A Randomized Evaluation of the Effects of Six Antipsychotic Agents on QTc, In the Absence and Presence of Metabolic Inhibition

Journal of Clinical Psychopharmacology

Volumn 24, Issue 1, 2004, Pages 62-69

  Harrigan, Edmund P ^a   Miceli, Jeffrey J ^a,d   Anziano, Richard ^a   Watsky, Eric ^a   Reeves, Karen R ^a   Cutler, Neal R ^b   Sramek, John ^b   Shiovitz, Thomas ^b   Middle, Michelle ^c  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b Ingenix Inc   (United States)

^c South Africa Clinical Trials Ltd   (South Africa)

^d PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BENZATROPINE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CISAPRIDE; CYTOCHROME P450 1A2; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOCHROME P450 INHIBITOR; DRUG METABOLITE; FLUOXETINE; FLUVOXAMINE; HALOPERIDOL; KETOCONAZOLE; LITHIUM; LORAZEPAM; NEUROLEPTIC AGENT; OLANZAPINE; PAROXETINE; PLACEBO; QUETIAPINE; RISPERIDONE; TERFENADINE; THIORIDAZINE; UNINDEXED DRUG; ZIPRASIDONE; ZOLPIDEM;

ADULT; AGITATION; ARTICLE; BLOOD SAMPLING; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG FATALITY; DRUG METABOLISM; DRUG SCREENING; ELECTROCARDIOGRAM; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HEART ARRHYTHMIA; HEART RATE; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; METABOLIC INHIBITION; MONOTHERAPY; MOTOR DYSFUNCTION; OPEN STUDY; PHARMACOKINETICS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSYCHOSIS; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SEIZURE; STEADY STATE; SYNCOPE; TORSADE DES POINTES;

ADOLESCENT; ADULT; ANTIPSYCHOTIC AGENTS; ARYL HYDROCARBON HYDROXYLASES; BENZODIAZEPINES; BIOTRANSFORMATION; CLOZAPINE; DIBENZOTHIAZEPINES; ELECTROCARDIOGRAPHY; FEMALE; HALOPERIDOL; HEART CONDUCTION SYSTEM; HUMANS; LONG QT SYNDROME; MALE; MIDDLE AGED; RISPERIDONE; THIORIDAZINE;

EID: 1642579574     PISSN: 02710749     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.jcp.0000104913.75206.62     Document Type: Article

References (51)

