Abstract
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<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. Copyright © 2003 John Wiley & Sons, Ltd.