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An integrated analysis of acute treatment-emergent extrapyramidal syndrome in patients with schizophrenia during olanzapine clinical trials: comparisons with placebo, haloperidol, risperidone, or clozapine.
J Clin Psychiatry. 2003 Aug; 64(8):898-906.JC

Abstract

BACKGROUND

The frequency and severity of extrapyramidal syndrome (EPS) were evaluated in patients with DSM-III or DSM-IV schizophrenia in the acute phase (- 8 weeks) of randomized, double-blind, controlled trials from the integrated olanzapine clinical trial database.

METHOD

This retrospective analysis included 23 clinical trials and 4611 patients from November 11, 1991, through July 31, 2001. Incidences of dystonic, parkinsonian, and akathisia events were compared using treatment-emergent adverse-event data. Categorical analyses of Simpson-Angus Scale and Barnes Akathisia Scale (BAS) scores, use of anticholinergic medications, and baseline-to-endpoint changes in Simpson-Angus Scale and BAS scores were compared.

RESULTS

A significantly smaller percentage of olanzapine-treated patients experienced dystonic events than did haloperidol- (p <.001) or risperidone-treated patients (p =.047). A significantly greater percentage of haloperidol-treated patients experienced parkinsonian (p <.001) and akathisia (p <.001) events than did olanzapine-treated patients. Categorical analysis of Simpson-Angus Scale scores showed significantly more haloperidol- (p <.001) or risperidone-treated patients (p =.004) developed parkinsonism than did olanzapine-treated patients. Olanzapine-treated patients experienced significantly greater reductions in Simpson-Angus Scale scores than did haloperidol- (p <.001), risperidone- (p <.001), or clozapine-treated (p =.032) patients. Categorical analysis of BAS scores showed significantly more haloperidol-treated patients experienced treatment-emergent akathisia versus olanzapine-treated patients (p <.001). Significantly greater reductions in BAS scores were experienced during olanzapine treatment versus placebo (p =.007), haloperidol (p <.001), and risperidone (p =.004) treatments. A significantly smaller percentage of olanzapine-treated patients received anticholinergic medications compared with that of haloperidol- (p <.001) or risperidone-treated patients (p =.018). Compared with that in olanzapine-treated patients, the duration of anticholinergic cotreatment was significantly longer among haloperidol- (p <.001) or risperidone-treated patients (p =.040) and significantly shorter among clozapine-treated patients (p =.021).

CONCLUSION

This analysis of available data from olanzapine clinical trials lends additional support to olanzapine's favorable EPS profile.

Authors+Show Affiliations

Eli Lilly and Company, Indianapolis, Ind., USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12927004

Citation

Carlson, Christopher D., et al. "An Integrated Analysis of Acute Treatment-emergent Extrapyramidal Syndrome in Patients With Schizophrenia During Olanzapine Clinical Trials: Comparisons With Placebo, Haloperidol, Risperidone, or Clozapine." The Journal of Clinical Psychiatry, vol. 64, no. 8, 2003, pp. 898-906.
Carlson CD, Cavazzoni PA, Berg PH, et al. An integrated analysis of acute treatment-emergent extrapyramidal syndrome in patients with schizophrenia during olanzapine clinical trials: comparisons with placebo, haloperidol, risperidone, or clozapine. J Clin Psychiatry. 2003;64(8):898-906.
Carlson, C. D., Cavazzoni, P. A., Berg, P. H., Wei, H., Beasley, C. M., & Kane, J. M. (2003). An integrated analysis of acute treatment-emergent extrapyramidal syndrome in patients with schizophrenia during olanzapine clinical trials: comparisons with placebo, haloperidol, risperidone, or clozapine. The Journal of Clinical Psychiatry, 64(8), 898-906.
Carlson CD, et al. An Integrated Analysis of Acute Treatment-emergent Extrapyramidal Syndrome in Patients With Schizophrenia During Olanzapine Clinical Trials: Comparisons With Placebo, Haloperidol, Risperidone, or Clozapine. J Clin Psychiatry. 2003;64(8):898-906. PubMed PMID: 12927004.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An integrated analysis of acute treatment-emergent extrapyramidal syndrome in patients with schizophrenia during olanzapine clinical trials: comparisons with placebo, haloperidol, risperidone, or clozapine. AU - Carlson,Christopher D, AU - Cavazzoni,Patrizia A, AU - Berg,Paul H, AU - Wei,Hank, AU - Beasley,Charles M, AU - Kane,John M, PY - 2003/8/21/pubmed PY - 2003/9/26/medline PY - 2003/8/21/entrez SP - 898 EP - 906 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 64 IS - 8 N2 - BACKGROUND: The frequency and severity of extrapyramidal syndrome (EPS) were evaluated in patients with DSM-III or DSM-IV schizophrenia in the acute phase (- 8 weeks) of randomized, double-blind, controlled trials from the integrated olanzapine clinical trial database. METHOD: This retrospective analysis included 23 clinical trials and 4611 patients from November 11, 1991, through July 31, 2001. Incidences of dystonic, parkinsonian, and akathisia events were compared using treatment-emergent adverse-event data. Categorical analyses of Simpson-Angus Scale and Barnes Akathisia Scale (BAS) scores, use of anticholinergic medications, and baseline-to-endpoint changes in Simpson-Angus Scale and BAS scores were compared. RESULTS: A significantly smaller percentage of olanzapine-treated patients experienced dystonic events than did haloperidol- (p <.001) or risperidone-treated patients (p =.047). A significantly greater percentage of haloperidol-treated patients experienced parkinsonian (p <.001) and akathisia (p <.001) events than did olanzapine-treated patients. Categorical analysis of Simpson-Angus Scale scores showed significantly more haloperidol- (p <.001) or risperidone-treated patients (p =.004) developed parkinsonism than did olanzapine-treated patients. Olanzapine-treated patients experienced significantly greater reductions in Simpson-Angus Scale scores than did haloperidol- (p <.001), risperidone- (p <.001), or clozapine-treated (p =.032) patients. Categorical analysis of BAS scores showed significantly more haloperidol-treated patients experienced treatment-emergent akathisia versus olanzapine-treated patients (p <.001). Significantly greater reductions in BAS scores were experienced during olanzapine treatment versus placebo (p =.007), haloperidol (p <.001), and risperidone (p =.004) treatments. A significantly smaller percentage of olanzapine-treated patients received anticholinergic medications compared with that of haloperidol- (p <.001) or risperidone-treated patients (p =.018). Compared with that in olanzapine-treated patients, the duration of anticholinergic cotreatment was significantly longer among haloperidol- (p <.001) or risperidone-treated patients (p =.040) and significantly shorter among clozapine-treated patients (p =.021). CONCLUSION: This analysis of available data from olanzapine clinical trials lends additional support to olanzapine's favorable EPS profile. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/12927004/An_integrated_analysis_of_acute_treatment_emergent_extrapyramidal_syndrome_in_patients_with_schizophrenia_during_olanzapine_clinical_trials:_comparisons_with_placebo_haloperidol_risperidone_or_clozapine_ L2 - http://www.psychiatrist.com/jcp/article/pages/2003/v64n08/v64n0807.aspx DB - PRIME DP - Unbound Medicine ER -