1. Yap YG, Camm J. Risk of torsade de pointes with non-cardiac drugs. Br Med J. 2000;320:1158-1159.
2. Crumb W, Beasley CM, Breier AF, et al. Effect of olanzapine and other antipsychotics on human cardiac ion channel blocking. Presented at the American Psychiatric Association Congress, May 16, 2000: NR338.
3. Czekalla J, Beasley CM Jr, Dellva MA, et al. Analysis of the QTc interval during olanzapine treatment of patients with schizophrenia and related psychosis. J Clin Psychiatry. 2001;62(3):191-198.
4. Food and Drug Administration. Psychopharmacological Drugs Advisory Committee Briefing Document for Ziprasidone HCl Capsules. NDA 20-825; July 19, 2000.
5. Agelink MW, Majewski T, Wurthmann C, et al. Effects of newer atypical antipsychotics on autonomic neurocardiac function: a comparison between amisulpride, olanzapine, sertindole, and clozapine. J Clin Psychopharmacol. 2001;21(1):8-13.
6. Tran PV, Hamilton SH, Kuntz AJ, et al. Double-blind comparison of olanzapine versus risperidone in the treatment of schizophrenia and other psychotic disorders. J Clin Psychopharmacol. 1997;17(5):407-418.
7. Litherland S. Drug treatment and schizophrenia in the 1990s. Drugs. 1997;54(5):794.
8. Kasper S, Hale A, Azorin JM, et al. Benefit-risk evaluation of olanzapine, risperidone and sertindole in the treatment of schizophrenia. Eur Arch Psychiatry Clin Neurosci. 1999;249(Suppl 2):II1-II14.
9. Gury C, Canceil O, Iaria P. Antipsychotic drugs and cardiovascular safety: current studies of prolonged QT interval and risk of ventricular arrhythmia. Encephale. 2000;26(6):62-72.
10. Cavero I, Mestre M, Guillon JM, et al. Drugs that prolong QT interval as an unwanted effect: assessing their likelihood of inducing hazardous cardiac dysrhythmias. Exp Opin Pharmacother. 2000;1(5): 947-973.
11. Bednar MM, Harrigan EP, Anziano RJ, et al. The QT interval. Prog Cardiovasc Dis. 2001;43(5, pt 2):1-45.
12. Morganroth J, Brozovich FV, McDonald JT, et al. Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiology. 1991;67(8):774-776.
13. Adamson H, Jacobs A, Warrington S. Normal values for electrocardiogram intervals in healthy young subjects. Int J Pharm Med. 1998;12:289-291.
14. Viskin S. Long QT syndromes and torsades de pointes. Lancet. 1999; 354:1625-1633.
15. Miceli JJ, Smith M, Robarge L, et al. The effects of ketoconazole on ziprasidone pharmacokinetics-a placebo-controlled crossover study in healthy volunteers. Br J Clin Pharmacol. 2000;49(Suppl 1):71S-76S.
16. Prior TI, Baker GB. Interactions between the cytochrome P450 system and the second-generation antipsychotics. J Psychiatry Neurosci. 2003; 28(2):99-112.
17. Blake BL, Rose RL, Mailman RB, Levi PE, et al. Metabolism of thioridazine by microsomal monooxygenases: relative roles of P450 and flavin-containing monooxygenase. Xenobiotica. 1995;25(4):377-393.
18. Fang J, Baker GB, Silverstone PH, et al. Involvement of CYP3A4 and CYP2D6 in the metabolism of haloperidol. Cell Mol Neurobiol. 1997; 17(2):227-233.
19. Magliozzi JR, Hollister LE. Elimination half-life and bioavailability of haloperidol in schizophrenic patients. J Clin Psychiatry. 1985;46(1): 20-21.
20. Ng CH, Crammer JL. Measurement of thioridazine in blood and urine. Br J Clin Pharmacol. 1977;4(2):173-183.
21. Tandon R. Introduction. Ziprasidone appears to offer important therapeutic and tolerability advantages over conventional, and some novel, antipsychotics. Br J Clin Pharmacol. 2000;49(Suppl 1):1S-3S.
22. Risperdal (risperidone tablets/oral solution). Physicians' Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company; 2000: 1435-1457 (USPI).
23. Seroquel (quetiapine fumarate). Physicians' Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company; 2000:562-566 (USPI).
24. Zyprexa (olanzapine). Physicians' Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company; 2000:1649-1653 (USPI).
25. Chakraborty BS, Midha KK, McKay G, et al. Single dose kinetics of thioridazine and its two psychoactive metabolites in healthy humans: a dose proportionality study. J Pharm Sci. 1989;78(10):796-801.
