Hostname: page-component-848d4c4894-75dct Total loading time: 0 Render date: 2024-04-30T13:56:51.425Z Has data issue: false hasContentIssue false
  • English
  • Français

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.
Get access Rights & Permissions [Opens in a new window]

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Allen, MH, Currier, GW. Use of restraints and pharmacotherapy in academic psychiatric emergency services. Gen Hosp Psychiatry. 2004;26:42–49.CrossRefGoogle ScholarPubMed
2.Fisher, WA. Restraint and seclusion: A review of the literature. Am J Psychiatry. 1994;151:1584–1591.Google ScholarPubMed
3.Sundram, CJ, Stack, EW, Benjamin, WP. Restraint and Seclusion Practices in New York State Psychiatric Facilities. Albany, NY: New York State Commission on Quality of Care for the Mentally Disabled; 1994.Google Scholar
4.Currier, GW, Allen, MH. American Association for Emergency Psychiatry survey, I: Psychiatric Emergency Service Structure and Function. Presented at: the 51st American Psychiatric Association Institute on Psychiatric Services; October 29-November 2, 1999; New Orleans, LA.Google Scholar
5.Medical Directors Council of the National Association of State Mental Health Program Directors. Reducing the Use of Seclusion and Restraint: Findings, Strategies, and Recommendations. Alexandria, VA: National Association of State Mental Health Program Directors; 1999.Google Scholar
6.Altimari, D, Blint, DF, Weiss, EM, et al.Deadly restraint. Hartford Courant. October 1998. Summary available at: http://www.nami.org/update/990324.html.Google Scholar
7.Allen, MH, Currier, GW, Hughes, DH, Reyes-Harde, M, Docherty, JP. Expert Consensus Panel for Behavioral Emergencies. The Expert Consensus Guideline Series. Treatment of behavioral emergencies. Postgrad Med. 2001;(spec no):1–88.Google ScholarPubMed
8.Allen, MH, Carpenter, D, Sheets, JL, et al.What do consumers say they want and need during a psychiatric emergency? J Psychiatr Pract. 2003;9:39–58.Google Scholar
9.National Collaborating Centre for Mental Health, National Institute for Clinical Excellence (NICE). Schizophrenia: Full National Clinical Guideline on Core Interventions in Primary and Secondary Care. London, England: The Royal College of Psychiatrists: Gaskell Books; 2003.Google Scholar
10.Casey, DE. Motor and mental aspects of acute extrapyramidal syndromes. Acta Psychiatr Scand Suppl. 1994;89(suppl 380):14–20.CrossRefGoogle Scholar
11.King, DJ, Burke, M, Lucas, RA. Antipsychotic drug-induced dysphoria. Br J Psychiatry. 1995;167:480–482.Google Scholar
12.Glassman, AH, Bigger, JT Jr.Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry. 2001;158(11):1774–1782.Google Scholar
13.Hassaballa, HA, Balk, RA. Torsade de pointes associated with the administration of intravenous haloperidol: A review of the literature and practical guidelines for use. Expert Opin Drug Saf. 2003;2:543–547.Google Scholar
14.Allen, MH. Managing the agitated psychotic patient: a reappraisal of the evidence. J Clin Psychiatry. 2000;61(suppl 14):11–20.Google Scholar
15.Battaglia, J. Pharmacological management of acute agitation. Drugs. 2005;65:1207–1222.Google Scholar
16.Battaglia, J, Moss, S, Rush, J, et al.Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study. Am J Emerg Med. 1997;15:335–340.Google Scholar
17.Awad, AG, Voruganti, LNP, Heslegrave, RJ. Assessment of the patient's subjective experiences in acute neuroleptic treatment: implications for compliance and outcome. Int Clin Psychopharmacol. 1996;11(Suppl 2):55–60.CrossRefGoogle ScholarPubMed
18.Voruganti, L, Cortese, L, Oyewumi, L, Cernovsky, Z, Zirul, S, Awad, A. Comparative evaluation of conventional and novel antipsychotic drugs with reference to their subjective tolerability, side-effect profile and impact on quality of life. Schizophr Res. 2000;43:135–145.CrossRefGoogle ScholarPubMed
19.Geodon (ziprasidone mesylate) for Injection. [Package insert]. New York, NY: Pfizer, Inc: August, 2004.Google Scholar
