Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder: An Extension Study

Joep Schoemaker, Let Stet, Peter Vrijland, Dieter Naber, John Panagides, Robin Emsley

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Introduction: Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated up to nearly 3 years, are presented for asenapine and olanzapine.
Methods: Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.
Results: 290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time (mean ± SD (range) 311.0±146.1 (10−653) d and 327.4±139.6 (15−631) d, respectively). Adverse event (AE) incidence was lower during extension (asenapine, 62%; olanzapine, 55%) than during core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were –37.0 for asenapine and –35.3 for olanzapine, with further change of 1.6 for asenapine and –0.8 for olanzapine at the extension study endpoint.
Conclusions: Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.
Original languageEnglish
Pages (from-to)196-203
JournalPharmacopsychiatry
Volume45
Issue number5
Publication statusPublished - 2012
Externally publishedYes

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Incidence
Asenapine
Double-Blind Method

Keywords

  • asenapine, schizoaffective disorder, schizophrenia, tolerability, olanzapine

Cite this

Schoemaker, J., Stet, L., Vrijland, P., Naber, D., Panagides, J., & Emsley, R. (2012). Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder: An Extension Study. Pharmacopsychiatry, 45(5), 196-203.
Schoemaker, Joep ; Stet, Let ; Vrijland, Peter ; Naber, Dieter ; Panagides, John ; Emsley, Robin. / Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder : An Extension Study. In: Pharmacopsychiatry. 2012 ; Vol. 45, No. 5. pp. 196-203.
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abstract = "Introduction: Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated up to nearly 3 years, are presented for asenapine and olanzapine. Methods: Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.Results: 290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time (mean ± SD (range) 311.0±146.1 (10−653) d and 327.4±139.6 (15−631) d, respectively). Adverse event (AE) incidence was lower during extension (asenapine, 62{\%}; olanzapine, 55{\%}) than during core study (78{\%}, 80{\%}). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were –37.0 for asenapine and –35.3 for olanzapine, with further change of 1.6 for asenapine and –0.8 for olanzapine at the extension study endpoint.Conclusions: Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.",
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Schoemaker, J, Stet, L, Vrijland, P, Naber, D, Panagides, J & Emsley, R 2012, 'Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder: An Extension Study', Pharmacopsychiatry, vol. 45, no. 5, pp. 196-203.

Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder : An Extension Study. / Schoemaker, Joep; Stet, Let; Vrijland, Peter; Naber, Dieter; Panagides, John; Emsley, Robin.

In: Pharmacopsychiatry, Vol. 45, No. 5, 2012, p. 196-203.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder

T2 - An Extension Study

AU - Schoemaker, Joep

AU - Stet, Let

AU - Vrijland, Peter

AU - Naber, Dieter

AU - Panagides, John

AU - Emsley, Robin

PY - 2012

Y1 - 2012

N2 - Introduction: Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated up to nearly 3 years, are presented for asenapine and olanzapine. Methods: Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.Results: 290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time (mean ± SD (range) 311.0±146.1 (10−653) d and 327.4±139.6 (15−631) d, respectively). Adverse event (AE) incidence was lower during extension (asenapine, 62%; olanzapine, 55%) than during core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were –37.0 for asenapine and –35.3 for olanzapine, with further change of 1.6 for asenapine and –0.8 for olanzapine at the extension study endpoint.Conclusions: Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.

AB - Introduction: Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated up to nearly 3 years, are presented for asenapine and olanzapine. Methods: Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.Results: 290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time (mean ± SD (range) 311.0±146.1 (10−653) d and 327.4±139.6 (15−631) d, respectively). Adverse event (AE) incidence was lower during extension (asenapine, 62%; olanzapine, 55%) than during core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were –37.0 for asenapine and –35.3 for olanzapine, with further change of 1.6 for asenapine and –0.8 for olanzapine at the extension study endpoint.Conclusions: Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.

KW - asenapine, schizoaffective disorder, schizophrenia, tolerability, olanzapine

M3 - Article

VL - 45

SP - 196

EP - 203

JO - Pharmacopsychiatry

JF - Pharmacopsychiatry

SN - 0176-3679

IS - 5

ER -