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P.2.046 Ziprasidone versus risperidone in schizophrenia: 52 weeks' comparative data
I?2. Psychotic
disorders
and
antipsychotics
References [l] [2]
mP2
046
Ziprasidone schizophrenia: data
versus risperidone in 52 Weeks’ comparative
D. Addiugtou’, C. Pautelis2, M. Diueeu3, I. Beuattia4, S .I. Romauo4, S. Murray4. ‘Foothill Medical Centel; Psychiatry, Calgary, Canada; 2University of Melbourne, Mental Health Research Institute, Victoria, Australia; 3 University College Hospital, JT%ton, Psychiatry, Cork, Ireland; 4Pjizer Inc., n/a, New York, US.A. Purpose: To compare the efficacy aud tolerability of ziprasidoue 40-80 mg BID aud risperidoue 335 mg BID in acute exacerbation of schizophrenia or schizoaffective disorder. Methods: In au S-week, randomized, double-blind trial, primary efficacy evaluations were PANSS Total aud CGI#S scores; secondary variables included PANSS Negative Subscale score, BPRSd Total aud Core scores, aud Global Assessment of Fuuctiouiug (GAF). Primary efficacy analyses were based ou evaluable patients (~14 days of treatment). Completers could cuter a 44week, double-blind coutiuuatiou study. Results: On the basis of a predetermined equivalency criterion, evaluable ziprasidoue (11~124) aud risperidoue (ii= 132) patients demo&rated equivalent efficacy improvements in primary aud secondary measurements. Ziprasidoue had a significantly lower meau Movement Disorder Burden Score (JvIDBS) aud lower iucideuces of prolactiu elevatiou aud weight gaiu ~7%. In the 44-week coutiuuatiou, ziprasidoue (11=59) aud risperidoue (11~76) groups exhibited comparable, sustained improvement in efficacy variables from baseline of the S-week study. MDBS aud iucideuces of prolactiu elevatiou aud weight gaiu ~7% remaiued lower with ziprasidoue. Conclusion: Patients receiving 52 weeks of double-blind ziprasidoue or risperidoue demonstrated comparable symptom improvement; patients ou ziprasidoue had a lower movement disorder burden aud lower iucideuces of prolactiu elevatiou aud clinically significant weight gain References [l]
[2]
Analysis Alzheimer’s treatment
McGmth J (1999) Hypothesis: Is low prenatal vitamin D a riskmodifying factor for schizophrenia. Schizophr Res 40: 173-177. Stunpf WE, Sar M, Clark SA, DeLuca HF (1982) Brain target sites for 1,25-dihydroxyvitamin D3. Science 215: 1402-1405.
Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M, and the Ziprasidone Study Group. Zipmsidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoffective disorder: A 6-week Placebo-Controlled Trial. Neuropsychopharmacology. 1999;20(5):491&505. Simpson G, Potkin S, Weiden P, 0’ Sullivan RL, Romano S. Benefits of Ziprasidone in stable outpatients with schizophrenia switched from conventional antipsychotics, olanzapine or risperidone. Presented at the annual meeting of the American Psychiatric Association (APA); May 13-l 8, 2000; Chicago, Illinois.
