engleski

Efficacy, tolerability and safety of intramuscular olanzapine

Four large multicenter, doble blind and placebo- controlled clinical trials were conducted to assess efficacy, tolerability and safety of the intramuscular olanzapine in psychiatric disorders involving acute agitation (schizophrenia, dementia and bipolar disorder with current manic episode).In a study of the acute agitation of schizophrenia (N=311) significant defferences (in addition to those showing higher efficacyof both olanzapine and haloperidol vs.placebo)were observed between patients given olanzapine and those given haloperidol in excited component of the Positive and Negative Syndrom Scale (PANSS-EC) at 15, 30 and 45 minutes after the first injection. The response rate (reduction of > or = 40% in the PANSS-EC was 73.3% in olanzapine-treated patients and 69% in haloperidol treated patients. Statisticaly significant defferences appeared in rates of acute dystonia between olanzapine- and haloperidol- treated groups (none vs.7.1%), EPS (0.8% vs. 5.6%)and in concomitant anticholinergics use (4.6%vs. 20.6%). No significant changes in QTc interval were observed. Comparable results were displayed in study of acutely agitatedbipolar patients with current manic episode (N=201). In this study olanzapine-treated patinets, at 1/2, 1, 1 1/2 and 2 hours after first injection , showed a significantly greater reduction in PANSS-EC agitation scores than both lorazepam- and placebo-treated patients. Response rate 2 hours after first injection was in olanzapine group (80.6%) significantly higher than in lorazepam group (64.7%). Safety measures did not display any significant differences between three treatment.

intramuscular ; olanzapine ; efficacy

Cited/abstracted in Excerpta Medica (EMBASE), Psychological abstracts/PsycINFO