Olanzapine vs haloperidol in geriatric schizophrenia: analysis of data from a double-blind controlled trial
| Autor: | Gerald A. Maguire, Martin Dossenbach, G. Tollefson, Alan Breier, Bruce J. Kinon, Franklin Porter Bymaster, John S. Kennedy, Shahrokh Golshan, J.A. Gilmore, Christopher Kaiser, Dilip V. Jeste, T. Sanger |
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| Rok vydání: | 2003 |
| Předmět: |
Olanzapine
medicine.medical_specialty medicine.drug_class Cholinergic Antagonists law.invention Benzodiazepines Randomized controlled trial Double-Blind Method law Internal medicine medicine Anticholinergic Haloperidol Humans Adverse effect Psychiatry Aged Aged 80 and over Psychiatric Status Rating Scales Dose-Response Relationship Drug Age Factors Repeated measures design Pirenzepine Middle Aged medicine.disease Barnes Akathisia Scale Psychiatry and Mental health Treatment Outcome Schizophrenia Geriatrics and Gerontology Psychology medicine.drug Antipsychotic Agents |
| Zdroj: | International journal of geriatric psychiatry. 18(11) |
| ISSN: | 0885-6230 |
| Popis: | Objectives To compare the six-week clinical response and safety profile of schizophrenia patients, age ≥60 years, receiving olanzapine (OLZ) vs haloperidol (HAL) in a double blind, randomized trial. Methods Double-blind data on patients age ≥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 |
| Databáze: | OpenAIRE |
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