engleski

Olanzapine compared to fluphenazine in the treatment of acute shizophrenia

Olanzapine, a new antipsychotic agent with an atypical profile, has so far been compared to haloperidol and risperidone. It was the aim of this study to compare the safety and efficacy of olanzapine with fluphenazine. This study was conducted in three centres in Croatia. After a screening period of 2-9 days patients were randomised to olanzapine or fluphenazine. Evaluations were made weekly in the first 6 weeks, then monthly for the remaining 16 weeks. The PANSS, BPRS, and CGI rating scales were used as efficacy instruments. Safety measures included adverse events, vital signs, laboratory tests (clinical chemistry), SAS, HAS and AIMS rating scales. Sixty patients entered the study, 55 (27 olanzapine, 28 fluphenazine) were evaluable for efficacy analysis. The mean age was 34.8 years and 46.7% were male. The olanzapine treatment group showed significantly greater improvement in the BPRS total score (olanzapine -25.8 versus fluphenazine —16.5), PANSS total score (olanzapine —45.7 versus fluphenazine —29.5), and CGI severity score (olanzapine — 2.2 versus fluphenazine —1.3). A statistically significant greater proportion of olanzapine-treated patients achieved a response of at least 40% improvement in the BPRS0_6 total score than fluphenazine treated group (olanzapine 80.8% vs. Fluphenazine 57.7%). Olanzapine-treated patients reported significant^ fewer treatment-emergent adverse events than the fluphenazine group. SAS, HAS and AIMS showed that the olanzapine group improved statistically significant compared to the fluphenazine group. The study represented here suggests that olanzapine is superior in the efficacy as well as in the safety profile compared to fluphenazine.

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DOI: 10.1016/S0920-9964(97)88718-X