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The safety and tolerability of sertindole in elderly patients with dementia
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adjustment may be necessarywhen quetiapine is to be administered with CYP3A4 inducers. Dose adjustment is not necessary when quetiap ine is coadministered with cimetidine.
E. Sertindole ~'1 SERTINDOLE'S IMPROVEMENT OF NEGATIVE SYMPTOMS, IS IT INDEPENDENT OF EXTRA-PYRAMIDAL SYMPTOMS, DEPRESSION AND POSITIVE SYMPTOMS? Nigel Bark, Nancy Moynihan, Denize Da Silva-Siegel
AECOM Schizophrenia Research Unit. Bronx Psychiatric Center. 1500 Waters Place. Bronx, New York 10461 Sertindole, a new antipsychotic discovered and patented by H. Lundb eck A/S (Copenhagen) and developed in the United States by Abbott Laboratories, has been shown in three major North American trials to significantly improve PANSS scores with placebo level extra-pyramidal symptoms. In all three studies sertindole 20 mg significantlyimproved tardive dyskinesia as did haloperidol 4 mg but not 8, or 16 mg in those studies using haloperidol. All doses of haloperidol caused significant worsening of akathisia and parkinsonism which were improved in the sertindole treated patients. In the two studies that compared sertindole with haloperidol only sertindole significantlyimproved negative symptoms with the PANSS Negative Scale, the PANSS Negative Factor (of Lindenmayer) and, in the one study using it. the SANS. The PANSS Cognitive Factor which has items from the PANSS Negative scale and accounts for some correlations with that scale (eg soft neurological signs) was improved by all doses of haloperidol and sertindole. The Depression Factor was improved by all doses of sertindole and haloperidol except 16 mg haloperidol. The extent to which improvement in negative symptoms is secondary to improvement in extra-pyramidal symptoms, depression and positive symptoms is being examined by further analyses and results will be presented and discussed. ~€>c
THE SAFETY AND TOLERABILITY OF SERTINDOLE IN ELDERLY PATIENTS WITH DEMENTIA Peter Buckley, MD, Neal Cutler, MD, Christopher Silber, MD, Jan O'Neil, Randall Mack
Dept. ofPsychiatry. Case Western Reserve University. 11100 EuclidAvenue. Cleveland. OH 44106 Sertindole is a novel atypical antipsychotic discovered and patented by H. Lundbeck (Copenhagen) and under develop-
ment by Abbott Laboratories in the United States, Latin America and Canada. Sertindole demonstrates selectiveantagonistic activity at D 2 • S-HT2 and OCI receptors with no affinity for histaminic. muscarinic or oc2 receptors. The efficacy of sertindole in psychosis, without extrapyramidal symptoms (EPS). has been attributed to its 100-fold greater selectivity for limbic D 2 receptors as compared to nigrostriatal D 2 receptors. This double-blind, placebo-controlled. single-center study, assessed the safety and tolerability of sertindole in elderly patients with dementia. Twenty patients, age 65 years or older and meeting DSM-IV criteria for dementia, were hospitalized, and randomized to receive sertindole (n-16) or placebo (n= 4). The initial dose of sertindole was 4 mg which was titrated to a maximum of 16 mg in 4 mg increments every 4 days. All patients received 16 days of study medication. Assessments of safety and tolerability included movement rating scales. adverse events. laboratory tests and ECGs. Sertindole was generally well-tolerated by these elderly patients . In this study, with a duration of 16days, all parameters indicated that sertindole produced minimal extrapyramidal side effects,corroborated by the lack of use ofanti-EPS medications.
.t'6~ REDUCfION OF HOSPITAL DAYS IN SERTINDOLE TREATED PATIENTS: ONE YEAR FINDINGS Larry Ereshefsky, PharmD, Azmi Nabulsi, MD. Christopher Silber, MD, Randall Mack
University of Texas Health SciencesCenter. 7703 Floyd Curl Drive. San Antonio. TX 78284-6220 Sertindole, a novel antipsychotic, discovered and patented by H. Lundbeck (Copenhagen) and under development in the United States. Canada and Latin America by Abbott Laboratories, has demonstrated efficacy for negative symptoms and less extrapyramidal symptoms than standard treatment . Among the most costly items in the care of schizophrenia are hospitalizations and length of stay associated with relapse. Therefore, any new therapy for schizophrenia should demonstrate cost-effectiveness by a reduction in the number and length of hospital readmissions. This retrospective analysis assessed the impact of sertindole on the number of hospital days during a one-year period. Data was derived from a Phase II. open-label, multicenter. long-term safety study of sertindole; supplemented by review of medical charts. Analysis included 35 sertindole-treated ~atients (sertindole group) and 40 'usual care' patients (comparrson ~oup), all of whom participated in the Phase II study. Hospital days for each group were calculated during the twelve months prior to the patients initiation into the double-blind period (period I) and the twelvemonths following the transition from the double-blind period to open-label (period 2). The two groups were similar for demographics. clinical characteristics and hospital days at baseline. Both groups had fewer hospital days during period 2 than period 1. However. the number of hospital days in period 2, excluding the initial
adjustment may be necessarywhen quetiapine is to be administered with CYP3A4 inducers. Dose adjustment is not necessary when quetiap ine is coadministered with cimetidine.
