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Chapter 33. Ziprasidone

John W. Newcomer, M.D.; Elise M. Fallucco, M.D.
DOI: 10.1176/appi.books.9781585623860.440629

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Excerpt

Ziprasidone (CP-88059) is an atypical, or second-generation, antipsychotic agent that has demonstrated activity for treating positive, negative, cognitive, and affective symptoms of schizophrenia and schizoaffective disorder and for treating mania and mixed states in bipolar disorder, with limited adverse extrapyramidal, sedative, anticholinergic, and cardiometabolic effects. Ziprasidone was first synthesized on the Pfizer Central Research campus in Groton, Connecticut. Both the oral and intramuscular formulations of this antipsychotic were initially part of a new drug application for the treatment of psychotic disorders submitted to the U.S. Food and Drug Administration (FDA) under the product name Zeldox in 1997. Because of concerns regarding an observed increase in the mean duration of the QT interval, an electrocardiographic measure of the ventricular depolarization and repolarization phases of cardiac conduction, the application was not initially approved. Further studies, designed in collaboration with the FDA, quantified the limited extent of this effect seen with ziprasidone compared with the effect seen with other agents in wide use; these studies established an approvable level of safety for ziprasidone with respect to cardiac conduction and a benchmark for the approach to evaluating drug effects on the QT interval that has subsequently been applied to other agents evaluated by the FDA. The FDA approved oral ziprasidone in February 2001 under the trade name Geodon for the treatment of schizophrenia. The intramuscular formulation received FDA approval in 2002 for the treatment of acute agitation due to schizophrenia. In August 2004, oral ziprasidone received FDA approval for the treatment of bipolar mania, including manic and mixed episodes. At the time of writing, ziprasidone has received regulatory approval and is available in over 70 countries, usually under the trade name Zeldox, with more than 1.08 million patient-years of drug exposure.

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FIGURE 33–1. Chemical structure of ziprasidone.

FIGURE 33–2. Histamine1 (H1) receptor affinity predicts antipsychotic-induced weight gain.ARI = aripiprazole; CLO = clozapine; HAL = haloperidol; K1 = binding affinity; OLA = olanzapine; QTP = quetiapine; RIS = risperidone; ZIP = ziprasidone.Source. Adapted from Kroeze et al. 2003.

FIGURE 33–3. Relationship between dopamine2 (D2) and serotonin2 (5-HT2) receptor occupancy and ziprasidone plasma levels in 16 patients with schizophrenia or schizoaffective disorder receiving therapeutic dosages of ziprasidone.Dotted straight lines represent minimal D2 receptor occupancy and plasma concentration that would be expected to be associated with a clinical antipsychotic response, corresponding to a ziprasidone dosage of approximately 120 mg/day.Source. Adapted from Mamo et al. 2004.

FIGURE 33–4. Major metabolic pathways of ziprasidone.BITP = benzisothiazole piperazine; CYP = cytochrome P450; M = metabolite; TMT = thiol methyltransferase.Source. Adapted from U.S. Food and Drug Administration Pharmacological Drugs Advisory Committee: Briefing Document for Ziprasidone Mesylate for Intramuscular Injection (Figure 2 [Metabolism of Ziprasidone in Humans: Proposed Metabolic Pathways to Major Circulating Metabolites], p. 5). February 15, 2001. Available at: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3685b2_01_pfizer.pdf.

FIGURE 33–5. Effect of ziprasidone on mania: rating scale scores in patients with bipolar disorder receiving 21-day randomized treatment with ziprasidone or placebo.*P <0.003 (F test), placebo-treated patients versus ziprasidone-treated patients.**P <0.001 (F test), placebo-treated patients and ziprasidone-treated patients (P <0.001, F test).Source. Adapted from P. E. Keck et al. 2003b.

FIGURE 33–6. Time course of weight change over 58 weeks after switching to ziprasidone.Previous treatments were conventional antipsychotics (line with circles; n = 71), risperidone (line with squares; n = 43), or olanzapine (line with triangles; n = 71). Individual observed cases within each treatment group are also shown (circle = conventional agent: baseline weight, 198 lb [90 kg]; square = risperidone: baseline weight, 194.9 lb [88.6 kg]; triangle = olanzapine: baseline weight, 210.3 lb [95.6 kg]).LS = least-squares analysis; MMRM = mixed-model repeated measures analysis; OC = observed case analysis.*P <0.01 versus baseline (MMRM and OC).Source. Adapted from Weiden PJ, Newcomer JW, Loebel AD, et al.: "Long-Term Changes in Weight and Plasma Lipids During Maintenance Treatment With Ziprasidone." Neuropsychopharmacology 33:985–994, 2008 (Figure 1, p. 988).
Table Reference Number
TABLE 33–1. Binding affinities of atypical antipsychotics (compared with haloperidol) for human receptors and rat transporters

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1.
Ziprasidone has a low propensity to produce weight gain. Which of the following pharmacological effects of ziprasidone may explain this clinical finding?
2.
Which of the following daily dosage ranges of ziprasidone is associated with lower rates of medication discontinuation?
3.
Ziprasidone’s pharmacokinetics are significantly affected by which of the following?
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