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Best Clinical Practice With Ziprasidone IM: Update After 2 Years of Experience

Published online by Cambridge University Press:  07 November 2014

Dan L. Zimbroff ,
Michael H. Allen ,
John Battaglia ,
Leslie Citrome ,
Avrim Fishkind ,
Andrew Francis ,
Daniel L. Herr ,
Douglas Hughes ,
Marc Martel  and
Horacio Preval
...Show all authors
Michael H. Allen
Affiliation:
Dr. Battaglia is medical director at the Program of Assertive Community Treatment at the, Mendota Mental Health Institutein Madison, Wisconsin. He has served as a consultant to and has received honoraria from Eli Lilly and Pfizer.
John Battaglia
Affiliation:
Dr. Citrome is director of the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York, and professor of psychiatry at the, New York University School of Medicinein New York City. He has received research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Organon, Pfizer, Repligen; and has received honoraria for serving on the advisory boards and speaker's bureaus of Abbott, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Novartis, and Pfizer.
Leslie Citrome
Affiliation:
Dr. Fishkind is medical director at the Neuropsychiatric Center of Houston in Texas. He has received honoraria from Pfizer.
Avrim Fishkind
Affiliation:
Dr. Francis is professor of psychiatry at the, State University of New Yorkat Stony Brook. He has received honoraria from Pfizer.
Andrew Francis
Affiliation:
Dr. Herr is medical director of the Surgical Intensive Care Unit at, Washington Hospital Centerin Washington, DC. He has received honoraria from Pfizer.
Daniel L. Herr
Affiliation:
Dr. Hughes is associate professor at, Boston University School of Medicinein Boston, Massachusetts. He has served as a consultant to Janssen and Pfizer; and has received honoraria from Pfizer.
Douglas Hughes
Affiliation:
Dr. Martel is assistant professor in the, Department of Emergency Medicineat Hennepin County Medical Center in Minneapolis, Minnesota. He has received honoraria from Pfizer.
Marc Martel
Affiliation:
Dr. Preval is medical director of the Comprehensive Psychiatric Emergency Program and assistant clinical professor of psychiatry and emergency medicine at the, State University of New Yorkat Stony Brook. He is a consultant speaker for and has received honoraria from Pfizer.
Horacio Preval
Affiliation:
Ms. Ross is a medical writer/editor at Ross Editorial, in Independence, Virginia. She has received honoraria or payments for consultancy work from Abbott, AstraZeneca, Pfizer, and several medical communications firms with a variety of clients.
Ruth Ross
Affiliation:
Dr. Zimbroff is medical director at Pacific Clinical Research Medical Group in Upland, California. He has served as a consultant to Bristol-Myers Squibb and Pfizer; has been a member of the speaker's bureaus of Bristol-Myers Squibb, Otsuka, and Pfizer; and has received grant/research contracts and support from Bristol-Myers Squibb, Cephalon, DOV, Forest, GlaxoSmithKline, Indevus, Merck, Novartis, Organon, Pfizer, Sanofi-Synthelabo, and Solvay.
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Abstract

Acute agitation is a common psychiatric emergency often treated with intramuscular (IM) medication when rapid control is necessary or the patient refuses to take an oral agent. Conventional IM antipsychotics are associated with side effects, particularly movement disorders, that may alarm patients and render them unreceptive to taking these medications again. Ziprasidone (Geodon®) is the first second-generation, or atypical, antipsychotic to become available in an IM formulation. Ziprasidone IM was approved by the Food and Drug Administration in 2002 for the treatment of agitation in patients with schizophrenia. In October 2004, a roundtable panel of physicians with extensive experience in the management of acutely agitated patients met to review the first 2 years of experience with this agent. This monograph, a product of that meeting, discusses clinical experience to date with ziprasidone IM and offers recommendations on its use in various settings.

In clinical trials, patients treated with ziprasidone IM demonstrated significant and rapid (within 15-30 minutes) reduction in agitation and improvement in psychotic symptoms, agitation, and hostility to an extent greater than or equal to that attained with haloperidol IM. Tolerability of ziprasidone IM was superior to that of haloperidol IM, with a lower burden of movement disorders. Clinical trials have also shown that ziprasidone IM can be administered with benzodiazepines without adverse consequences. Transition from IM to oral ziprasidone has been well tolerated, with maintenance of symptom control. The most common adverse events associated with ziprasidone IM were insomnia, headache, and dizziness in fixed-dose trials and insomnia and hypertension in flexible-dose trials. No consistent pattern of escalating incidence of adverse events with escalating ziprasidone doses has been observed. Changes in QTc interval associated with ziprasidone at peak serum concentrations are modest and comparable to those seen with haloperidol IM. Results of randomized clinical trials of ziprasidone IM have been corroborated in studies in real-world treatment settings involving patients with extreme agitation or a recent history of alcohol or substance abuse. In these circumstances, clinically significant improvement was seen within 30 minutes of ziprasidone IM administration, without regard to the suspected underlying etiology of agitation. Agents with a good safety/tolerability profile, such as ziprasidone IM, may be more cost effective long term than older agents, due to reduced incidence of acute adverse effects (eg, acute dystonia) that often require extended periods of observation. Additional trials of ziprasidone IM in agitated patients in a variety of clinical settings are warranted to generate comparative risk/benefit data with conventional agents and other second-generation antipsychotics.

Type
Research Article
Information
CNS Spectrums , Volume 10 , Issue S11 , 2005 , pp. 1 - 15
Copyright
Copyright © Cambridge University Press 2005

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