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Evaluation of patients on sertindole treatment after failure of other antipsychotics: a retrospective analysis.

Azorin JM, Murteira S, Hansen K, Toumi M - BMC Psychiatry (2008)

Bottom Line: The duration of hospitalizations also decreased significantly during the periods of sertindole treatment.Results showed that patients improved in objective social parameters when switched to sertindole treatment; assessment of the patients' affective lives showed a significant increase in the number of patients having a stable relationship during sertindole treatment; and assessment of the number of patients employed showed an increase after the first and second switch to sertindole treatment (from Period 1 to Period 2 and from Period 3 to Period 4, respectively).A group of patients benefited from sertindole after other antipsychotic treatments, including that with atypical antipsychotics, had failed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, CHU Sainte Marguerite, Marseilles, France. jazorin@mail.ap-hm.fr

ABSTRACT

Background: Use of the atypical antipsychotic sertindole was suspended for four years due to safety concerns. During the suspension, the regulatory authorities required further studies, including this one, to be conducted. The purpose of this study was to determine if a subset of patients with psychotic illness exists which particularly benefits from sertindole treatment after failure of other antipsychotic drugs, including atypical antipsychotics.

Methods: This was a retrospective single-arm observational crossover study of 344 patients, who served as their own controls. Patients mainly from the Sertindole Safety Study who had shown good response to sertindole, and who had followed up to four alternating six month periods of treatment with sertindole and other antipsychotics, were included. (In Period 1 patients took non-sertindole treatment, in Period 2, sertindole was taken, in Period 3, patients reverted to non-sertindole treatment, and in Period 4, sertindole was taken again.) Patient records for each period of treatment were assessed for objective data: number and duration of hospitalizations due to worsening of psychotic symptoms; the amount of self-harming behaviour; indicators of social status. Retrospective evaluation of changes in clinical symptoms from the patients' records was also conducted. Dates and reasons for stopping and/or switching medication were also recorded.

Results: There was improvement in all objective measured parameters during the periods of sertindole treatment. In particular, the average number of hospitalizations per year due to worsening of psychotic symptoms was reduced in the following way in the group studied over four treatment periods: Period 1 (non-sertindole treatment) 3.4; Period 2 (sertindole treatment) 1.0; Period 3 (non-sertindole treatment) 2.0; Period 4 (sertindole treatment) 1.8. The duration of hospitalizations also decreased significantly during the periods of sertindole treatment. Results showed that patients improved in objective social parameters when switched to sertindole treatment; assessment of the patients' affective lives showed a significant increase in the number of patients having a stable relationship during sertindole treatment; and assessment of the number of patients employed showed an increase after the first and second switch to sertindole treatment (from Period 1 to Period 2 and from Period 3 to Period 4, respectively). Adverse events and lack of efficacy were the main reasons for switching to sertindole.

Conclusion: A group of patients benefited from sertindole after other antipsychotic treatments, including that with atypical antipsychotics, had failed. Further studies are needed to investigate if there is a specific patient profile that corresponds to these responders.

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Patients per number of periods experienced.
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Figure 2: Patients per number of periods experienced.

Mentions: From the patients included in this study, around 17% followed four treatment periods. From the remaining patients, around 45% followed three treatment periods and around 38% followed two treatment periods. The number of patients within each group is shown on Figure 2. After the first treatment with sertindole, the average treatment duration did not change significantly between periods, ranging from 8.7 ± 5.9 (SD) months in Period 2 to 6.4 ± 4.3 (SD) months in Period 4, as shown in Table 3.


Evaluation of patients on sertindole treatment after failure of other antipsychotics: a retrospective analysis.

Azorin JM, Murteira S, Hansen K, Toumi M - BMC Psychiatry (2008)

Patients per number of periods experienced.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2358897&req=5

Figure 2: Patients per number of periods experienced.
Mentions: From the patients included in this study, around 17% followed four treatment periods. From the remaining patients, around 45% followed three treatment periods and around 38% followed two treatment periods. The number of patients within each group is shown on Figure 2. After the first treatment with sertindole, the average treatment duration did not change significantly between periods, ranging from 8.7 ± 5.9 (SD) months in Period 2 to 6.4 ± 4.3 (SD) months in Period 4, as shown in Table 3.

Bottom Line: The duration of hospitalizations also decreased significantly during the periods of sertindole treatment.Results showed that patients improved in objective social parameters when switched to sertindole treatment; assessment of the patients' affective lives showed a significant increase in the number of patients having a stable relationship during sertindole treatment; and assessment of the number of patients employed showed an increase after the first and second switch to sertindole treatment (from Period 1 to Period 2 and from Period 3 to Period 4, respectively).A group of patients benefited from sertindole after other antipsychotic treatments, including that with atypical antipsychotics, had failed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, CHU Sainte Marguerite, Marseilles, France. jazorin@mail.ap-hm.fr

ABSTRACT

Background: Use of the atypical antipsychotic sertindole was suspended for four years due to safety concerns. During the suspension, the regulatory authorities required further studies, including this one, to be conducted. The purpose of this study was to determine if a subset of patients with psychotic illness exists which particularly benefits from sertindole treatment after failure of other antipsychotic drugs, including atypical antipsychotics.

Methods: This was a retrospective single-arm observational crossover study of 344 patients, who served as their own controls. Patients mainly from the Sertindole Safety Study who had shown good response to sertindole, and who had followed up to four alternating six month periods of treatment with sertindole and other antipsychotics, were included. (In Period 1 patients took non-sertindole treatment, in Period 2, sertindole was taken, in Period 3, patients reverted to non-sertindole treatment, and in Period 4, sertindole was taken again.) Patient records for each period of treatment were assessed for objective data: number and duration of hospitalizations due to worsening of psychotic symptoms; the amount of self-harming behaviour; indicators of social status. Retrospective evaluation of changes in clinical symptoms from the patients' records was also conducted. Dates and reasons for stopping and/or switching medication were also recorded.

Results: There was improvement in all objective measured parameters during the periods of sertindole treatment. In particular, the average number of hospitalizations per year due to worsening of psychotic symptoms was reduced in the following way in the group studied over four treatment periods: Period 1 (non-sertindole treatment) 3.4; Period 2 (sertindole treatment) 1.0; Period 3 (non-sertindole treatment) 2.0; Period 4 (sertindole treatment) 1.8. The duration of hospitalizations also decreased significantly during the periods of sertindole treatment. Results showed that patients improved in objective social parameters when switched to sertindole treatment; assessment of the patients' affective lives showed a significant increase in the number of patients having a stable relationship during sertindole treatment; and assessment of the number of patients employed showed an increase after the first and second switch to sertindole treatment (from Period 1 to Period 2 and from Period 3 to Period 4, respectively). Adverse events and lack of efficacy were the main reasons for switching to sertindole.

Conclusion: A group of patients benefited from sertindole after other antipsychotic treatments, including that with atypical antipsychotics, had failed. Further studies are needed to investigate if there is a specific patient profile that corresponds to these responders.

Show MeSH
Related in: MedlinePlus