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A prospective, observational study of the safety and effectiveness of intramuscular psychotropic treatment in acutely agitated patients with schizophrenia and bipolar mania

Published online by Cambridge University Press:  15 April 2020

E. Perrin ,
E. Anand ,
Y. Dyachkova ,
T. Wagner ,
S. Frediani ,
A. Ballerini  and
the OBS-IM investigators group
E. Perrin
Affiliation:
Eli Lilly and Company, France
E. Anand*
Affiliation:
Lilly Neuroscience Research Center, Erl Wood Manor, Sunninghill Road, Windlesham, Surrey, GU20 6PH United Kingdom
Y. Dyachkova
Affiliation:
Eli Lilly and Company, Austria
T. Wagner
Affiliation:
Lilly Deutschland GmbH, Werner Reimers Street 2-4, 61350Bad Homburg, Germany
S. Frediani
Affiliation:
National Mental Health Service, Psychiatric Department of Venice, Venice, Italy
A. Ballerini
Affiliation:
Servizio Psichiatrico Diagnosi e Cura, Santa Maria Nuova Hospital, Firenze, Italy
*
*Corresponding author. Tel.: +44 7831 850 080; fax: +44 1442 241 445. E-mail address: anand_ernie@lilly.com
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Abstract

This naturalistic, observational pan-European study assessed the safety and early effectiveness of intramuscular (IM) psychotropic treatments in patients with acute agitation suffering from schizophrenia or bipolar mania. One thousand nine hundred and forty of 1945 patients completed the 24-hour observation period after initial IM treatment. Patients from 12 European countries were included (mean age 39 years; 58% male, 66% schizophrenia). IM treatment was at the physician's discretion. The primary objective was to describe the acute tolerability of IM psychotropic therapies in clinical practice, with particular emphasis on EPS. At baseline, 68% of the patients received IM monotherapy, with IM olanzapine most commonly prescribed (36%). During the first 24hours, 190 (9.8%) patients experienced EPS. The occurrence of EPS was statistically significantly lower in patients treated with IM olanzapine compared to those treated with other IM psychotropic medications (mainly typical antipsychotics and benzodiazepines): acute dystonia: 1.1%, 95% CI 0.5–2.3 and 2.9%, CI 2.0–4.0; akathisia: 2.3%, CI 1.3–3.7 and 5.5%, CI 4.3–6.9; Parkinsonism: 2.9%, CI 1.8–4.4 and 7.8%, CI 6.4–9.4, respectively. Anticholinergic treatment was given to 12% IM olanzapine versus 31% non-olanzapine treated patients. Acute agitation after 24hours was reduced by 1.68 (95% CI 1.46–1.91) points on the Clinical Global Impression of Severity (CGI-S) in IM olanzapine patients and 1.51 (95% CI 1.30–1.73) points in non-olanzapine patients. Additional psychotropic medication was required for 90% of the patients during the first 24hours of treatment. Results provide naturalistic evidence for low EPS rates and improvement of agitation with IM psychotropic medications during acute states of patients suffering from acute mania or schizophrenia.

Keywords

AgitationSchizophreniaBipolar maniaIM psychotropic drugsAcute dystoniaAkathisiaParkinsonism
Type
Original article
Information
European Psychiatry , Volume 27 , Issue 4 , May 2012 , pp. 234 - 239
Copyright
Copyright © Elsevier Masson SAS 2012

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