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BACKGROUND: Pooled data from double-blind, placebo-controlled studies were utilized to compare the safety and efficacy of duloxetine in the treatment of major depressive disorder (MDD) in African-American and Caucasian patients. METHODS: Efficacy and safety data were pooled from seven double-blind, placebo-controlled clinical trials of duloxetine. Patients (aged > or =18 years) meeting DSM-IV criteria for MDD received duloxetine (40-120 mg/day; African Americans, N=69; Caucasians, N=748) or placebo (African Americans, N=59; Caucasians, N=594) for up to nine weeks. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score, the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and Visual Analog Scales (VAS) for pain. Safety was assessed using discontinuation rates, spontaneously reported treatment-emergent adverse events, vital signs and laboratory analyses, RESULTS: Based upon mean changes in HAMD17, CGI-S and PGI-I scales, the magnitude of duloxetine's treatment effects did not differ significantly between African-American and Caucasian patients. Discontinuation rates due to adverse events among duloxetine-treated patients were 13.0% for African Americans and 17.0% for Caucasians. No adverse event led to discontinuation in more than one African-American patient. The most common treatment-emergent adverse events in both ethnic groups included nausea, headache, constipation, dizziness and insomnia. The rate of occurrence of these events did not differ significantly between African-American and Caucasian patients. Mean changes from baseline for pulse, blood pressure, weight and laboratory analytes were small and showed no significant differences between African-American and Caucasian patients. CONCLUSION: In this analysis of data from seven clinical trials, no convincing evidence was found to suggest that the overall safety and tolerability profile or the efficacy profile for duloxetine in this cohort of African-American patients differed from that observed in a comparator group of Caucasian patients. The results from these analyses provide supportive evidence for the efficacy and safety of duloxetine in the treatment of MDD in African-American patients.