Safety and efficacy of sertindole in general clinical practice: results of the Czech naturalistic survey
Abstract
The naturalistic, 6 month follow-up study with sertindole in regular clinical practice, supported by Lundbeck Czech Republic, has been motivated by relatively little clinical experience with sertindole in the Czech Republic. The purpose of the study was to evaluate the safety and tolerance of treatment with sertindole and to assess treatment efficacy while at the same time defining the factors associated with good treatment response to sertindole in patients with schizophrenia. 330 patients of middle age and with a slight predominance of women in total were successfully included in the analysis.
Schizophrenia was diagnosed in three quarters of the patients (n = 246). In terms of safety, no serious adverse effects were reported during the study.
QTc interval extension occurred in 6 patients, thus in 1.8 % of the whole set of enrolled patients. Adverse effects were reported in 6.1 % patients.
Observed laboratory value levels remained unchanged during the follow-up; statistically significant weight reduction was found. In terms of efficacy, the therapy was terminated prematurely in 3.1 % patients due to lack of efficacy; two thirds of the patients were evaluated as responders to sertindole.
Observational naturalistic follow-up showed that treatment with sertindole is a safe and effective alternative to antipsychotic therapy in patients with schizophrenia.