The Sertindole Safety Survey: A Study on Patient Use in Europe
Author Information
Author(s): Lançon Christophe, Toumi Mondher, Sapin Christophe, Hansen Karina
Primary Institution: Département de Psychiatrie, CHU Sainte Marguerite, Marseilles, France
Hypothesis
What are the safety and efficacy outcomes of sertindole treatment in patients under a named patient use programme in Europe?
Conclusion
Sertindole was prescribed to a significant number of patients, indicating its necessity in specific cases despite administrative constraints.
Supporting Evidence
- 1,432 patients were included in the study.
- 97 serious adverse events were recorded, including ten fatal outcomes.
- The all-cause mortality rate was 0.51 per 100 Person-Years of Exposure.
Takeaway
Doctors gave a medicine called sertindole to many patients who didn't get better with other treatments, and it helped some of them.
Methodology
A multicenter retrospective survey of patients treated with sertindole in eleven European countries.
Potential Biases
Potential bias due to the administrative restrictions of the named patient use programme.
Limitations
The study was limited by the fact that not all records of patients treated with sertindole were studied.
Participant Demographics
The average age was 43.6 years for females and 37.3 years for males, with 44.8% male participants.
Statistical Information
Confidence Interval
[0.23–0.97]
Digital Object Identifier (DOI)
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