- Email: [email protected]
41 – Early onset of antipsychotic action in schizophrenia: A clinical marker discriminating active drug from placebo
50
ABSTRACTS / Schizophrenia Research 98 (2008) 3–199
generates not only short-term effect on subjectively perceived quality of life but also long-term effect on the treatment period as a whole. Conclusions: These data show that combination of a low dose aripiprazole and whole-body cold therapy for the treatment of schizophrenia in breast cancer patients may result in enhance antipsychotic efficacy while reducing adverse effects including hyperprolactinaemia.
41 – EARLY ONSET OF ANTIPSYCHOTIC ACTION IN SCHIZOPHRENIA: A CLINICAL MARKER DISCRIMINATING ACTIVE DRUG FROM PLACEBO T. Treuer 1, B.J. Kinon 2, L. Chen 2, J. Lambert 2, H. Ascher-Svanum 2, V. Stauffer 2, S. Kollack-Walker 2. 1
doi:10.1016/j.schres.2007.12.106
Eli Lilly, Budapest, Hungary Eli Lilly, Indianapolis IN, USA
2
Presenting Author details: [email protected] Madach Imre Street 13–14, H-1075 Budapest, Hungary, Tel.: +36 1 3285127; fax: +36 1 3285103. 40 – DEVELOPING COST-EFFECTIVE FORMULARIES: IMPLICATIONS FOR NEW ATYPICAL ANTIPSYCHOTICS K. Trakas 1, J. Diels 2, D. Nicholl 3, G. Nuyts 3. 1
Health Economics, Janssen-Ortho, Toronto, Canada Health Economics, Johnson and Johnson Pharmaceutical Services, Beerse, Belgium 3 Health Economics, Johnson and Johnson Pharmaceutical Services, Raritan, USA 2
Presenting Author details: [email protected] 19 Green Belt Drive, N131, M3C 1L9 Toronto, Canada, Tel.: +1 416 3825946; fax: +1 416 4492658.
Background: For newly available compounds, modeling techniques can help inform formulary decision-making and improve current planning in advance of extensive real-world data. Objectives: Investigate the impact of paliperidone extended-release tablets (paliperidone ER), a newly available oral antipsychotic agent, on a healthcare formulary from a payer's perspective using a hybrid costeffectiveness/budget impact approach. Methods: An atypical oral antipsychotic formulary containing risperidone, olanzapine, aripiprazole, quetiapine and ziprasidone was compared with the addition of paliperidone ER. Total medical costs and re-hospitalization stays in the year following initiation of treatment in patients diagnosed with schizophrenia (ICD-9-CM code) from Pharmetrics, a US outpatient insurance claims database with regionally representative coverage, between Jan 02 and Mar 05. Marketshare was based on IMS Health NDTI MAT ending June 2006. Paliperidone ER was assumed to attain 10% utilization, comparable to latest market entrant. Treatment effect was quantified by adjusting observed values for each atypical for potential confounders using generalized gamma regression (GLM). The adjusted outcomes of risperidone and olanzapine were used to simulate the costs and effects of paliperidone ER. Sensitivity analyses were performed on key assumptions and nonparametric bootstrapping was applied to observed data. Results: An estimated $121 per patient in total annual medical cost savings (95% CI: 35.11–206.27) could be achieved with the addition of paliperidone ER to the formulary. Assuming a hypothetical cohort of 10,000 patients, this translates into yearly savings of $1.2 million. Conclusions: The addition of a new agent with similar efficacy and tolerability profile as paliperidone ER, may lead to a more costeffective formulary. doi:10.1016/j.schres.2007.12.107
