Duloxetine in the Treatment of Major Depressive Disorder: Comparisons of Safety and Efficacy in U.S. Hispanic and Majority Caucasian Patients
Roberto Lewis-Fernández, MD; Carlos Blanco, MD, PhD; Craig H. Mallinckrodt, PhD; Madelaine M. Wohlreich, MD; John G. Watkin, DPhil; and John M. Plewes, MD
J Clin Psychiatry 2006;67(9):1379-1390
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: To evaluate new
pharmacotherapies for the treatment of major depressive
disorder (MDD) in Hispanic Americans, the largest
ethnic minority group in the United States.
Method: Efficacy and safety data were
pooled from 7 double-blind, placebo-controlled
clinical trials of duloxetine conducted from
February 1999 through November 2002.
English-speaking patients (aged >= 18 years) meeting
DSM-IV criteria for MDD received duloxetine
(40-120 mg/day; Hispanic, N = 58; Caucasian, N =
748) or placebo (Hispanic, N = 62; Caucasian, N = 594) for up to 9 weeks. Efficacy measures
included the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score,
HAM-D-17 subscales, the Clinical Global
Impressions-Severity of Illness scale, the Patient Global
Impression of Improvement scale, and the Visual
Analog Scales for pain. Safety was assessed using
discontinuation rates, treatment-emergent adverse events, vital signs, and laboratory analyses.
Three sets of data were analyzed using different
pooling strategies, including exploratory analyses
with 470 subjects (Hispanic, N = 51; Caucasian, N
= 419) receiving the recommended dose of 60 mg.
Results: No evidence for a differential
effect of duloxetine in Hispanic and Caucasian
patients was found in efficacy outcomes.
Discontinuation rates due to adverse events among
duloxetine-treated patients were 14.0% for Hispanics
and 17.0% for Caucasians, compared with 3.2% and 5.7%, respectively, for placebo-treated patients
(p = .671). The type of adverse events and their
individual rate of occurrence did not differ
significantly between Hispanic and Caucasian
patients. Mean changes from baseline for pulse,
blood pressure, weight, and laboratory analytes
were small and showed no significant differences
between Hispanic and Caucasian patients.
Conclusion: In this analysis of pooled data,
no evidence for a differential effect of duloxetine
in Hispanic and majority Caucasian patients was found in efficacy or safety outcomes.