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The use of ziprasidone in clinical practice: Analysis of pharmacokinetic and pharmacodynamic aspects from data of a drug monitoring survey

Published online by Cambridge University Press:  16 April 2020

Friederike Vogel ,
Reinhard Gansmüller ,
Thomas Leiblein ,
Otto Dietmaier ,
Hans Wassmuth ,
Gerhard Gründer  and
Christoph Hiemke
Friederike Vogel
Affiliation:
Department of Psychiatry and Psychotherapy, University of Mainz, Mainz, Germany
Reinhard Gansmüller
Affiliation:
Department of Psychiatry and Psychotherapy, University of Mainz, Mainz, Germany
Thomas Leiblein
Affiliation:
Department of Psychiatry and Psychotherapy, University of Mainz, Mainz, Germany
Otto Dietmaier
Affiliation:
Psychiatric Hospital, Klinikum am Weissenhof, D-74189Weinsberg, Germany
Hans Wassmuth
Affiliation:
Psychiatric Hospital, Klinikum am Weissenhof, D-74189Weinsberg, Germany
Gerhard Gründer
Affiliation:
Department of Psychiatry and Psychotherapy, RWTH Aachen University, Aachen, Germany
Christoph Hiemke*
Affiliation:
Department of Psychiatry and Psychotherapy, University of Mainz, Mainz, Germany
*
*Corresponding author. Department of Psychiatry and Psychotherapy, University of Mainz, Untere Zahlbacher Street 8, D-55131 Mainz, Germany. Tel.: +49 6131 17 7131; fax: +49 6131 17 6789. E-mail address: [email protected] (C. Hiemke).
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Abstract

This study related clinical effects to daily doses and serum concentrations of ziprasidone by retrospective analysis of data from a therapeutic drug monitoring (TDM) survey established for patients treated with the new antipsychotic drug. In the total sample of 463 patients ziprasidone doses ranged between 20 and 320 mg/d and correlated significantly (r2 = 0.093, P < 0.01) with serum concentrations. The latter were highly variable within and between individual patients (between patients median 67 ng/ml, 25–75th percentile 40–103 ng/ml). Pharmacokinetic interactions with comedication played a minor role. According to the clinical global impressions (CGI) scale most of the 348 patients who were under antipsychotic monotherapy with ziprasidone were either much or very much improved (43.3 and 17.3%, respectively). The previously proposed therapeutic range of 50–130 ng/ml ziprasidone in serum or plasma, which can in effect be used interchangeable, was confirmed. In patients who were at least much improved and defined as “responders” mean serum concentrations of ziprasidone were 80 ng/ml and 78 ng/ml in patients who did not reach this improvement score. In patients with serum levels above or below 50 ng/ml, the number of responders was 66 or 63%, respectively. The difference between the two groups was not significant (P = 0.375), and improvement or side effects did not correlate significantly (P > 0.05) with doses or serum levels. It is concluded that TDM of ziprasidone may be useful for treatment optimization because of highly variable serum concentrations resulting under therapeutically recommended doses of the drug.

Keywords

ZiprasidoneTherapeutic drug monitoringSchizophreniaPlasma concentrationDrug interactions
Type
Original article
Information
European Psychiatry , Volume 24 , Issue 3 , April 2009 , pp. 143 - 148
Copyright
Copyright © Elsevier Masson SAS 2009