Background: Research shows early non-response is a robust predictor of subsequent non-response to antipsychotics in schizophrenia treatment. Objectives were to determine if: (a) early non-response is predictive of subsequent non-response in placebo treatment, (b) early non-response discriminates placebo from active drug (AD), and (c) difference observed early in treatment is sustainable at subsequent time points. Methods: Post-hoc, pooled analysis of 2 randomized trials compared 170 patients treated with placebo or low dose olanzapine (1 mg/day) to 252 patients treated with haloperidol (10–20 mg/day) or olanzapine (7.5–17.5 mg/day, AD). Psychopathology assessed using Brief Psychiatric Rating Scale (BPRS). Early improvement (2 weeks) defined as ≥25% reduction in BPRS total score; subsequent response (6 weeks), ≥40% improvement. Group differences tested using Mixed Model Repeated Measure (MMRM). Receiver operating characteristics including area under the curve (AUC), sensitivity, specificity, and predictive values determined. Results: Based on 25% BPRS total score improvement (2 weeks), 71% of PBO patients were early non-responders, 48% of AD patients met criterion of early non-response. Early non-response was predictive of subsequent non-response: PBO (negative predictive value, NPV = 95%); AD (NPV= 84%). AUC was optimal at 2 weeks, indicating the 2-week time point was adequate for predicting subsequent response. Reduction in BPRS total score (2 weeks) significantly greater for AD (LS mea n = 25.5%) versus PBO (LS mea n = 10.3%). Significant between-group difference observed at every subsequent timepoint up to 6 weeks. Early responders approximately twice as likely as early non-responders to be on AD (OR = 1.9, CI: 1.2–3.0, p = 0.01). Conclusions: Early non-response was predictive of subsequent nonresponse in schizophrenia patients receiving either treatment. Early response/non-response (2 weeks) discriminated PBO from AD; early differences in symptom improvement sustained over 6 weeks. Early response/non-response may serve as a clinical marker of subsequent clinical improvement. doi:10.1016/j.schres.2007.12.108
42 – NUMBER NEEDED TO TREAT (NNT) FOR ALL-CAUSE MEDICATION DISCONTINUATION FROM RANDOMIZED CONTROLLED TRIALS COMPARING OLANZAPINE TO OTHER ANTIPSYCHOTICS FOR THE TREATMENT OF SCHIZOPHRENIA T. Treuer 1, V. Stauffer 2, J. Karagianis 2, V. Sutton 2, H. Ascher-Svanum 2, M. Silva De Lima 2, V. Poole-Hoffmann 2, M. Tohen 2.
ABSTRACTS / Schizophrenia Research 98 (2008) 3–199
generates not only short-term effect on subjectively perceived quality of life but also long-term effect on the treatment period as a whole. Conclusions: These data show that combination of a low dose aripiprazole and whole-body cold therapy for the treatment of schizophrenia in breast cancer patients may result in enhance antipsychotic efficacy while reducing adverse effects including hyperprolactinaemia.
41 – EARLY ONSET OF ANTIPSYCHOTIC ACTION IN SCHIZOPHRENIA: A CLINICAL MARKER DISCRIMINATING ACTIVE DRUG FROM PLACEBO T. Treuer 1, B.J. Kinon 2, L. Chen 2, J. Lambert 2, H. Ascher-Svanum 2, V. Stauffer 2, S. Kollack-Walker 2. 1
doi:10.1016/j.schres.2007.12.106
Eli Lilly, Budapest, Hungary Eli Lilly, Indianapolis IN, USA
2
Presenting Author details: [email protected] Madach Imre Street 13–14, H-1075 Budapest, Hungary, Tel.: +36 1 3285127; fax: +36 1 3285103. 40 – DEVELOPING COST-EFFECTIVE FORMULARIES: IMPLICATIONS FOR NEW ATYPICAL ANTIPSYCHOTICS K. Trakas 1, J. Diels 2, D. Nicholl 3, G. Nuyts 3. 1
Health Economics, Janssen-Ortho, Toronto, Canada Health Economics, Johnson and Johnson Pharmaceutical Services, Beerse, Belgium 3 Health Economics, Johnson and Johnson Pharmaceutical Services, Raritan, USA 2
Presenting Author details: [email protected] 19 Green Belt Drive, N131, M3C 1L9 Toronto, Canada, Tel.: +1 416 3825946; fax: +1 416 4492658.
