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The atypical antipsychotic sertindole: A case series
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57'S THE ATYPICAL ANTIPSYCHOTIC SERTINDOLE: A CASE SERIES Trisha Suppes, MD, PhD. Ava Lee, MD, Betty Paul, Broc Sanchez, Randall Mack Saint Paul Procesional Bldg.• 5959 Harry Hines Blvd., Su ite 600. Dallas, TX 75235
Sertindole, discovered and patented by H. Lundbeck (Copenhagen) and under development in the United States, Can ada and Latin America by Abbott Laboratories , is a novel ant ipsychotic for the treatment of the manifestations of psychosis. Psychotic disorders are often difficult to treat with traditional neuroleptics. Sertindole is a new atypical neuroleptic with a broader brain receptor profile. Ten patients diagnosed with either schizophrenia or schizoaffective disorder were entered into a FDA Phase III medical safety study. Patients were treated with sertindole for 18 months and observed for changes in Clinical Global Impression Scale scores. Nine patients experienced a reduction of symptoms after 12 months of treatment. Eight patients completed 18 months of treatment, all exhibiting overall improvement. Despite side effects of tiredness, weight gain, headache, nausea, and decreased ejaculatory volume, sertindole was generally well tolerated. Sertindole appears to be useful treatment in psychotic disorder. It represents an advantage over traditional neuroleptics because the sertindole side effect profile displays fewer extrapyramidal symptoms, less exacerbation of positive symptoms, and improvement in negative symptoms.
parallel design, study (M93-132), was to assess the long-term (one year) efficacy and safety of sertindole (24 mg once daily) compared to haloperidol (10 mg once daily) in schizophrenic out-patients who had been stable on a neuroleptic agent (excluding clozapine) for at least three months. Secondary objectives included measurements of negative symptoms, quality of life and resource utilization for each group. Efficacy assessments included BPRS, PANSS, SANS, SDS and CGI. Assessments of extrapyramidal symptoms (EPS) were made using movement rating scales, incidence of EPSrelated adverse events and use ofanti-EPS medications. Adverse events, laboratory tests and ECGs were utilized to assess safety; and quality of life scale and a resource utilization questionnaire were used to assess secondary objectives. Interim blinded data on 204 patients with up to six months of treatment showed the greatest mean improvement from baseline to Total PANSS to take place at the second month. Improvement remained relatively stable through month six.
~7S COMPARING SERTINDOLE CLINICAL DATA AND PATIENTS ACROSS THE OCEANS Allan Wehnert, Michael van der Burght, and Mogens Sloth-Nielsen H. Lundbeck A/S. Ottiliavej 9, DK-2500 Copenhagen-Va/by. Denmark
$"'74 A MULTI-CENTER, ONE YEAR, HALOPERIDOL CONTROLLED TRIAL ASSESSING THE LONG TERM SAFETY, EFFICACY AND QUALITY OF LIFE OF SERTINDOLE IN STABLE SCHIZOPHRENIC PATIENTS Alan Swann, MD, Kathy Holgate, Jerry Staser, Christopher Silber, MD, Randall Mack The Univ. ofTexas Mental Science Inst.. 1300 Moursund Avenue. Houston , TX 77030
Discovered and patented by H. Lundbeck (Copenhagen) and under development by Abbott Laboratories in the United States. Latin America and Canada, sertindole is a novel antipsychot ic with nanomolar affinities for dopamine D 2, serotonin 5-HT 2 and OCt adrenergic receptors. Demonstrating a 100-fold greater selectivityfor dopamine neurons within the limbic area over the nigrostriatal area, sertindole has been hypothesized to effectively treat psychotic symptoms without causing unwanted extrapyramidal side effects. The primary objective of the multicenter, double-blind,
Sertindole, discovered and patented by H. Lundbeck A/S (Copenhagen, Denmark) and co-developed with Abbott Laboratories (Chicago, USA), is a novel antipsychotic for the treatment of psychotic disorders. Sertindole was studied in three comprehensive phase III studies in schizophrenic patients during the period from 1993 to 1996. Two large studies were undertaken in the USA (M93-113, N =497 and M93-098, N =462) and one European multinational study comprising 11 countries (93302, N=617). One fundamental problem in conducting multinational studies in schizophrenia has been cultural differences in treatment practice between countries, continents as well as within each country. Another problem has been differencein diagnostic criteria between Europe and USA. Despite these differences we have shown with the development of sertindole that it is possible to have conclusive and comparable results across the oceans. All 3 studies showed independently that sertindole is effective in the treatment of positive and negative symptoms of schizophrenia and that sertindole has a favourable safety profile with EPS comparable to that of placebo. These 3 studies also suggests that studies of schizophrenic patients in Europe are largely comparable to US studies if careful considerations are taken with respect to study population and study coordination.
