Comparison of intramuscular ziprasidone, olanzapine, or aripiprazole for agitation: A quantitative review of efficacy and safety

Journal of Clinical Psychiatry

Volumn 68, Issue 12, 2007, Pages 1876-1885

  Citrome, Leslie ^a,b,c  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; HALOPERIDOL; LORAZEPAM; OLANZAPINE; PLACEBO; ZIPRASIDONE;

AGITATION; ARTICLE; ASTHENIA; BIPOLAR DISORDER; BIPOLAR MANIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DELUSIONAL DISORDER; DIZZINESS; DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; DRUG MANUFACTURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EXTRAPYRAMIDAL SYMPTOM; HEADACHE; HUMAN; HYPOTENSION; MANIA; MENTAL DISEASE; MONOTHERAPY; NAUSEA; PRIORITY JOURNAL; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SOMNOLENCE; TREATMENT RESPONSE;

EID: 38049002952     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.v68n1207     Document Type: Article

References (32)

1. Citrome L. Atypical antipsychotics for acute agitation: new intramuscular options offer advantages. Postgrad Med Dec 2002;112:85-88, 94-96
2. Battaglia J. Pharmacological management of acute agitation. Drugs 2005;65:1207-1222
3. Citrome L. New treatments for agitation. Psychiatr Q 2004;75:197-213
4. Zimbroff DL, Allen MH, Battaglia J, et al. Best clinical practice with ziprasidone IM: update after 2 years of experience. CNS Spectr Sept 2005;11(suppl 17):1-15
5. Pfizer. Geodon (ziprasidone HCl) capsules, Geodon (ziprasidone mesylate) for injection for IM use only. Product information, revised May 2005. Available at: http://www.pfizer.com/pfizer/download/uspi_geodon.pdf. Accessed December 13, 2006
6. Eli Lilly. Zyprexa (olanzapine) tablets, Zyprexa Zydis (olanzapine) orally disintegrating tablets, Zyprexa IntraMuscular (olanzapine) for injection. Product information, revised November 13, 2006. Available at: http://pi.lilly.com/us/zyprexa-pi.pdf. Accessed December 13, 2006
7. Bristol-Myers Squibb. Abilify (aripiprazole) tablets, Ability (aripiprazole) DiscMelt orally disintegrating tablets, Abilify (aripiprazole) oral solution, Abilify (aripiprazole) injection for intramuscular use only. Product information, revised October 2006. Available at: http:/www.bms.com/cgi- bin/anybin.pl?sql=select%20PPI%20from%20TB_PRODUCT_PPI%20where%20PPI_SEQ= 101&key=PPI. Accessed December 13, 2006
8. Lesem MD, Zajecka JM, Swift RH, et al. Intramuscular ziprasidone, 2 mg versus 10 mg, in the short-term management of agitated psychotic patients [published correction appears in J Clin Psychiatry 2001;62:209]. J Clin Psychiatry 2001;62:12-18
9. 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
10. Breier A, Meehan K, Birkett M, et al. A double-blind, placebo-controlled dose-response comparison of intramuscular olanzapine and haloperidol in the treatment of acute agitation in schizophrenia. Arch Gen Psychiatry 2002;59:441-448
11. Eli Lilly and Company. Clinical Study Summary: FID-MC-HGHV. A double-blind dose response study comparing short acting intramuscular olanzapine, short acting intramuscular haloperidol, and intramuscular placebo in patients with schizophrenia. Available at: http:/www.lillytrials.com/ results_files/zyprexa_im/zyprexa_im_summary_3043.pdf. Accessed December 14, 2006
12. Wright P, Birkett M, David SR, et al. Double-blind, placebo-controlled comparison of intramuscular olanzapine and intramuscular haloperidol in the treatment of acute agitation in schizophrenia. Am J Psychiatry 2001;158:1149-1151
13. Eli Lilly and Company. Clinical Study Summary: FID-MC-HGHB. A double-blind randomized comparison of the efficacy and safety of short acting intramuscular olanzapine, short acting intramuscular haloperidol, and intramuscular placebo in patients with schizophrenia. Available at: http://www.lillytrials.com/results_files/zyprexa_im/zyprexa_im_summary_1898.pdf. Accessed December 14, 2006
