- Email: [email protected]
326 – Brazilian open-label switch study in noncompliant schizophrenic patients from oral antipsychotics to long-acting risperidone: A six-month interim analysis of a 12-month, multicentric study
ABSTRACTS / Schizophrenia Research 98 (2008) 3–199 Results: Results from the first trial indicated that women receiving 100 mcg estradiol improved significantly more than women on the placebo arm, in terms of positive, negative and general symptoms on the PANSS. Conclusions: The findings from both studies indicate that estradiol appears to be a useful adjunctive treatment for women with schizophrenia. This research was supported by The Stanley Medical Research Institute, The National Alliance for Research into Schizophrenia and Depression and The National Health and Medical Research Council of Australia.
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326 – BRAZILIAN OPEN-LABEL SWITCH STUDY IN NONCOMPLIANT SCHIZOPHRENIC PATIENTS FROM ORAL ANTIPSYCHOTICS TO LONG-ACTING RISPERIDONE: A SIX-MONTH INTERIM ANALYSIS OF A 12-MONTH, MULTICENTRIC STUDY M. Louza 1, H. Elkis 1, S.I. Rushel 2, I.R. Oliveira 3, R. Bressan 4, P.B. Abreu 5, H. Grabowski 6, J.C. Appolinario 7,8. 1
University of São Paulo Hospital Mário Kroeff 3 Federal University of Bahia 4 Federal University of São Paulo 5 Federal University of Rio Grande do Sul 6 Hospital Bom Retiro 7 Federal University of Rio de Janeiro 8 Janssen-Cilag Brazil 2
doi:10.1016/j.schres.2007.12.391
325 – COSTS AND OUTCOMES ASSOCIATED WITH ATYPICAL ANTIPSYCHOTIC TREATMENT OF ACUTE SCHIZOPHRENIA O. Leeuwenkamp 1, R.R. Morlock 2, C.C. Bell 3, A.A. Brogan 4, J.J. Mauskopf 4. 1
NV Organon, Oss, The Netherlands 2 Pfizer Inc, New York, NY, USA 3 GlaxoSmith Kline, Research Triangle Park, NC, USA 4 RTI, Research Triangle Park, NC, USA Presenting Author details: [email protected] Molenstraat 110, 5342 CC Oss, Netherlands, Tel.: +312 412 66 34 99. Background: We estimated the costs and outcomes associated with switching atypical antipsychotic treatment in schizophrenic patients. Methods: We developed a Markov model that includes 5 health states defined by Positive and Negative Syndrome Scale (PANSS) scores: acute episode, persistent negative symptoms, response state, clozapine as fourth-line therapy (following 2 unsuccessful medication switches) and death. Efficacy inputs were estimated using pooled clinical trial data across antipsychotics. Health state utility weights were determined from a published utility assessment based on the PANSS. The model accounts for adherence and discontinuation, symptom relapse and adverse events, uses the Framingham risk equation to incorporate metabolic and cardiovascular effects. Unit healthcare costs were determined from standard US sources. Key model outputs included inpatient and outpatient resource use and costs, the costs of cardiovascular and metabolic complications and relapse-associated costs. Time and cost across health states were compared between patients who initiated therapy with a first-generation atypical antipsychotic, switched as needed to a second-generation agent and in patients who did the opposite. Results: At 1 year, initiating therapy with a second-generation agent reduced acute episode time (12.0 vs. 12.4 weeks) and increased response state time (23.1 vs. 22.0 weeks). It was also associated with slightly lower annual total medical costs in the acute health state ($33,445 vs. $33,646) and total non-drug medical costs in all health states ($46,041 vs. $46,187). Conclusions: Initiating therapy with a second-generation atypical antipsychotic was associated with more time without symptoms and lower non-drug costs during the first year of treatment. doi:10.1016/j.schres.2007.12.392
Presenting Author details: [email protected] Rua Capote Valente 432/76, 05409001 São Paulo, Brazil, Tel.: +55 11 30811110; fax: +55 11 30811110. Background: To assess the effectiveness of the switching to longacting risperidone in patients with schizophrenia noncompliant with typical or atypical oral antipsychotics and to evaluate subject's perception of the medication in an interim analysis of patients that completed six-month of the trial. Methods: After a 2-week run-in period, patients with DSM-IV schizophrenia received a flexible doses regimen of long-acting risperidone (doses of 25 mg, 37.5 mg, or 50 mg were used according to clinician's judgment) every 2 weeks for 12 months. Effectiveness was assessed by the Positive and Negative Syndrome Scale (PANSS) and CGI (Clinical Global Impression). Subject's perception of the medication was measured by the Drug Attitude Inventory (DAI-10). Tolerability was assessed by adverse events report. An ITT approach using mixed-effects model was performed. Results: 39 patients were included in this analysis. Improvement was observed from week 2 through the 6-month treatment period with significant reduction in total PANSS scores (− 6.35, p b .001). CGI-S scores improved from 3.4 to 3.0 (p = .02). DAI-10 improved over the course of treatment (− 2.39, p b .001). Long-acting risperidone was well tolerated. Of the 39 patients who were included in this analysis, the most frequently reported adverse events were insomnia (10.2%), weight gain (10.2%) and acute dystonia (5.1%). Conclusions: Switching from oral antipsychotics to long-acting risperidone in noncompliant patients was associated with a significant reduction of the severity of symptoms and a better patient's attitude to treatment. Long-acting risperidone was also well-tolerated. doi:10.1016/j.schres.2007.12.393