20.FDA Psychopharmacological Drugs Advisory Committee. Briefing document for ziprasidone mesylate for intramuscular injection. February 15, 2001. Available at: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3685b2_01_pfizer.pdf. accessed January 24, 2005.Google Scholar
21.Lesem, MD, Zajecka, JM, Swift, RH, et al.Intramuscular ziprasidone, 2 mg versus 10 mg, in the short-term management of agitated psychotic patients. J Clin Psychiatry. 2001;62:12–18.CrossRefGoogle ScholarPubMed
22.Daniel, DG, Potkin, SG, Reeves, KR, et al.Intramuscular (IM) ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis: A double-blind, randomized trial. Psychopharmacology (Berl). 2001;155:128–134.Google Scholar
23.Preskorn, SH. Pharmacokinetics and therapeutics of intramuscular ziprasidone. Clin Pharmacokinetics. 2005. In press.Google ScholarPubMed
24.Swift, RH, Harrigan, EP, Cappelleri, JC, et al.Validation of the behavioural activity rating scale (BARS): a novel measure of activity in agitated patients. J Psychiatr Res. 2002;36:87–95.CrossRefGoogle Scholar
25.Brook, S, Lucey, JV, Gunn, KP. Intramuscular ziprasidone compared with intramuscular haloperidol in the treatment of acute psychosis. Ziprasidone I.M. Study Group. J Clin Psychiatry. 2000;61:933–941.Google Scholar
26.Overall, JE, Gorham, DR. The Brief Psychiatric Rating Scale (BPRS): Recent developments in ascertainment and scaling. Psychopharmacol Bull. 1988;24:97–99.Google Scholar
27.Brook, S, Walden, J, Benattia, I, Siu, CO, Romano, SJ. Ziprasidone and haloperidol in the treatment of acute exacerbation of schizophrenia and schizoaffective disorder: comparison of intramuscular and oral formulations in a 6-week, randomized, blinded-assessment study. Psychopharmacology (Berl). 2005;178:514–523.CrossRefGoogle Scholar
28.Daniel, D, Zimbroff, DL, Swift, RH, Harrigan, EP. The tolerability of intramuscular ziprasidone and haloperidol treatment and the transition to oral therapy. Int Clin Psychopharmacol. 2004;19:9–15.Google Scholar
29.Citrome, L, Brook, S, Loebel, A, Mandel, FS, Weissman, A. Ziprasidone versus haloperidol for the treatment of agitation. Neuropsychopharmacology. 2004;29(Suppl 1):S111.Google Scholar
30.Gueorgguieva, R, Krystal, JH. Move over ANOVA. Arch Gen Psychiatry. 2004;61:310–317.Google Scholar
31.Rabinowitz, J, Avnon, M, Rosenberg, V. Effect of clozapine on physical and verbal aggression. Schizophr Res. 1996;22(3):249–255.Google Scholar
32.Volavka, J, Citrome, L. Atypical antipsychotics in the treatment of the persistently aggressive psychotic patient: methodological concerns. Schizophr Res. 1999;35(Suppl):S23–33.CrossRefGoogle ScholarPubMed
33.Schillerstrom, TL, Schillerstrom, JE, Taylor, SE. Laboratory findings in emergently medicated psychiatry patients. Gen Hosp Psychiatry. 2004;26:411–414.Google Scholar
34.Beedham, C, Miceli, JJ, Obach, RS. Ziprasidone metabolism, aldehyde oxidase, and clinical implications. J Clin Psychopharmacol. 2003;23:229–232.Google Scholar
35.Prakash, C, Kamel, A, Cui, D, et al.Identification of the major human liver cytochrome P450 isoform(s) responsible for the formation of the primary metabolites of ziprasidone and prediction of possible drug interactions. Br J Clin Pharmacol. 2000;49(suppl 1):35S–42S.Google Scholar
36.Miceli, JJ, Anziano, RJ, Robarge, L, et al.The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers. Br J Clin Pharmacol. 2000;49(suppl 1):65S–70S.Google Scholar
37.Miceli, JJ, Smith, M, Robarge, L, Morse, T, Laurent, A. The effects of ketoconazole on ziprasidone pharmacokinetics – a placebo-controlled crossover study in healthy volunteers. Br J Clin Pharmacol. 2000b;49(suppl 1):71S–76S.CrossRefGoogle ScholarPubMed
38.Daniel, D, Brook, S, Benattia, I. Efficacy of intramuscular ziprasidone without adjunctive benzodiazepines. Poster presented at: the 16th Congress of the European College of Neuropsychopharmacology; September 20-24, 2003; Prague, Czech Republic.Google Scholar