Background: For newly available compounds, modeling techniques can help inform formulary decision-making and improve current planning in advance of extensive real-world data. Objectives: Investigate the impact of paliperidone extended-release tablets (paliperidone ER), a newly available oral antipsychotic agent, on a healthcare formulary from a payer's perspective using a hybrid costeffectiveness/budget impact approach. Methods: An atypical oral antipsychotic formulary containing risperidone, olanzapine, aripiprazole, quetiapine and ziprasidone was compared with the addition of paliperidone ER. Total medical costs and re-hospitalization stays in the year following initiation of treatment in patients diagnosed with schizophrenia (ICD-9-CM code) from Pharmetrics, a US outpatient insurance claims database with regionally representative coverage, between Jan 02 and Mar 05. Marketshare was based on IMS Health NDTI MAT ending June 2006. Paliperidone ER was assumed to attain 10% utilization, comparable to latest market entrant. Treatment effect was quantified by adjusting observed values for each atypical for potential confounders using generalized gamma regression (GLM). The adjusted outcomes of risperidone and olanzapine were used to simulate the costs and effects of paliperidone ER. Sensitivity analyses were performed on key assumptions and nonparametric bootstrapping was applied to observed data. Results: An estimated $121 per patient in total annual medical cost savings (95% CI: 35.11–206.27) could be achieved with the addition of paliperidone ER to the formulary. Assuming a hypothetical cohort of 10,000 patients, this translates into yearly savings of $1.2 million. Conclusions: The addition of a new agent with similar efficacy and tolerability profile as paliperidone ER, may lead to a more costeffective formulary. doi:10.1016/j.schres.2007.12.107
Background: Research shows early non-response is a robust predictor of subsequent non-response to antipsychotics in schizophrenia treatment. Objectives were to determine if: (a) early non-response is predictive of subsequent non-response in placebo treatment, (b) early non-response discriminates placebo from active drug (AD), and (c) difference observed early in treatment is sustainable at subsequent time points. Methods: Post-hoc, pooled analysis of 2 randomized trials compared 170 patients treated with placebo or low dose olanzapine (1 mg/day) to 252 patients treated with haloperidol (10–20 mg/day) or olanzapine (7.5–17.5 mg/day, AD). Psychopathology assessed using Brief Psychiatric Rating Scale (BPRS). Early improvement (2 weeks) defined as ≥25% reduction in BPRS total score; subsequent response (6 weeks), ≥40% improvement. Group differences tested using Mixed Model Repeated Measure (MMRM). Receiver operating characteristics including area under the curve (AUC), sensitivity, specificity, and predictive values determined. Results: Based on 25% BPRS total score improvement (2 weeks), 71% of PBO patients were early non-responders, 48% of AD patients met criterion of early non-response. Early non-response was predictive of subsequent non-response: PBO (negative predictive value, NPV = 95%); AD (NPV= 84%). AUC was optimal at 2 weeks, indicating the 2-week time point was adequate for predicting subsequent response. Reduction in BPRS total score (2 weeks) significantly greater for AD (LS mea n = 25.5%) versus PBO (LS mea n = 10.3%). Significant between-group difference observed at every subsequent timepoint up to 6 weeks. Early responders approximately twice as likely as early non-responders to be on AD (OR = 1.9, CI: 1.2–3.0, p = 0.01). Conclusions: Early non-response was predictive of subsequent nonresponse in schizophrenia patients receiving either treatment. Early response/non-response (2 weeks) discriminated PBO from AD; early differences in symptom improvement sustained over 6 weeks. Early response/non-response may serve as a clinical marker of subsequent clinical improvement. doi:10.1016/j.schres.2007.12.108
42 – NUMBER NEEDED TO TREAT (NNT) FOR ALL-CAUSE MEDICATION DISCONTINUATION FROM RANDOMIZED CONTROLLED TRIALS COMPARING OLANZAPINE TO OTHER ANTIPSYCHOTICS FOR THE TREATMENT OF SCHIZOPHRENIA T. Treuer 1, V. Stauffer 2, J. Karagianis 2, V. Sutton 2, H. Ascher-Svanum 2, M. Silva De Lima 2, V. Poole-Hoffmann 2, M. Tohen 2.