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A comparison of the efficacy and safety of olanzapine versus haloperidol during transition from intramuscular to oral therapy

2003; Elsevier BV; Volume: 25; Issue: 5 Linguagem: Inglês

10.1016/s0149-2918(03)80129-7

1879-114X

Pádraig Wright, Karena Meehan, Martin Birkett, Stacy Lindborg, Cindy C. Taylor, P. Morris, Alan Breier,

Psychiatric care and mental health services

Background: Acutely agitated patients with schizophrenia who receive intramuscular (IM) medications typically are switched to oral (PO) antipsychotic maintenance therapy. Objective: The goal of this study was to assess the efficacy and safety of olanzapine versus those of haloperidol during transition from IM to PO therapy. We used additional data from a previously reported trial to test the hypothesis that the reduction in agitation achieved by IM olanzapine 10 mg or IM haloperidol 7.5 mg would be maintained following transition to 4 days of PO olanzapine or PO haloperidol (5–20 mg/d for both). We also hypothesized that olanzapine would maintain its more favorble extrapyramidal symptom (EPS) safety profile. Methods: This was a multinational (hospitals in 13 countries), double-blind, randomized, controlled trial. Acutely agitated inpatients with schizophrenia were treated with 1 to 3 IM injections to olanzapine 10 mg or haloperidol 7.5 mg over 24 hours and were entered into a 4-day PO treatment period with the same medication (5–20 mg/d for both). The primary efficacy measurement was reduction in agitation, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score. Adverse events and scores on EPS rating scales were assessed. Results: A total of 311 patients (204 men, 107 women; mean [SD] age, 38.2 [11.6] years) were enrolled (131, 126, and 54 patients in the olanzapine, haloported more acute dystonia and akathisia, experienced more treatment-emergent akathisia, and required more anticholinergics. PANSS-EC scores were markedly reduced from the IM period baseline to the PO period baseline (24 hours after the first IM injection) and yet patients improved further during 4 days of PO treatment. This sustained alleviation of agitation following transition from IM to PO therapy indicates that clinicians can maintain or enhance agitation improvements when advised only to switch patients to olanzapine or haloperidol 5 to 20 mg/d. Thus, sustained alleviation of agitation during the switch from IM to 4 days of PO treatment was achieved with both olanzapine and haloperidol. However, haloperidol-treated patients experienced more acute dystonia and akathisia and required more anticholinergics than olanzapine-treated patients during both IM and PO treatments, a finding in keeping with previous reports.5,6 The low risk for acute dystonia and akathisia during treatment with IM or PO olanzapine may provide an advantage over haloperidol. Rapid calming with an IM atypical antipsychotic and subsequent transition to its PO formulation may reduce the risk for breakthrough symptoms that could result from changing between antipsychotics, and may reduce the risk for acute dystonia and akathisia. These advantages may lessen the possibility of further upsetting already distressed patients, and may promote compliance with maintenance treatment, thus lowering the potential for further acute episodes.