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Ziprasidone in Black Patients with Schizophrenia: Analysis of Four Short-term, Double-blind Studies

Published online by Cambridge University Press:  07 November 2014

Abstract

Objective: To better understand the efficacy and tolerability of atypical antipsychotics among racial groups, we reviewed data from four short-term (4–6 weeks), fixed-dose, placebo-controlled trials of ziprasidone for black, white, and overall populations of patients with schizophrenia.

Methods: Efficacy of ziprasidone in the black, white, and overall schizophrenic populations was compared to placebo using standard efficacy measures (Positive and Negative Syndrome Scale [PANSS] total, PANSS negative, Brief Psychiatric Rating Scale [BPRS], Clinical Global Impression-Severity [CGI-S], CGI-Improvement [CGI-I]).

Results: Black patients receiving ziprasidone demonstrated statistically significant improvements from baseline in PANSS total, PANSS negative, and BPRS, and improvements in CGI-S and CGI-I (n=99–149) compared with placebo (n=41–66); improvements were comparable to those observed in the overall population (n=451–639) and the white population (n=310–430). Interaction effect (treatment by race) was not significant for any efficacy variables. Ziprasidone was well-tolerated among black patients (n=175). Adjusted mean (least squares mean) overall weight gain in black patients receiving ziprasidone (n=124) was 1.8 kg. There were no increases in total cholesterol, triglycerides, or random glucose in the black population.

Conclusion: Ziprasidone has similar efficacy and safety in black patients with schizophrenia compared with patients in the white and overall populations.

