[RÉALITÉ LT, a pharmacoepidemiological study of semiology and therapeutic strategy of patients with schizophrenia treated by antipsychotic loxapine in routine clinical practice].

Data concerning the clinical and therapeutic characteristics of patients with schizophrenia treated by antipsychotic in naturalistic conditions are useful. Two national pharmacoepidemiological studies were conducted in France, a retrospective survey RÉALITÉ and a prospective study RÉALITÉ LT, to examine the use of loxapine, first in acute and chronic psychotic states and second in long-term treatment prescribed for patients with schizophrenia.
The aim of RÉALITÉ LT is to specify the clinical characteristics of schizophrenic patients treated by loxapine for at least 4 months and the description of the methods of use of this antipsychotic medication during a 6-month follow-up in "real life" conditions.
RÉALITÉ LT is an epidemiologic, observational, longitudinal, prospective (during a half-year period), multicenter and national study of the prescription of loxapine in routine clinical practice. For this study, 645 patients with schizophrenia treated by loxapine were recruited, assessed by PANSS, CGI, GAF, MeDra-SOC-PT for side effects and Girerd questionnaire for compliance; statistical analysis used SAS 9.2.
Six hundred and forty-five adult patients were included and assessed at inclusion, month 3 and 6. These patients were mostly male (69%), with an average age of 41, inactive (68%), lonely with no child (79%), under psychiatric care for more than 5 years (81%), less than one third were inpatients. The subtypes of schizophrenia were paranoid (59%), disorganised (21%), undifferentiated or residual (10%), the outcome of psychotic illness was episodic (50%) or continuous (33%). The daily mean dosage of loxapine was 168,4 mg/d, in antipsychotic loxapine monotherapy (27%) or in combination with other antipsychotics (63%); it was often associated with psychotropic medications (anxiolytic [72%], antidepressant [21%], normothymic [19%]). The stability of the dosage of loxapine during the 6 months follow-up (60%) was associated with strict loxapine monotherapy or antipsychotic monotherapy (loxapine associated with other psychotropic medication). Safety, side effects and compliance were compared with previous studies.
These results are discussed, comparing the two pharmacoepidemiological studies RÉALITÉ and RÉALITÉ LT, loxapine is used in compliance with the two indications (smpc) and French guidelines (HAS, Haute Autorité de santé).
AuthorsF-R Cousin, J-C Samuelian, M Saoud, L Schmitt, M-N Vacheron, P Vidailhet, J Augendre, M Walter, I Tonelli, J-C Pascal
JournalL'Encéphale (Encephale) Vol. 38 Issue 1 Pg. 64-74 (Feb 2012) ISSN: 0013-7006 [Print] France
Vernacular TitleRÉALITÉ LT : Recherche Épidémiologique sur l'Activité de la Loxapine et ses Indications en Thérapeutique quotidiennE lors d'une utilisation à Long Terme. Étude pharmacoépidémiologique : sémiologie et stratégie thérapeutique d'une population de patients présentant des troubles schizophréniques traités par loxapine.
PMID22381726 (Publication Type: Comparative Study, English Abstract, Journal Article)
CopyrightCopyright © 2011 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.
Chemical References
  • Antipsychotic Agents
  • Loxapine
  • Adult
  • Antipsychotic Agents (adverse effects, therapeutic use)
  • Drug Therapy, Combination
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • France
  • Guideline Adherence
  • Humans
  • Long-Term Care
  • Longitudinal Studies
  • Loxapine (adverse effects, therapeutic use)
  • Male
  • Medication Adherence
  • Middle Aged
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Schizophrenia (diagnosis, drug therapy)
  • Schizophrenic Psychology

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