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Olanzapine vs haloperidol in geriatric schizophrenia: analysis of data from a double-blind controlled trial.
Int J Geriatr Psychiatry. 2003 Nov; 18(11):1013-20.IJ

Abstract

OBJECTIVES

To compare the six-week clinical response and safety profile of schizophrenia patients, age > or =60 years, receiving olanzapine (OLZ) vs haloperidol (HAL) in a double blind, randomized trial.

METHODS

Double-blind data on patients age > or =60 randomized to 5 mg/d OLZ (n=83) or 5 mg/d HAL (n=34) (Week 1) then flexibly dosed to 5-20 mg/d over six weeks, with a 48-week extension for responders, were analyzed post-hoc. Efficacy indices included the PANSS Total and PANSS Psychosis Core Total (PPCT). Safety measures included the Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), Abnormal Involuntary Movement Scale (AIMS), treatment-emergent adverse events, and laboratory values. Mixed model, repeated measures (MMRM) analyses were applied to all continuous data measured at each visit. Continuous data recorded only at phase completion or termination were analyzed with a fixed effect last observation carried forward (LOCF) model. Frequencies of categorical response data were analyzed using Fisher's exact methods. Differences were tested for significance at Week 6 using a two-sided alpha value of 0.05.

RESULTS

HAL group (n=34; age range 60-80) received a mean modal dose 9.4 mg/d while OLZ group (n=83; age range 60-86) received a mean modal dose 11.9 mg/d. At Week 6, OLZ was superior to HAL on both the PANSS Total (p=0.015) and PPCT (p=0.043). Considering safety, OLZ was superior to HAL for the SAS and BAS (p<0.001; p<0.001). No spontaneous adverse event occurred more frequently with OLZ than with HAL. In patients never receiving adjunct anticholinergic therapy, no significant differences were present for anticholinergic-like side effects including blurred vision, dry mouth, constipation, or urinary difficulties.

CONCLUSIONS

In elderly schizophrenia patients, olanzapine was more efficacious and better tolerated for extrapyramidal signs than was haloperidol. Olanzapine was equivalent to haloperidol for anticholinergic-like side effects when corrected for anticholingergic agents.

Authors+Show Affiliations

Indiana University School of Medicine, Department of Psychiatry, Indianapolis, Indiana, USA. johkenne@lupui.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

14618553

Citation

Kennedy, J S., et al. "Olanzapine Vs Haloperidol in Geriatric Schizophrenia: Analysis of Data From a Double-blind Controlled Trial." International Journal of Geriatric Psychiatry, vol. 18, no. 11, 2003, pp. 1013-20.
Kennedy JS, Jeste D, Kaiser CJ, et al. Olanzapine vs haloperidol in geriatric schizophrenia: analysis of data from a double-blind controlled trial. Int J Geriatr Psychiatry. 2003;18(11):1013-20.
Kennedy, J. S., Jeste, D., Kaiser, C. J., Golshan, S., Maguire, G. A., Tollefson, G., Sanger, T., Bymaster, F. P., Kinon, B. J., Dossenbach, M., Gilmore, J. A., & Breier, A. (2003). Olanzapine vs haloperidol in geriatric schizophrenia: analysis of data from a double-blind controlled trial. International Journal of Geriatric Psychiatry, 18(11), 1013-20.
Kennedy JS, et al. Olanzapine Vs Haloperidol in Geriatric Schizophrenia: Analysis of Data From a Double-blind Controlled Trial. Int J Geriatr Psychiatry. 2003;18(11):1013-20. PubMed PMID: 14618553.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Olanzapine vs haloperidol in geriatric schizophrenia: analysis of data from a double-blind controlled trial. AU - Kennedy,J S, AU - Jeste,D, AU - Kaiser,C J, AU - Golshan,S, AU - Maguire,G A, AU - Tollefson,G, AU - Sanger,T, AU - Bymaster,F P, AU - Kinon,B J, AU - Dossenbach,M, AU - Gilmore,J A, AU - Breier,A, PY - 2003/11/18/pubmed PY - 2004/2/11/medline PY - 2003/11/18/entrez SP - 1013 EP - 20 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 18 IS - 11 N2 - OBJECTIVES: To compare the six-week clinical response and safety profile of schizophrenia patients, age > or =60 years, receiving olanzapine (OLZ) vs haloperidol (HAL) in a double blind, randomized trial. METHODS: Double-blind data on patients age > or =60 randomized to 5 mg/d OLZ (n=83) or 5 mg/d HAL (n=34) (Week 1) then flexibly dosed to 5-20 mg/d over six weeks, with a 48-week extension for responders, were analyzed post-hoc. Efficacy indices included the PANSS Total and PANSS Psychosis Core Total (PPCT). Safety measures included the Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), Abnormal Involuntary Movement Scale (AIMS), treatment-emergent adverse events, and laboratory values. Mixed model, repeated measures (MMRM) analyses were applied to all continuous data measured at each visit. Continuous data recorded only at phase completion or termination were analyzed with a fixed effect last observation carried forward (LOCF) model. Frequencies of categorical response data were analyzed using Fisher's exact methods. Differences were tested for significance at Week 6 using a two-sided alpha value of 0.05. RESULTS: HAL group (n=34; age range 60-80) received a mean modal dose 9.4 mg/d while OLZ group (n=83; age range 60-86) received a mean modal dose 11.9 mg/d. At Week 6, OLZ was superior to HAL on both the PANSS Total (p=0.015) and PPCT (p=0.043). Considering safety, OLZ was superior to HAL for the SAS and BAS (p<0.001; p<0.001). No spontaneous adverse event occurred more frequently with OLZ than with HAL. In patients never receiving adjunct anticholinergic therapy, no significant differences were present for anticholinergic-like side effects including blurred vision, dry mouth, constipation, or urinary difficulties. CONCLUSIONS: In elderly schizophrenia patients, olanzapine was more efficacious and better tolerated for extrapyramidal signs than was haloperidol. Olanzapine was equivalent to haloperidol for anticholinergic-like side effects when corrected for anticholingergic agents. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/14618553/Olanzapine_vs_haloperidol_in_geriatric_schizophrenia:_analysis_of_data_from_a_double_blind_controlled_trial_ L2 - https://doi.org/10.1002/gps.1007 DB - PRIME DP - Unbound Medicine ER -