Type
Original Research
Copyright
Copyright © Cambridge University Press 2009

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References

REFERENCES

1.U.S.Department of Health and Human Services. Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials. Food and Drug Administration. Available at: http://www.fda.gov/cber/gdlns/racethclin.htm. Accessed December 11, 2008.Google Scholar
2.Kreyenbuhl, J, Zito, JM, Buchanan, RW, Soeken, KL, Lehman, AF. Racial disparity in the pharmacological management of schizophrenia. Schizophr Bull. 2003;29:183193.CrossRefGoogle ScholarPubMed
3.Lawson, WB. Racial and ethnic factors in psychiatric research. Hosp Community Psychiatry. 1986;37:5054.Google Scholar
4.Ruiz, P, Varner, RV, Small, DR, Johnson, BA. Ethnic differences in the neuroleptic treatment of schizophrenia. Psychiatr Q. 1999;70:163172.Google Scholar
5.Strickland, TL, Ranganath, V, Lin, KM, Poland, RE, Mendoza, R, Smith, MW. Psychopharmacologic considerations in the treatment of black American populations. Psychopharmacol Bull. 1991;27:441448.Google ScholarPubMed
6.Emsley, RA, Roberts, MC, Rataemane, S, et al.Ethnicity and treatment response in schizophrenia: a comparison of 3 ethnic groups. J Clin Psychiatry. 2002;63:914.Google Scholar
7.Lin, KM, Finder, E. Neuroleptic dosage for Asians. Am J Psychiatry. 1983;140:490491.Google ScholarPubMed
8.Perkins, DO, Gu, H, Weiden, PJ, McEvoy, JP, Hamer, RM, Lieberman, JA. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry. 2008;69:106113.CrossRefGoogle ScholarPubMed
9.Frackiewicz, EJ, Sramek, JJ, Herrera, JM, Kurtz, NM, Cutler, NR. Ethnicity and antipsychotic response. Ann Pharmacother. 1997;31:13601369.Google Scholar
10.McMahon, FJ, Buervenich, S, Charney, D, et al.Variation in the gene encoding the serotonin 2A receptor is associated with outcome of antidepressant treatment. Am J Hum Genet. 2006;78:804814.Google Scholar
11.Glazer, WM, Morgenstern, H, Doucette, J. Race and tardive dyskinesia among outpatients at a CMHC. Hosp Community Psychiatry. 1994;45:3842.Google Scholar
12.Jeste, DV, Caligiuri, MP, Paulsen, JS, et al.Risk of tardive dyskinesia in older patients. A prospective longitudinal study of 266 outpatients. Arch Gen Psychiatry. 1995;52:756765.CrossRefGoogle ScholarPubMed
13.Morgenstern, H, Glazer, WM. Identifying risk factors for tardive dyskinesia among long-term outpatients maintained with neuroleptic medications. Results of the Yale Tardive Dyskinesia Study. Arch Gen Psychiatry. 1993;50:723733.CrossRefGoogle ScholarPubMed
14.Tran, PV, Lawson, WB, Andersen, S, Shavers, E. Treatment of the African-American patient with novel antipsychotic agents. In: Herrera, JM, Lawson, WB, Sramek, JJ, eds. Cross Cultural Psychiatry. 1st ed. Sussex, UK: John Wiley & Sons; 1999:131138.Google Scholar
15.Copeland, LA, Zeber, JE, Valenstein, M, Blow, FC. Racial disparity in the use of atypical antipsychotic medications among veterans. Am J Psychiatry. 2003;160:18171822.Google Scholar
16.Kelly, DL, Kreyenbuhl, J, Dixon, L, Love, RC, Medoff, D, Conley, RR. Clozapine underutilization and discontinuation in African Americans due to leucopenia. Schizophr Bull. 2007;33:12211224.Google Scholar
17.Daumit, GL, Crum, RM, Guallar, E, et al.Outpatient prescriptions for atypical antipsychotics for African Americans, Hispanics, and whites in the United States. Arch Gen Psychiatry. 2003;60:121128.Google Scholar
18.Herbeck, DM, West, JC, Ruditis, I, et al.Variations in use of second-generation antipsychotic medication by race among adult psychiatric patients. Psychiatr Serv. 2004;55:677684.CrossRefGoogle ScholarPubMed
19.Kuno, E, Rothbard, AB. Racial disparities in antipsychotic prescription patterns for patients with schizophrenia. Am J Psychiatry. 2002;159:567572.Google Scholar
20.Lawson, WB. Clinical issues in the pharmacotherapy of African-Americans. Psychopharmacol Bull. 1996;32:275281.Google ScholarPubMed
21.Mark, TL, Dirani, R, Slade, E, Russo, PA. Access to new medications to treat schizophrenia. J Behav Health Serv Res. 2002;29:1529.CrossRefGoogle ScholarPubMed
22.Melfi, CA, Croghan, TW, Hanna, MP, Robinson, RL. Racial variation in antidepressant treatment in a Medicaid population. J Clin Psychiatry. 2000;61:1621.Google Scholar
23.Opolka, JL, Rascati, KL, Brown, CM, Gibson, PJ. Ethnicity and prescription patterns for haloperidol, risperidone, and olanzapine. Psychiatr Serv. 2004;55:151156.Google Scholar
24.Van Dorn, RA, Swanson, JW, Swartz, MS, Elbogen, EB. The effects of race and criminal justice involvement on access to atypical antipsychotic medications among persons with schizophrenia. Ment Health Serv Res. 2005;7:123134.CrossRefGoogle ScholarPubMed
25.Walkup, JT, McAlpine, DD, Olfson, M, Labay, LE, Boyer, C, Hansell, S. Patients with schizophrenia at risk for excessive antipsychotic dosing. J Clin Psychiatry. 2000;61:344348.Google Scholar
26.Segal, SP, Bola, JR, Watson, MA. Race, quality of care, and antipsychotic prescribing practices in psychiatric emergency services. Psychiatr Serv. 1996;47:282286.Google ScholarPubMed
27.Whaley, AL. Racism in the provision of mental health services: a social-cognitive analysis. Am J Orthopsychiatry. 1998;68:4757.CrossRefGoogle ScholarPubMed
28.Keck, P Jr., Buffenstein, A, Ferguson, J, et al.Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo-controlled trial. Psychopharmacology (Berl). 1998;140:173184.CrossRefGoogle ScholarPubMed
29.Daniel, DG, Zimbroff, DL, Potkin, SG, Reeves, KR, Harrigan, EP, Lakshminarayanan, M. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone Study Group. Neuropsychopharmacology. 1999;20:491505.Google Scholar
30.Rappard, F, Vanderburg, D, Warrington, L, Yang, R. Ziprasidone in hospitalized patients with schizophrenia: evidence for rapid dose titration [abstract]. Schizophr Bull. 2007;33:455.Google Scholar
31.Ciliberto, N, Bossie, CA, Urioste, R, Lasser, RA. Lack of impact of race on the efficacy and safety of long-acting risperidone versus placebo in patients with schizophrenia or schizoaffective disorder. Int Clin Psychopharmacol. 2005;20:207212.Google Scholar
32.Roberts, H, Warrington, L, Yang, R. Ziprasidone in the treatment of schizophrenia: evidence for a linear dose-response relationship [abstract]. Schizophr Bull. 2007;33:477.Google Scholar
33.Folks, DG, Lombardo, I, Loebel, AD, Yang, R. Effect of ziprasidone on weight and metabolic parameters at various fixed doses in patients with schizophrenia or schizoaffective disorder. Presented at: American Psychiatric Association Annual Meeting; May 19-24, 2007; San Diego, CA. Poster NR512.Google Scholar
34.Lieberman, JA, Stroup, TS, McEvoy, JP, et al.Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:12091223.CrossRefGoogle ScholarPubMed