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

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.

An Inter-Ethnic Comparison Study of Ziprasidone Plasma Levels, Dosage and Clinical Response in Patients with Schizophrenia

“…This is consistent with previous studies that have demonstrated the clinical efficacy of the drug in Caucasians, African Americans and Asians 202444. Our study confirmed that ziprasidone treatment was associated with fewer adverse effects, including risks for metabolic syndrome, such as higher FBG and lipid levels 45.…”

“…One recent paper studied the efficacy and tolerability of fixed dose ziprasidone in placebo-controlled trials and concluded that the efficacy and safety profiles were similar in African-American and white schizophrenic patients 24. To the best of our knowledge, no published data are available for comparing the plasma concentrations and metabolic effects across different ethnicities (either major, such as Asian vs. Caucasian, or minor, such as Han vs. Mongolian).…”

Persistence of racial disparities in prescription of first-generation antipsychotics in the USA

“…There is some evidence that racial disparities in prescribing FGA may be more pronounced in community‐based settings than in hospital settings . Persistence of racial disparities in use of FGA 30 years after the introduction of second‐generation antipsychotics (SGA) needs to be viewed in the context of current efficacy and side‐effect data for these two classes of antipsychotic medication . The newer SGA (e.g., aripiprazole, olanzapine, and quetiapine) have a broader array of Food and Drug Administration (FDA)‐approved indications, including use in treatment of depression, mania, and irritability due to autism.…”

Comparison of Outcomes for African Americans, Hispanics, and Non-Hispanic Whites in the CATIE Study

“…Lawson and colleagues (2) reported worse scores on akathisia and parkinsonism (but not tardive dyskinesia) for nonHispanic whites but not for African Americans on haloperidol compared with placebo. For ziprasidone, significant increases in akathisia and parkinsonism occurred for African Americans but not for non-Hispanic whites (2).…”

“…Two studies of African Americans, one a review of four double-blind studies (2) and the other an analysis of data from the Texas Medication Algorithm Project (TMAP) on algorithm-guided care (3), found no outcome differences from non-Hispanic whites on a variety of medications. Dosing studies report that similar levels (4) or higher doses (5) of antipsychotics are prescribed to African Americans.…”