327 – PRIOR TREATMENTS BEFORE THE USE OF CLOZAPINE: A RETROSPECTIVE CHART REVIEW A.K.P.M. Menezes 1, B.S. Avrichir 1, H. Elkis 1. 1 Department and Institute of Psychiatry – Medical School – University of São Paulo ( FMUSP)
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326 – BRAZILIAN OPEN-LABEL SWITCH STUDY IN NONCOMPLIANT SCHIZOPHRENIC PATIENTS FROM ORAL ANTIPSYCHOTICS TO LONG-ACTING RISPERIDONE: A SIX-MONTH INTERIM ANALYSIS OF A 12-MONTH, MULTICENTRIC STUDY M. Louza 1, H. Elkis 1, S.I. Rushel 2, I.R. Oliveira 3, R. Bressan 4, P.B. Abreu 5, H. Grabowski 6, J.C. Appolinario 7,8. 1
University of São Paulo Hospital Mário Kroeff 3 Federal University of Bahia 4 Federal University of São Paulo 5 Federal University of Rio Grande do Sul 6 Hospital Bom Retiro 7 Federal University of Rio de Janeiro 8 Janssen-Cilag Brazil 2
doi:10.1016/j.schres.2007.12.391
325 – COSTS AND OUTCOMES ASSOCIATED WITH ATYPICAL ANTIPSYCHOTIC TREATMENT OF ACUTE SCHIZOPHRENIA O. Leeuwenkamp 1, R.R. Morlock 2, C.C. Bell 3, A.A. Brogan 4, J.J. Mauskopf 4. 1
NV Organon, Oss, The Netherlands 2 Pfizer Inc, New York, NY, USA 3 GlaxoSmith Kline, Research Triangle Park, NC, USA 4 RTI, Research Triangle Park, NC, USA Presenting Author details: [email protected] Molenstraat 110, 5342 CC Oss, Netherlands, Tel.: +312 412 66 34 99. Background: We estimated the costs and outcomes associated with switching atypical antipsychotic treatment in schizophrenic patients. Methods: We developed a Markov model that includes 5 health states defined by Positive and Negative Syndrome Scale (PANSS) scores: acute episode, persistent negative symptoms, response state, clozapine as fourth-line therapy (following 2 unsuccessful medication switches) and death. Efficacy inputs were estimated using pooled clinical trial data across antipsychotics. Health state utility weights were determined from a published utility assessment based on the PANSS. The model accounts for adherence and discontinuation, symptom relapse and adverse events, uses the Framingham risk equation to incorporate metabolic and cardiovascular effects. Unit healthcare costs were determined from standard US sources. Key model outputs included inpatient and outpatient resource use and costs, the costs of cardiovascular and metabolic complications and relapse-associated costs. Time and cost across health states were compared between patients who initiated therapy with a first-generation atypical antipsychotic, switched as needed to a second-generation agent and in patients who did the opposite. Results: At 1 year, initiating therapy with a second-generation agent reduced acute episode time (12.0 vs. 12.4 weeks) and increased response state time (23.1 vs. 22.0 weeks). It was also associated with slightly lower annual total medical costs in the acute health state ($33,445 vs. $33,646) and total non-drug medical costs in all health states ($46,041 vs. $46,187). Conclusions: Initiating therapy with a second-generation atypical antipsychotic was associated with more time without symptoms and lower non-drug costs during the first year of treatment. doi:10.1016/j.schres.2007.12.392
Presenting Author details: [email protected] Rua Capote Valente 432/76, 05409001 São Paulo, Brazil, Tel.: +55 11 30811110; fax: +55 11 30811110. Background: To assess the effectiveness of the switching to longacting risperidone in patients with schizophrenia noncompliant with typical or atypical oral antipsychotics and to evaluate subject's perception of the medication in an interim analysis of patients that completed six-month of the trial. Methods: After a 2-week run-in period, patients with DSM-IV schizophrenia received a flexible doses regimen of long-acting risperidone (doses of 25 mg, 37.5 mg, or 50 mg were used according to clinician's judgment) every 2 weeks for 12 months. Effectiveness was assessed by the Positive and Negative Syndrome Scale (PANSS) and CGI (Clinical Global Impression). Subject's perception of the medication was measured by the Drug Attitude Inventory (DAI-10). Tolerability was assessed by adverse events report. An ITT approach using mixed-effects model was performed. Results: 39 patients were included in this analysis. Improvement was observed from week 2 through the 6-month treatment period with significant reduction in total PANSS scores (− 6.35, p b .001). CGI-S scores improved from 3.4 to 3.0 (p = .02). DAI-10 improved over the course of treatment (− 2.39, p b .001). Long-acting risperidone was well tolerated. Of the 39 patients who were included in this analysis, the most frequently reported adverse events were insomnia (10.2%), weight gain (10.2%) and acute dystonia (5.1%). Conclusions: Switching from oral antipsychotics to long-acting risperidone in noncompliant patients was associated with a significant reduction of the severity of symptoms and a better patient's attitude to treatment. Long-acting risperidone was also well-tolerated. doi:10.1016/j.schres.2007.12.393
327 – PRIOR TREATMENTS BEFORE THE USE OF CLOZAPINE: A RETROSPECTIVE CHART REVIEW A.K.P.M. Menezes 1, B.S. Avrichir 1, H. Elkis 1. 1 Department and Institute of Psychiatry – Medical School – University of São Paulo ( FMUSP)