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References

Baumann, P., Hiemke, C., Ulrich, S., Eckermann, G., Gaertner, I., Gerlach, M.et al.Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) The AGNP-TDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 2004;37:243–265CrossRefGoogle Scholar
Beedham, C., Miceli, J.J., Obach, R.S.Ziprasidone metabolism, aldehyde oxidase, and clinical implications. J Clin Psychopharmacol 2003;23:229–232CrossRefGoogle ScholarPubMed
Caccia, S.Biotransformation of post-clozapine antipsychotics: pharmacological implications. Clin Pharmacokinet 2000;38:393–414CrossRefGoogle ScholarPubMed
Caley, C.F., Cooper, C.K.Ziprasidone: the fifth atypical antipsychotic. Ann Pharmacother 2002;36:839–851CrossRefGoogle ScholarPubMed
Deutschman, D.A., Deutschman, D.H.High-dose ziprasidone in treatment-resistant schizophrenia and affective spectrum disorders: a case series. J Clin Psychopharmacol 2007 Oct;27(5):513–514CrossRefGoogle Scholar
Eilers, R.Therapeutic drug monitoring for the treatment of psychiatric disorders. Clinical use and cost effectiveness. Clin Pharmacokinet 1995;29:442–450CrossRefGoogle ScholarPubMed
Farde, L., Wiesel, F.A., Halldin, C., Sedvall, G.Central D2-dopamine receptor occupancy in schizophrenic patients treated with antipsychotic drugs. Arch Gen Psychiatry 1988;45:71–76CrossRefGoogle ScholarPubMed
Hamelin, B.A., Allard, S., Laplante, L., Miceli, J., Wilner, K.D., Tremblay, J.et al.The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone. Pharmacotherapy 1998;18:9–15Google ScholarPubMed
Hiemke, C., Dragicevic, A., Gründer, G., Härtter, S., Sachse, J., Vernaleken, I.et al.Therapeutic monitoring of new antipsychotic drugs. Ther Drug Monit 2004;26:156–160CrossRefGoogle ScholarPubMed
Joyce, A.T., Harrison, D.J., Loebel, A.D., Carter, C.T., Ollendorf, D.A.Effect of initial ziprasidone dose on length of therapy in schizophrenia. Schizophr Res 2006;83:285–292CrossRefGoogle Scholar
Kane, J.M., Khanna, S., Rajadhyaksha, S., Giller, E.Efficacy and tolerability of ziprasidone in patients with treatment-resistant schizophrenia. Int Clin Psychopharmacol 2006;21:21–28CrossRefGoogle ScholarPubMed
Kirschbaum, K.M., Müller, M.J., Malevani, J., Mobascher, A., Burchardt, C., Piel, M.et al.Serum levels of aripiprazole and dehydroaripiprazole, clinical response and side effects. World J Biol Psychiatry 2007;11:1–7Google Scholar
Lieberman, J.A., Stroup, T.S., McEvoy, J.P., Swartz, M.S., Rosenheck, R.A., Perkins, D.O.et al.Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:1209–1223CrossRefGoogle ScholarPubMed
Lingjaerde, O., Ahlfors, U.G., Bech, P., Dencker, S.J., Elgen, K.The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand 1987;334:1–100CrossRefGoogle Scholar
Mamo, D., Kapur, S., Shammi, C.M., Papatheodorou, G., Mann, S., Therrien, F.et al.A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone. Am J Psychiatry 2004;161:818–825CrossRefGoogle ScholarPubMed
Mauri, M.C., Colasanti, A., Rossattini, M., Volonteri, L.S., Dragogna, F., Fiorentini, A.et al.Ziprasidone outcome and tolerability: a practical clinical trial with plasma drug levels. Pharmacopsychiatry 2007;40:89–92CrossRefGoogle ScholarPubMed
Mauri, M.C., Volonteri, L.S., Colasanti, A., Fiorentini, A., De Gaspari, I.F., Bareggi, S.R.Clinical pharmacokinetics of atypical antipsychotics: a critical review of the relationship between plasma concentrations and clinical response. Clin Pharmacokinet 2007;46:359–388CrossRefGoogle ScholarPubMed
Miceli, J.J., Anziano, R.J., Robarge, L., Hansen, R.A., Laurent, A.The effect of carbamazepine on the steady-state pharmacokinetics of Ziprasidone in healthy volunteers. Br J Clin Pharmacol 2000;49(Suppl. 1):65S–70SCrossRefGoogle ScholarPubMed
Miceli, J.J., Glue, P., Alderman, J., Wilner, K.The effect of food on the absorption of oral ziprasidone. Psychopharmacol Bull 2007;40:58–68Google ScholarPubMed
Miceli, J.J., Wilner, K.D., Hansen, R.A., Johnson, A.C., Apseloff, G., Gerber, N.Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers. Br J Clin Pharmacol 2000;49(Suppl. 1):5S–13SCrossRefGoogle ScholarPubMed
Müller, M.J., Regenbogen, B., Härtter, S., Eich, F.X., Hiemke, C.Therapeutic drug monitoring for optimizing amisulpride therapy in patients with schizophrenia. J Psychiatr Res 2007;41(8):673–679CrossRefGoogle ScholarPubMed
National Institute of Mental Health 12-CGI. Clinical global impressionsGuy, W.EDCEU assessment in psychopharmacology 1970; 217–222 Revised ed. Rockville, MarylandGoogle Scholar
Rosenfield, P.J., Girgis, R.R., Gil, R.High-dose ziprasidone-induced acute dystonia. Prog Neuropsychopharmacol Biol Psychiatry 2007;31:546–547CrossRefGoogle ScholarPubMed
Sachse, J., Härtter, S., Hiemke, C.Automated determination of ziprasidone by HPLC with column switching and spectrophotometric detection. Ther Drug Monit 2005;27:158–162CrossRefGoogle ScholarPubMed
Stahl, S.M., Shayegan, D.K.The psychopharmacology of ziprasidone: receptor-binding properties and real-world psychiatric practice. J Clin Psychiatry 2003;64(Suppl. 19):6–12Google ScholarPubMed
Valenstein, M., Blow, F.C., Copeland, L.A., McCarthy, J.F., Zeber, J.E., Gillon, L.et al.Poor antipsychotic adherence among patients with schizophrenia: medication and patient factors. Schizophr Bull 2004;30:255–264CrossRefGoogle ScholarPubMed
Vernaleken I, Fellows C, Janouschek H, Bröcheler A, Veselinovic T, Landvogt C, et al. Striatal and extrastriatal D2/3 receptor binding properties of ziprasidone: a PET study with [18F]fallypride and [11C] raclopride. J Clin Psychopharmacol; in press.Google Scholar
Weiden, P.J., Kozma, C., Grogg, A., Locklear, J.Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv 2004;55:886–891CrossRefGoogle ScholarPubMed
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