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Relationship between African–American or Caucasian origin and outcomes in the olanzapine treatment of acute mania: a pooled analysis of three adult studies conducted in the United States of America

Degenhardt, Elisabeth K.a; Tamayo, Jorge M.b; Jamal, Hassan H.a; Gatz, Jennifera; Tohen, Mauricioc; Durell, Todd M.a

International Clinical Psychopharmacology: May 2011 - Volume 26 - Issue 3 - p 141–145
doi: 10.1097/YIC.0b013e32834228af
Original Articles

The aim of this study was to explore the role of ethnic origin in the treatment of acute bipolar mania. Treatment outcomes were studied in a post-hoc analysis of African–American (AA, n=41) and Caucasian (CA, n=190) adults treated with olanzapine in three studies conducted in the United States of America. Baseline demographics were similar except that the AA cohort had fewer women compared with the CA cohort (37 vs. 58%; P=0.01). Daily mean modal olanzapine dose and study discontinuation rate for AA and CA were: 16.2 mg vs. 16.6 mg and 41.5 vs. 25.3% (P=0.03), respectively. There were four (23.5% of discontinuers) and 19 (39.6% of discontinuers, P=0.14) discontinuations because of a poor response in the AA and CA groups, respectively. Drug exposure for the AA cohort was 18.7 days and that of the CA cohort was 19.3 days. Both cohorts showed similar symptom improvements, and safety outcomes were not statistically significantly different except for the following treatment-emergent adverse event frequencies for AA and CA cohorts, respectively: agitation (24.4 vs. 10.5%, P=0.04); dysmenorrhoea (20.0 vs. 3.6%, P=0.04); and dizziness postural (7.3 vs. 1.1%, P=0.04). Although study findings [limited by a smaller (18% of total population) AA cohort] need replication, they suggest that while many outcomes were similar in both cohorts, clinicians could benefit from the awareness of factors in the AA population that possibly influence study discontinuation rates, treatment-emergent adverse event reporting, and participation by sex.

aLilly USA, LLC, Indianapolis, Indiana

bCES University, Medellín, Colombia

cUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas, USA

Correspondence to Elisabeth K. Degenhardt, RN, MSN, Drop Code 4133, Lilly USA, LLC, Indianapolis, IN 46285, USA Tel: +1 317 433 3755; fax: +1 317 276 7100; e-mail: degenhardt@lilly.com

Received May 26, 2010

Accepted November 1, 2010

© 2011 Lippincott Williams & Wilkins, Inc.