Efficacy, cardiac safety and tolerability of sertindole: a drug surveillance

Sertindole is a novel atypical antipsychotic, which has shown efficacy in t he 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 antipsychot ics, sertindole was not associated with extrapyramidal symptoms (EPS). We r eport drug surveillance data in 34 comorbid and comedicated sertindole trea ted patients suffering from different psychotic disorders. The drug surveil lance 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 carefull y documented. With special respect to cardiac safety electrocardiograms (EC Gs) have been recorded twice (during sertindole treatment and during treatm ent with an antipsychotic different from sertindole). Recommended EGG-param eters for assessment of the proarrhythmic risk of a drug have been calculat ed (QTc-, QTc(2)-interval; QT-, QTc-dispersion). The majority of patients ( n = 29) have been treated previously with several typical and/or atypical a ntipsychotics. We observed a clinical response to sertindole treatment in 2 9 patients (85%). Both positive and negative symptoms improved with sertind ole and no severe side-effects have been documented. EPS occurred at placeb o level. A mean QTc-interval prolongation of 19.7 ms (4.7%) has been detect ed. None of the patients developed clinical or electrocardiographic evidenc e of cardiac dysrhythmia during sertindole treatment, or other clinical evi dence of cardiac abnormalities. In summary, sertindole did show efficacy fo r positive and negative symptoms together with a favourable side-effect pro file. No evidence for an increased proarrhythmic risk has been found. Int C lin Psychopharmacol 15:207-214 (C) 2000 Lippincott Williams & Wilkins.