39.ZYPREXA® Olanzapine Tablets, ZYPREXA® ZYDIS® Olanzapine Orally Disintegrating Tablets, ZYPREXA® IntraMuscular Olanzapine for Injection [Package Insert]. Indianapolis, IN; Eli Lilly and Company; 2005. Available at: www.ZYPREXA.com. Accessed July 13, 2005.Google Scholar
40.Miceli, JJ, Anziano, MS, Swift, RH, et al.IM ziprasidone and IM haloperidol show comparable QTc effects at Cmax. Poster presented at: 156th Annual Meeting of the American Psychiatric Assciation; May 17-22, 2003; San Francisco, CA.Google Scholar
41.Shale, JH, Shale, CM, Mastin, WD. A review of the safety and efficacy of droperidol for the rapid sedation of severely agitated and violent patients. J Clin Psychiatry. 2003;64(5):500–505.Google Scholar
42.Heinrich, TW, Biblo, LA, Schneider, J. Torsades de pointes associated with ziprasidone. Psychosomatics. 2005. In press.Google Scholar
43.FDA Psychopharmacological Drugs Advisory Committee. Briefing document for Zeldox® capsules (Ziprasidone HCl). July 19, 2000. Available at: http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3619b1a.pdf. Accessed January 24, 2005.Google Scholar
44.Freeman, J, Platt, R. Erythromycin prolongs the QTc interval among patients with pneumonia. Pharmacoepidemiol Drug Saf. 1997;6:13–19.Google Scholar
45.Harrigan, EP, Miceli, JJ, Anziano, R, et al.A randomized evaluation of the effects of six antipsychotic agents on QTc, in the absence and presence of metabolic inhibition. J Clin Psychopharmacol. 2004;24(1):62–69.CrossRefGoogle ScholarPubMed
46.Burton, S, Heslop, K, Harrison, K, Barnes, M. Ziprasidone overdose. Am J Psychiatry. 2000;157:835.Google Scholar
47.House, M. Overdose of ziprasidone. Am J Psychiatry. 2002;159:1061–1062.Google Scholar
48.Bryant, SM, Zilberstein, J, Cumpston, KL, Magdziarz, DD, Costerisan, DD. A case series of ziprasidone overdoses. Vet Hum Toxicol. 2003;45:81–82Google Scholar
49.Preval, H, Klotz, SG, Southard, R, Francis, A. Rapid-acting IM ziprasidone in the psychiatric emergency service: a naturalistic study. Gen Hosp Psychiatry. 2005;27:140–144.Google Scholar
50.Hick, JL, Smith, SW, Lynch, MT. Metabolic acidosis in restraint-associated cardiac arrest: a case series. Acad Emerg Med. 1999;6(3):239–243.Google Scholar
51.Miner, JR, McCoy, C. Use of a standardized sedation scale in intoxicated patients in the emergency department. Acad Emerg Med. 2002;9:536.Google Scholar
52.Miner, JR, McCoy, C, Biros, MA. Standardized intoxication scale vs breath ethanol level as a predictor of observation time in the emergency department. Academic Emer Med. 2003;10:520.Google Scholar
53.Ely, EW, Shintani, A, Truman, B, et al.Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004a;291:1753–1762.CrossRefGoogle ScholarPubMed
54.Milbrandt, EB, Deppen, S, Harrison, PL, et al.Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004;32(4):955–962.Google Scholar
55.Jacobi, J, Fraser, GL, Coursin, DB, et al.Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002;30:119–141.Google Scholar
56.Ely, EW, Stephens, RK, Jackson, JC, et al.Current opinions regarding the importance, diagnosis, and management of delirium in the intensive care unit: a survey of 912 healthcare professionals. Crit Care Med. 2004b;32:106–112.Google Scholar
57.Data on file. Pfizer Inc; New York, NY.Google Scholar
58.Keck, PE Jr, Versiani, M, Potkin, S, West, SA, Giller, E, Ice, K. Ziprasidone in Mania Study Group. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry. 2003;160:741–748.Google Scholar
59.Russell, JM, Mackel, JA, Leaderer, MC. Economic model of IM ziprasidone and haloperidol in acute agitation. Poster presented at: the American Psychiatric Association 55th Institute on Psychiatric Services; October 29–November 2, 2003; Boston, Massachusetts.Google Scholar
60.Ely, EW, Truman, B, Shintani, A, et al.Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003;289(22):2983–2991.Google Scholar
61.Ely, EW, Margolin, R, Francis, J, et al.Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29:1370–1379.Google Scholar