s299
of motor function dementia during of psychosis with
in patients double-blind olanzapine
with
W. Deberdt’, M.M. Carrasco2, C. Jeaude13, D.P. Hay’, P.D. Feldman’, C.A. Young’ , D.L. Lehman’ , A. Breier’ , P.P. De Deyu4. ‘Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, US.A.; 2Clinica Psiquiatrica Padre Menni, Pamplona, Spain; 3CHU H6pital La Colon&i&e, Internal Medicine & Geriatric Service, Montpelliel; France; 4 University of Antwerp, Department of Neurology, Antwerpen, Belgium Introduction: Autipsychotic medication use in elderly patients has the poteutial to affect gait aud to be a risk factor for falls. Objective: To assess chauges in motor fuuctiou aud risk of falls or abnormal gait in patients with Alzheimer’ s dementia (AD) during treatment with olauzapiue. Methods: Followiug a placebo lead-in period (~14 days), 652 iupatieuts with AD aud delusions or halluciuatious were randomly assigned to oue of five treatments: placebo, or olauzapiue at fixed doses of 1.0, 2.5, 5.0, or 7.5 “g/day, for up to 10 weeks of doubleblind treatment. meau age was 76.4 years, aud 75.0% Results: Patieuts’ were female. Meau Mini-Meutal State Examiuatiou score was 13.715.1. At endpoint, patients in all five treatment groups showed slight but nonsignificant improvements from baseline ou both the Simpson-Augus scale aud Abnormal Iuvoluutary Movemeut Scale, aud iucideuce of treatment-emergent extrapyramida1 abnormalities (akathisia, akiuesia, dyskiuesia, extrapyramidal syudrome, tremor) was uot significantly differeut either among treatment groups or overall. No siguificaut chauges were seeu in Simpson-Angus Gait item scores. Modified Perfonnauce-Oriented mobility aud Mobility Assessment-II scores, indicative of patieuts’ balance, were likewise uot significantly affected. Iucideuce of falls reported as au adverse eveut was 5.3% in the 7.5~mg group, 7.9% in the 5.0~mg group, 7.4% in the 2.5~mg group, 5.4% in the 1 .Omg group, aud 5.4% in the placebo group (overall p=.863). Conclusions: Olauzapiue at doses of 1.0 to 7.5 “g/day had uo appreciable impact ou motor fuuctiou or gait, or cause auy significant iucrease in the iucideuce of falls, in elderly patients with AD. lP.2.0481
Efficacy adjunctive
of intramuscular benzodiazepines
ziprasidone
D.G. Dauiel’, S. Brook2, I. Beuattia3. ‘Bioniche Inc., n/a, McLean, US.A.; 2Stervontein Hospital, Krugersdorp, South Africa; 3Pfizer Inc., Medical, US.A.
without
Development Psychiatry, New York,
Purpose: Trials of intramuscular (IM) ziprasidoue have pennitted adjuuctive beuzodiazepiues. We analyzed IM ziprasidoue’ s efficacy in improving agitatiou aud psychopathology in subgroups of patients in two trials who did uot receive beuzodiazepiues, aud compared ziprasidoue’ s tolerability with aud without beuzodiazepiues in the second trial. Methods: The first study, a 24-hour double-blind trial, compared ziprasidoue 20 mg with ziprasidoue 2 mg in agitated psychotic iupatieuts. The second trial, rater blinded, of sequential IMoral treatment compared IM ziprasidoue (10 or 20 mg) with IM haloperidol (2.5 mg or 5 mg) for up to 3 days in patients with acute exacerbation of schizophrenia.
disorders
and
antipsychotics
References [l] [2]
mP2
046
Ziprasidone schizophrenia: data
versus risperidone in 52 Weeks’ comparative
D. Addiugtou’, C. Pautelis2, M. Diueeu3, I. Beuattia4, S .I. Romauo4, S. Murray4. ‘Foothill Medical Centel; Psychiatry, Calgary, Canada; 2University of Melbourne, Mental Health Research Institute, Victoria, Australia; 3 University College Hospital, JT%ton, Psychiatry, Cork, Ireland; 4Pjizer Inc., n/a, New York, US.A. Purpose: To compare the efficacy aud tolerability of ziprasidoue 40-80 mg BID aud risperidoue 335 mg BID in acute exacerbation of schizophrenia or schizoaffective disorder. Methods: In au S-week, randomized, double-blind trial, primary efficacy evaluations were PANSS Total aud CGI#S scores; secondary variables included PANSS Negative Subscale score, BPRSd Total aud Core scores, aud Global Assessment of Fuuctiouiug (GAF). Primary efficacy analyses were based ou evaluable patients (~14 days of treatment). Completers could cuter a 44week, double-blind coutiuuatiou study. Results: On the basis of a predetermined equivalency criterion, evaluable ziprasidoue (11~124) aud risperidoue (ii= 132) patients demo&rated equivalent efficacy improvements in primary aud secondary measurements. Ziprasidoue had a significantly lower meau Movement Disorder Burden Score (JvIDBS) aud lower iucideuces of prolactiu elevatiou aud weight gaiu ~7%. In the 44-week coutiuuatiou, ziprasidoue (11=59) aud risperidoue (11~76) groups exhibited comparable, sustained improvement in efficacy variables from baseline of the S-week study. MDBS aud iucideuces of prolactiu elevatiou aud weight gaiu ~7% remaiued lower with ziprasidoue. Conclusion: Patients receiving 52 weeks of double-blind ziprasidoue or risperidoue demonstrated comparable symptom improvement; patients ou ziprasidoue had a lower movement disorder burden aud lower iucideuces of prolactiu elevatiou aud clinically significant weight gain References [l]
[2]
Analysis Alzheimer’s treatment
McGmth J (1999) Hypothesis: Is low prenatal vitamin D a riskmodifying factor for schizophrenia. Schizophr Res 40: 173-177. Stunpf WE, Sar M, Clark SA, DeLuca HF (1982) Brain target sites for 1,25-dihydroxyvitamin D3. Science 215: 1402-1405.
Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M, and the Ziprasidone Study Group. Zipmsidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoffective disorder: A 6-week Placebo-Controlled Trial. Neuropsychopharmacology. 1999;20(5):491&505. Simpson G, Potkin S, Weiden P, 0’ Sullivan RL, Romano S. Benefits of Ziprasidone in stable outpatients with schizophrenia switched from conventional antipsychotics, olanzapine or risperidone. Presented at the annual meeting of the American Psychiatric Association (APA); May 13-l 8, 2000; Chicago, Illinois.
s299
of motor function dementia during of psychosis with
in patients double-blind olanzapine
with
W. Deberdt’, M.M. Carrasco2, C. Jeaude13, D.P. Hay’, P.D. Feldman’, C.A. Young’ , D.L. Lehman’ , A. Breier’ , P.P. De Deyu4. ‘Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, US.A.; 2Clinica Psiquiatrica Padre Menni, Pamplona, Spain; 3CHU H6pital La Colon&i&e, Internal Medicine & Geriatric Service, Montpelliel; France; 4 University of Antwerp, Department of Neurology, Antwerpen, Belgium Introduction: Autipsychotic medication use in elderly patients has the poteutial to affect gait aud to be a risk factor for falls. Objective: To assess chauges in motor fuuctiou aud risk of falls or abnormal gait in patients with Alzheimer’ s dementia (AD) during treatment with olauzapiue. Methods: Followiug a placebo lead-in period (~14 days), 652 iupatieuts with AD aud delusions or halluciuatious were randomly assigned to oue of five treatments: placebo, or olauzapiue at fixed doses of 1.0, 2.5, 5.0, or 7.5 “g/day, for up to 10 weeks of doubleblind treatment. meau age was 76.4 years, aud 75.0% Results: Patieuts’ were female. Meau Mini-Meutal State Examiuatiou score was 13.715.1. At endpoint, patients in all five treatment groups showed slight but nonsignificant improvements from baseline ou both the Simpson-Augus scale aud Abnormal Iuvoluutary Movemeut Scale, aud iucideuce of treatment-emergent extrapyramida1 abnormalities (akathisia, akiuesia, dyskiuesia, extrapyramidal syudrome, tremor) was uot significantly differeut either among treatment groups or overall. No siguificaut chauges were seeu in Simpson-Angus Gait item scores. Modified Perfonnauce-Oriented mobility aud Mobility Assessment-II scores, indicative of patieuts’ balance, were likewise uot significantly affected. Iucideuce of falls reported as au adverse eveut was 5.3% in the 7.5~mg group, 7.9% in the 5.0~mg group, 7.4% in the 2.5~mg group, 5.4% in the 1 .Omg group, aud 5.4% in the placebo group (overall p=.863). Conclusions: Olauzapiue at doses of 1.0 to 7.5 “g/day had uo appreciable impact ou motor fuuctiou or gait, or cause auy significant iucrease in the iucideuce of falls, in elderly patients with AD. lP.2.0481
Efficacy adjunctive
of intramuscular benzodiazepines
ziprasidone
D.G. Dauiel’, S. Brook2, I. Beuattia3. ‘Bioniche Inc., n/a, McLean, US.A.; 2Stervontein Hospital, Krugersdorp, South Africa; 3Pfizer Inc., Medical, US.A.
without
Development Psychiatry, New York,
Purpose: Trials of intramuscular (IM) ziprasidoue have pennitted adjuuctive beuzodiazepiues. We analyzed IM ziprasidoue’ s efficacy in improving agitatiou aud psychopathology in subgroups of patients in two trials who did uot receive beuzodiazepiues, aud compared ziprasidoue’ s tolerability with aud without beuzodiazepiues in the second trial. Methods: The first study, a 24-hour double-blind trial, compared ziprasidoue 20 mg with ziprasidoue 2 mg in agitated psychotic iupatieuts. The second trial, rater blinded, of sequential IMoral treatment compared IM ziprasidoue (10 or 20 mg) with IM haloperidol (2.5 mg or 5 mg) for up to 3 days in patients with acute exacerbation of schizophrenia.