Sertindole is a novel atypical
antipsychotic, which has shown efficacy in the treatment of positive and negative symptoms of
schizophrenia in phase II and III studies. Furthermore, these studies have demonstrated tolerability and a favourable side-effect profile. In contrast to classical
antipsychotics,
sertindole was not associated with extrapyramidal symptoms (EPS). We report
drug surveillance data in 34 comorbid and comedicated
sertindole treated patients suffering from different
psychotic disorders. The
drug surveillance consisted of two distinct phases: inpatient treatment and outpatient follow-up. Clinical global impression (severity and improvement of illness), psychotic symptoms, side-effects, and blood parameters have been carefully documented. With special respect to cardiac safety electrocardiograms (ECGs) have been recorded twice (during
sertindole treatment and during treatment with an
antipsychotic different from
sertindole). Recommended ECG-parameters for assessment of the proarrhythmic risk of a
drug have been calculated (QTc-, QTc2-interval; QT-, QTc-dispersion). The majority of patients (n = 29) have been treated previously with several typical and/or atypical
antipsychotics. We observed a clinical response to
sertindole treatment in 29 patients (85%). Both positive and negative symptoms improved with
sertindole and no severe side-effects have been documented. EPS occurred at placebo level. A mean QTc-interval prolongation of 19.7 ms (4.7%) has been detected. None of the patients developed clinical or electrocardiographic evidence of
cardiac dysrhythmia during
sertindole treatment, or other clinical evidence of cardiac abnormalities. In summary,
sertindole did show efficacy for positive and negative symptoms together with a favourable side-effect profile. No evidence for an increased proarrhythmic risk has been found.