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| |  ECNP: Sertindole Superior to Haloperidol for Extrapyramidal Symptoms in Schizophrenic Patients By Bruce Sylvester Special to DG News BARCELONA, SPAIN -- October 9, 2002 -- Sertindole is effective for treatment of psychosis, including negative symptoms, and is superior to haloperidol for extrapyramidal symptoms (EPS) and use of anti-EPS medication. Dr. A. Hale of H. Lundbeck A/S, in Copenhagen, Denmark, reported the findings of the largest controlled study on sertindole here October 8 at the 15th Congress of the European College of Neuropsychopharmacology (ECNP). Sertindole, an atypical, non-sedating antipsychotic, is selective for the mesolimbic dopamine neurons and possesses a high affinity for serotonin 5-HT2 receptors. The multi-center, randomised, double-blind study enrolled 617 schizophrenic patients from 91 hospitals in 11 European countries. Five hundred and ninety five patients were treated with sertindole 8, 16, 20, or 24 mg/day or haloperidol 10 mg/day for up to eight weeks. Inclusion criteria included DSM-III-R primary diagnosis of schizophrenia, two of four items of PANSS (Positive and Negative Symptoms Scale), with item scores of 0 or less to 2, and with the sum of any two items at 8 or greater. The four items were conceptual disorganisation, hallucinatory behaviour, suspiciousness, and unusual thought content. Patients were also required to have no prior neuroleptic treatment or no therapeutic response to a neuroleptic drug within the past five years, current hospitalisation, and to be between 18 and 65 years of age. At endpoint, total PANSS scores decreased significantly in all treatment groups. The greatest overall improvement was seen in the 16mg/day sertindole group. Sertindole at doses of 16 and 24 mg/day was significantly more effective than sertindole 8 mg/day and haloperidol 10 mg/day. Of the patients who completed the study, those in the sertindole 16 mg/day group had significantly lower total PANSS negative subscale scores compared to those on haloperidol. Sertindole 16mg/day showed a mean PANSS change of -23.8 versus 22.8 for haloperidol (p=0.05). All patients taking sertindole had significantly fewer EPS than those on haloperidol. Significantly greater percentage of haloperidol-treated patients used anti-EPS medication compared to sertindole-treated patients. Fifty-three percent of patients taking haloperidol reported treatment-related adverse event compared to those taking sertindole 16 mg/day. A statistically significant deterioration in Barnes Akathisia Scale (BAS) and the Simpson Angus Scale (SAS) scores was noted for haloperidol compared to sertindole. Overall, sertindole was well tolerated. "For individual EPS-related adverse events, except hypokinesia, no statistically significant differences between patients receiving 8mg/day sertindole and all other sertindole groups could be detected," Dr. Hale concluded. The research was supported by H. Lundbeck A/S, which discovered sertindole.
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