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Thursday 01 December 2005

Naturalistic study of intramuscular ziprasidone versus conventional agents in agitated elderly patients: retrospective findings from a psychiatric emergency service.

By: Kohen I, Preval H, Southard R, Francis A.

Am J Geriatr Pharmacother 2005 Dec;3(4):240-5

BACKGROUND: The newer atypical antipsychotics have gained prominence as first-line oral agents to treat severe agitation, but their use in the psychiatric emergency service (PES) setting has been limited because of the unavailability of parenteral formulations. The advent of parenteral formulations of atypical antipsychotics, beginning with ziprasidone in 2002, might afford an alternative treatment option. OBJECTIVE: The objective of this article was to determine the effectiveness and tolerability of i.m. ziprasidone used to treat agitation in elderly patients. METHODS: In this data analysis, the PES database at the Department of Psychiatry and Behavioral Science, School of Medicine, State University of New York, Stony Brook, New York, was searched for records of patients aged > or = 65 years who received a single 20-mg dose of i.m. ziprasidone for the treatment of acute agitation. Efficacy data from these patients were compared with those from an age- and gender-matched sample that received conventional treatment (CT group) with i.m. haloperidol, with or without lorazepam. Data were also included from a previous naturalistic outcomes study to determine the effectiveness and tolerability of i.m. ziprasidone in patients treated at the PES at Stony Brook. Additional records were identified using a search of pharmacy and restraint records for PES-treated geriatric patients who received i.m. ziprasidone over a 2.5-year period beginning in late 2002, when i.m. ziprasidone became available. In some patients in the ziprasidone group, the effects of the drug on agitation were assessed prospectively by blinded psychiatrists using the Behavioural Activity Rating Scale (BARS) (1--difficult or unable to arouse to 7--violent, requires restraint). Also included in the analysis were data concerning use of rescue medication (oral or parenteral) other than the study drug within 2 hours of initial treatment, restraint time, and adverse events (changes in vital sign measurements and electrocardiography [ECG]). RESULTS: The database revealed 15 patients who received ziprasidone (9 men, 6 women; age range, 65-87 years) and 20 patients who were included in the CT sample (13 men, 7 women; age range, 65-88 years). In the 6 cases rated on the BARS, the mean (SE) baseline score was high (6.8 [0.1]), with a decrease to 4.0 (0.4) (P < 0.05) at 45 minutes after study drug administration and to 2.8 (0.4) (P < 0.01) at 120 minutes. Rescue medication was needed in 4 ziprasidone cases and 2 CT cases (P = NS), and mean (SE) restraint times did not vary significantly between groups (ziprasidone [n = 12], 85 [15] minutes; CT [n = 17], 83 [12] minutes). No clinically significant effects on blood pressure or heart rate were noted, and no cardiac or other adverse events were reported. ECG results with ziprasidone (n = 3) or CT (n = 6) were unremarkable. CONCLUSIONS: The results of this data analysis of the effects of i.m. ziprasidone suggest that this agent was similarly effective compared with CT and was well tolerated in this geriatric population with acute agitation presenting to a PES. Ziprasidone might be an effective, well-tolerated treatment option for acute agitation in elderly patients presenting to a PES.

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