14. Meehan K, Zhang F, David S, et al. A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania. J Clin Psychopharmacol 2001;21:389-397
15. Eli Lilly and Company. Clinical Study Summary: FID-MC-HGHW. A double-blind randomized comparison of the efficacy and safety of short-acting intramuscular olanzapine, short acting intramuscular lorazepam and intramuscular placebo in acutely agitated patients diagnosed with mania associated with bipolar disorder. Available at: http://www.lillytrials.com/results_files/ zyprexa_im/zyprexa_im_summary_3045.pdf. Accessed December 14, 2006
16. Meehan KM, Wang H, David SR, et al. Comparison of rapidly acting intramuscular olanzapine, lorazepam, and placebo: a double-blind, randomized study in acutely agitated patients with dementia. Neuropsychopharmacology 2002;26:494-504
17. Eli Lilly and Company. Clinical Study Summary: HD-MC-HGHX. A double-blind randomized comparison of the efficacy and safety of short-acting intramuscular olanzapine, short acting intramuscular lorazepam and intramuscular placebo in treating agitation in patients with dementia of the Alzheimer's type, vascular dementia, and mixed dementia. Available at: http://www.lillytrials.com/ results_files/zyprexa_im/zyprexa_im_summary_3047.pdf. Accessed December 14, 2006
18. Andrezina R, Josiassen RC, Marcus RN, et al. Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison with intramuscular haloperidol. Psychopharmacology (Berl) 2006;188:281-292
19. Tran-Johnson TK, Sack DA, Marcus RN, et al. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2007;68:111-119
20. Oren D, Iwamoto T, Marcus R, et al. Intramuscular aripiprazole vs placebo for agitation in acute mania [poster II-69]. Presented at the 45th annual meeting of the New Clinical Drug Evaluation Unit; June 6-9, 2005; Boca Raton, Fla
21. Citrome L, Stroup TS. Schizophrenia, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and number needed to treat: how can CATIE inform clinicians? Int J Clin Pract 2006;60:933-940
22. Citrome L. Dissecting clinical trials with "number needed to treat." Curr Psychiatry March 2007;6:66-71
23. Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry 2006;59:990-996
24. Altman DG. Confidence intervals for the number needed to treat. BMJ 1998;317:1309-1312
25. United States Food and Drug Administration Pharmacological 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 December 17, 2006
26. United States Food and Drug Administration Pharmacological Drugs Advisory committee. Briefing document for Zyprexa intramuscular (olanzapine for injection). February 14, 2001. Available at: http://www.fda.gov/OHRMS/DOCKETS/ AC/01/briefing/3685b1_01_lilly.pdf. Accessed December 14, 2006
27. Sorsaburu S, Hornbuckle K, Blake DS, et al. The first 21 months of safety experience with post-marketing use of olanzapine's intramuscular formulation. In: New Research Program and Abstracts of the 159th Annual Meeting of the American Psychiatric Association; May 20-25, 2006; Toronto, Ontario, Canada. Abstract NR432;179
28. Eli Lilly. Important Safety Information. Dear Healthcare Professional letter signed by Dr. Joanna Nakielny, Sept 28, 2004
29. Eli Lilly. Annex I. Summary of Product Characteristics. Available at: http://www.emea.eu.int/humandocs/Humans/EPAR/zyprexazyprexa.htm. Accessed December 13, 2006
30. Preval H, Klotz SG, Southard R, et al. Rapid-acting IM ziprasidone in a psychiatric emergency service: a naturalistic study. Gen Hosp Psychiatry 2005;27:140-144
31. Swift RH, Harrigan EP, Cappelleri JC, et al. Validation of the behavioral activity rating scale (BARS): a novel measure of activity in agitated patients. J Psychiatr Res 2002;36:87-95
32. 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