57'S THE ATYPICAL ANTIPSYCHOTIC SERTINDOLE: A CASE SERIES Trisha Suppes, MD, PhD. Ava Lee, MD, Betty Paul, Broc Sanchez, Randall Mack Saint Paul Procesional Bldg.• 5959 Harry Hines Blvd., Su ite 600. Dallas, TX 75235
Sertindole, discovered and patented by H. Lundbeck (Copenhagen) and under development in the United States, Can ada and Latin America by Abbott Laboratories , is a novel ant ipsychotic for the treatment of the manifestations of psychosis. Psychotic disorders are often difficult to treat with traditional neuroleptics. Sertindole is a new atypical neuroleptic with a broader brain receptor profile. Ten patients diagnosed with either schizophrenia or schizoaffective disorder were entered into a FDA Phase III medical safety study. Patients were treated with sertindole for 18 months and observed for changes in Clinical Global Impression Scale scores. Nine patients experienced a reduction of symptoms after 12 months of treatment. Eight patients completed 18 months of treatment, all exhibiting overall improvement. Despite side effects of tiredness, weight gain, headache, nausea, and decreased ejaculatory volume, sertindole was generally well tolerated. Sertindole appears to be useful treatment in psychotic disorder. It represents an advantage over traditional neuroleptics because the sertindole side effect profile displays fewer extrapyramidal symptoms, less exacerbation of positive symptoms, and improvement in negative symptoms.
parallel design, study (M93-132), was to assess the long-term (one year) efficacy and safety of sertindole (24 mg once daily) compared to haloperidol (10 mg once daily) in schizophrenic out-patients who had been stable on a neuroleptic agent (excluding clozapine) for at least three months. Secondary objectives included measurements of negative symptoms, quality of life and resource utilization for each group. Efficacy assessments included BPRS, PANSS, SANS, SDS and CGI. Assessments of extrapyramidal symptoms (EPS) were made using movement rating scales, incidence of EPSrelated adverse events and use ofanti-EPS medications. Adverse events, laboratory tests and ECGs were utilized to assess safety; and quality of life scale and a resource utilization questionnaire were used to assess secondary objectives. Interim blinded data on 204 patients with up to six months of treatment showed the greatest mean improvement from baseline to Total PANSS to take place at the second month. Improvement remained relatively stable through month six.
~7S COMPARING SERTINDOLE CLINICAL DATA AND PATIENTS ACROSS THE OCEANS Allan Wehnert, Michael van der Burght, and Mogens Sloth-Nielsen H. Lundbeck A/S. Ottiliavej 9, DK-2500 Copenhagen-Va/by. Denmark
$"'74 A MULTI-CENTER, ONE YEAR, HALOPERIDOL CONTROLLED TRIAL ASSESSING THE LONG TERM SAFETY, EFFICACY AND QUALITY OF LIFE OF SERTINDOLE IN STABLE SCHIZOPHRENIC PATIENTS Alan Swann, MD, Kathy Holgate, Jerry Staser, Christopher Silber, MD, Randall Mack The Univ. ofTexas Mental Science Inst.. 1300 Moursund Avenue. Houston , TX 77030
Discovered and patented by H. Lundbeck (Copenhagen) and under development by Abbott Laboratories in the United States. Latin America and Canada, sertindole is a novel antipsychot ic with nanomolar affinities for dopamine D 2, serotonin 5-HT 2 and OCt adrenergic receptors. Demonstrating a 100-fold greater selectivityfor dopamine neurons within the limbic area over the nigrostriatal area, sertindole has been hypothesized to effectively treat psychotic symptoms without causing unwanted extrapyramidal side effects. The primary objective of the multicenter, double-blind,
Sertindole, discovered and patented by H. Lundbeck A/S (Copenhagen, Denmark) and co-developed with Abbott Laboratories (Chicago, USA), is a novel antipsychotic for the treatment of psychotic disorders. Sertindole was studied in three comprehensive phase III studies in schizophrenic patients during the period from 1993 to 1996. Two large studies were undertaken in the USA (M93-113, N =497 and M93-098, N =462) and one European multinational study comprising 11 countries (93302, N=617). One fundamental problem in conducting multinational studies in schizophrenia has been cultural differences in treatment practice between countries, continents as well as within each country. Another problem has been differencein diagnostic criteria between Europe and USA. Despite these differences we have shown with the development of sertindole that it is possible to have conclusive and comparable results across the oceans. All 3 studies showed independently that sertindole is effective in the treatment of positive and negative symptoms of schizophrenia and that sertindole has a favourable safety profile with EPS comparable to that of placebo. These 3 studies also suggests that studies of schizophrenic patients in Europe are largely comparable to US studies if careful considerations are taken with respect to study population and study coordination.