E. Sertindole ~'1 SERTINDOLE'S IMPROVEMENT OF NEGATIVE SYMPTOMS, IS IT INDEPENDENT OF EXTRA-PYRAMIDAL SYMPTOMS, DEPRESSION AND POSITIVE SYMPTOMS? Nigel Bark, Nancy Moynihan, Denize Da Silva-Siegel
AECOM Schizophrenia Research Unit. Bronx Psychiatric Center. 1500 Waters Place. Bronx, New York 10461 Sertindole, a new antipsychotic discovered and patented by H. Lundb eck A/S (Copenhagen) and developed in the United States by Abbott Laboratories, has been shown in three major North American trials to significantly improve PANSS scores with placebo level extra-pyramidal symptoms. In all three studies sertindole 20 mg significantlyimproved tardive dyskinesia as did haloperidol 4 mg but not 8, or 16 mg in those studies using haloperidol. All doses of haloperidol caused significant worsening of akathisia and parkinsonism which were improved in the sertindole treated patients. In the two studies that compared sertindole with haloperidol only sertindole significantlyimproved negative symptoms with the PANSS Negative Scale, the PANSS Negative Factor (of Lindenmayer) and, in the one study using it. the SANS. The PANSS Cognitive Factor which has items from the PANSS Negative scale and accounts for some correlations with that scale (eg soft neurological signs) was improved by all doses of haloperidol and sertindole. The Depression Factor was improved by all doses of sertindole and haloperidol except 16 mg haloperidol. The extent to which improvement in negative symptoms is secondary to improvement in extra-pyramidal symptoms, depression and positive symptoms is being examined by further analyses and results will be presented and discussed. ~€>c
THE SAFETY AND TOLERABILITY OF SERTINDOLE IN ELDERLY PATIENTS WITH DEMENTIA Peter Buckley, MD, Neal Cutler, MD, Christopher Silber, MD, Jan O'Neil, Randall Mack
Dept. ofPsychiatry. Case Western Reserve University. 11100 EuclidAvenue. Cleveland. OH 44106 Sertindole is a novel atypical antipsychotic discovered and patented by H. Lundbeck (Copenhagen) and under develop-
ment by Abbott Laboratories in the United States, Latin America and Canada. Sertindole demonstrates selectiveantagonistic activity at D 2 • S-HT2 and OCI receptors with no affinity for histaminic. muscarinic or oc2 receptors. The efficacy of sertindole in psychosis, without extrapyramidal symptoms (EPS). has been attributed to its 100-fold greater selectivity for limbic D 2 receptors as compared to nigrostriatal D 2 receptors. This double-blind, placebo-controlled. single-center study, assessed the safety and tolerability of sertindole in elderly patients with dementia. Twenty patients, age 65 years or older and meeting DSM-IV criteria for dementia, were hospitalized, and randomized to receive sertindole (n-16) or placebo (n= 4). The initial dose of sertindole was 4 mg which was titrated to a maximum of 16 mg in 4 mg increments every 4 days. All patients received 16 days of study medication. Assessments of safety and tolerability included movement rating scales. adverse events. laboratory tests and ECGs. Sertindole was generally well-tolerated by these elderly patients . In this study, with a duration of 16days, all parameters indicated that sertindole produced minimal extrapyramidal side effects,corroborated by the lack of use ofanti-EPS medications.
.t'6~ REDUCfION OF HOSPITAL DAYS IN SERTINDOLE TREATED PATIENTS: ONE YEAR FINDINGS Larry Ereshefsky, PharmD, Azmi Nabulsi, MD. Christopher Silber, MD, Randall Mack
University of Texas Health SciencesCenter. 7703 Floyd Curl Drive. San Antonio. TX 78284-6220 Sertindole, a novel antipsychotic, discovered and patented by H. Lundbeck (Copenhagen) and under development in the United States. Canada and Latin America by Abbott Laboratories, has demonstrated efficacy for negative symptoms and less extrapyramidal symptoms than standard treatment . Among the most costly items in the care of schizophrenia are hospitalizations and length of stay associated with relapse. Therefore, any new therapy for schizophrenia should demonstrate cost-effectiveness by a reduction in the number and length of hospital readmissions. This retrospective analysis assessed the impact of sertindole on the number of hospital days during a one-year period. Data was derived from a Phase II. open-label, multicenter. long-term safety study of sertindole; supplemented by review of medical charts. Analysis included 35 sertindole-treated ~atients (sertindole group) and 40 'usual care' patients (comparrson ~oup), all of whom participated in the Phase II study. Hospital days for each group were calculated during the twelve months prior to the patients initiation into the double-blind period (period I) and the twelvemonths following the transition from the double-blind period to open-label (period 2). The two groups were similar for demographics. clinical characteristics and hospital days at baseline. Both groups had fewer hospital days during period 2 than period 1. However. the number of hospital days in period 2, excluding the initial