26. Hartigan-Go K, Bateman DN, Nyberg G, et al. Concentration-related pharmacodynamic effects of thioridazine and its metabolites in humans. Clin Pharmacol Ther. 1996;60(5):543-553.
27. Forsman, A, Ohman, R. Pharmacokinetic studies on haloperidol in man. Curr Ther Res. 1976;20(3):319-336.
28. Janiszewski JS, Fouda HG, Cole RO. Development and validation of a high-sensitivity assay for an antipsychotic agent, CP-88,059, with solid-phase extraction and narrow-bore high-performance liquid chromatography. J Chromatogr B Biomed Appl. 1995 9;668(1):133-139.
29. Grant S, Fitton A. Risperidone, a review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs. 1994; 48(2):253-273.
30. Food and Drug Administration. Zyprexa (olanzapine) FDA Review Documents. Summary Basis of Approval. NDA 20-592; 1996.
31. Thyrum PT, Fabre LF, Wong YWJ, et al. Multiple dose pharmacokinetics of (Quetiapine) ICI 204,636 in schizophrenic men and women. Psychopharmacol Bull. 1996;32(3):525.
32. Thyrum PT, Jaskiw G, Fuller M, et al. Multiple dose pharmacokinetic of ICI 204,636 in elderly patients with selected psychotic disorders. Psychopharmacol Bull. 1996;32(3):524.
33. Food and Drug Administration. Seroquel (Quetiapine) FDA Review Documents. Summary Basis of Approval. NDA 20-639; 1997.
34. Palao DJ, Arauxo A, Brunet M, et al. Haloperidol: therapeutic window in schizophrenia. J Clin Psychopharmacol. 1994;14(5):303-310.
35. Morselli PL, Bianchetti G, Dugas M. Haloperidol plasma level monitoring in neuropsychiatric patients. Ther Drug Monit. 1982;4(1): 51-58.
36. Hardman JG, Gilman AG, Limbird LE, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York: McGraw-Hill; 1996:1747.
37. Van Harten, J. Clinical pharmacokinetics of selective serotonin reuptake inhibitors. Clin Pharmacokinet. 1993;24(3):203-220.
38. Heel RC, Brogden RN, Carmine A, et al. Ketoconazole: a review of its therapeutic efficacy in superficial and systemic fungal infections. Drugs. 1982;23(1-2):1-36.
39. Varhe A, Olkkola KT, Neuvonen PJ. Oral triazolam is potentially hazardous to patients receiving systemic antimycotics ketoconazole or itraconazole. Clin Pharmacol Ther. 1994;56(6, pt 1):601-607.
40. DeVane CL, Gill HS. Clinical pharmacokinetics of fluvoxamine: applications to dosage regimen design. J Clin Psychiatry. 1997;58 (Suppl 5):7-14.
41. Vandel S, Bertschy G, Baumann P, et al. Fluvoxamine and fluoxetine: interaction studies with amitriptyline, clomipramine and neuroleptics in phenotyped patients. Pharmacol Res. 1995;31(6):347-353.
42. Kaye CM, Haddock RE, Langley PF, et al. A review of the metabolism and pharmacokinetics of paroxetine in man. Acta Psychiatr Scand Suppl. 1989;350:60-75.
43. Timell AM. Thioridazine: re-evaluating the risk/benefit equation. Ann Clin Psychiatry. 2000;12(3):147-151.
44. Honig PK, Wortham DC, Zamani K, et al. Terfenadine-ketoconazole interaction. Pharmacokinetic and electrocardiographic consequences. J Am Med Assoc. 1993;269(12):1513-1518.
45. Estelle F, Simons R. H1-receptor antagonists: safety issues. Ann Allergy Asthma Immunol. 1999;83(5):481-488.
46. Woosley RL, Chen Y, Freiman J, et al. Mechanism of the cardiotoxic actions of terfenadine. J Am Med Assoc. 1993;269(12):1532-1536.
47. Committee for Proprietary Medicinal Products (CPMP). Opinion of the CPMP Pursuant to Article 12 of Council Directive 75/319/EEC as Amendedfor Terfenadine. CPMPO/1000/97-EN; May 1997.
48. Laine K, Forsstrom J, Gronroos P, et al. Frequency and clinical outcome of potentially harmful drug metabolic interactions in patients hospitalized on internal and pulmonary medicine wards: focus on warfarin and cisapride. Ther Drug Monit. 2000;22(5):503-509.
49. Vitola J, Vukanovic J, Roden DM. Cisapride-induced torsades de pointes. J Cardiovasc Electrophysiol. 1998;9(10): 1109-1113.
50. Beedham C, Obach RS, Miceli J. Ziprasidone metabolism, aldehyde oxidase and clinical implications. J Clin Psychopharmacol. 2003;23(3): 229-232.
51. Glassman AH. Clinical management of cardiovascular risks during treatment with psychotropic drugs. J Clin Psychiatry. 2002;63(Suppl 9): 12-17.