The current analysis describes efficacy and safety data from depressed African-American patients (n=128) who participated in seven clinical trials of duloxetine 30 mg/day of up to nine weeks duration. Comparisons of treatment effects in these African-American patients with those observed in Caucasian patients (n=1342) found no compelling evidence of differential efficacy or safety profiles between [...]
Continue reading " Duloxetine in the Treatment of Major Depressive Disorder: DISCUSSION "
Discontinuation rates. In analyses of pooled data from all seven studies, the rate of discontinuation due to adverse events among African-American patients (generic duloxetine 13.0% vs. placebo 3.4%) was similar to that observed in Caucasian patients duloxetine 17.0% vs. placebo 5.7%). Other events leading to early study discontinuation among duloxetine-treated patients included loss to follow-up [...]
Continue reading " Duloxetine in the Treatment of Major Depressive Disorder: Safety "
Patient Characteristics
Baseline patient demographics are summarized in Table 2. African-American patients were significantly younger (p=0.001), and had significantly higher mean body weight (p=0.049), when compared with Caucasian patients. There were no significant differences in psychiatric profile at baseline (Table 2). With regard to psychiatric history, African-American patients had a significantly higher mean age at onset [...]
Continue reading " Duloxetine in the Treatment of Major Depressive Disorder: RESULTS "
Data Pooling Strategies
Within the seven studies, 82.7% of patients were Caucasian and 7.9% were African-American. The current analyses therefore utilize 90.6% of the total study population. The remaining patients were primarily of Hispanic origin (7.4%).
Design
All seven studies included in these analyses were randomized, multicenter, double-blind, active comparator- and/or placebo-controlled clinical trials. This represented all available data from U.S.-based, placebo-controlled, clinical trials of duloxetine medication in patients with MDD (data from two additional studies carried out in Eastern Europe were not included, since no African-American patients were enrolled). Key design elements [...]
Continue reading " Duloxetine in the Treatment of Major Depressive Disorder: METHODS Study "
INTRODUCTION
According to census data for the year 2000, 34.7 million U.S. residents (12.3% of the population) listed their ethnicity as black or African-American, making this the second largest minority ethnic group after Hispanics. When compared with the white population, African Americans display an increased prevalence of several medical conditions, including diabetes and hypertension, and are [...]
Major depression is a common and debilitating disorder that affects 10% to 15% of the population each year. Advances in understanding the psychopharmacology of depression has lead to the introduction of several new classes of antidepressant medication in the past decade. Despite these advances, however, patients’ overall response to any given pharmacologic approach continues to [...]
Continue reading " Pharmacologic management of refractory depression "
