pubmed/18638382
http://dx.doi.org/10.1186/1471-244X-8-57
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author Lançon, Christophe
Toumi, Mondher
Sapin, Christophe
Hansen, Karina
author_facet Lançon, Christophe
Toumi, Mondher
Sapin, Christophe
Hansen, Karina
author_sort Lançon, Christophe
collection PubMed
description BACKGROUND: After sertindole's suspension, health authorities established a specific named-patient use (NPU) programme in order to supply sertindole to patients who did not respond to or did not tolerate alternative treatments. This programme provided the possibility of prospectively following an exhaustive cohort of patients treated with sertindole after its suspension. A survey was performed to assess sertindole's modalities of prescription, assess and document any serious adverse events (SAEs), and assess the mortality rate within the NPU cohort. METHODS: The study comprised a survey of sertindole-treated patients in eleven European countries. All patients treated with sertindole within the NPU programme were eligible for the study. RESULTS: 1,432 patients were included in the study. The reason for sertindole prescription was lack of efficacy (approximately 50%) or adverse events (approximately 20%) of other antipsychotic treatments. The mean sertindole dose was 13.4 mg daily. Lack of efficacy and adverse events were reported as reasons for sertindole discontinuation. A total of 97 SAEs were recorded, including ten fatal outcomes, which occurred during the study period or within thirty days after sertindole discontinuation. The all-cause mortality rate was 0.51 per 100 Person-Years of Exposure (95% Poisson confidence interval: 0.23–0.97). QTc prolongation was reported in 15 patients (1.05% of total patients), being a rate of 0.85 per 100 Person-Years of Exposure [95% CI: 0.48–1.41]. CONCLUSION: Although prescribing and supplying sertindole were subject to administrative constraints, a significant number of patients were treated with sertindole, thus supporting the need for sertindole in specific cases. TRIAL REGISTRATION NUMBER: Not applicable.
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spelling pubmed-24969042008-08-06 The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe Lançon, Christophe Toumi, Mondher Sapin, Christophe Hansen, Karina BMC Psychiatry Research Article BACKGROUND: After sertindole's suspension, health authorities established a specific named-patient use (NPU) programme in order to supply sertindole to patients who did not respond to or did not tolerate alternative treatments. This programme provided the possibility of prospectively following an exhaustive cohort of patients treated with sertindole after its suspension. A survey was performed to assess sertindole's modalities of prescription, assess and document any serious adverse events (SAEs), and assess the mortality rate within the NPU cohort. METHODS: The study comprised a survey of sertindole-treated patients in eleven European countries. All patients treated with sertindole within the NPU programme were eligible for the study. RESULTS: 1,432 patients were included in the study. The reason for sertindole prescription was lack of efficacy (approximately 50%) or adverse events (approximately 20%) of other antipsychotic treatments. The mean sertindole dose was 13.4 mg daily. Lack of efficacy and adverse events were reported as reasons for sertindole discontinuation. A total of 97 SAEs were recorded, including ten fatal outcomes, which occurred during the study period or within thirty days after sertindole discontinuation. The all-cause mortality rate was 0.51 per 100 Person-Years of Exposure (95% Poisson confidence interval: 0.23–0.97). QTc prolongation was reported in 15 patients (1.05% of total patients), being a rate of 0.85 per 100 Person-Years of Exposure [95% CI: 0.48–1.41]. CONCLUSION: Although prescribing and supplying sertindole were subject to administrative constraints, a significant number of patients were treated with sertindole, thus supporting the need for sertindole in specific cases. TRIAL REGISTRATION NUMBER: Not applicable. BioMed Central 2008-07-18 /pmc/articles/PMC2496904/ /pubmed/18638382 http://dx.doi.org/10.1186/1471-244X-8-57 Text en Copyright © 2008 Lançon et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Lançon, Christophe
Toumi, Mondher
Sapin, Christophe
Hansen, Karina
The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title_full The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title_fullStr The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title_full_unstemmed The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title_short The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe
title_sort sertindole safety survey: a retrospective analysis under a named patient use programme in europe
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2496904/
https://www.ncbi.nlm.nih.gov/pubmed/18638382
http://dx.doi.org/10.1186/1471-244X-8-57
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