Posted by djmmm on October 1, 2003, at 17:14:23
New Compound Demonstrates Efficacy in Treating Anxiety
NEW YORK (Reuters Health) Sept 19 - At a daily dose of 60 mg or higher, Eli Lilly's investigational compound duloxetine yielded a statistically significant reduction in the anxiety symptoms associated with depression, according to a secondary analysis of four clinical studies published in the journal Depression and Anxiety.
The secondary analysis published in the journal was drawn from four double-blind, placebo-controlled studies that evaluated patients with major depressive disorder (MDD). Two of the studies compared treatment with duloxetine exclusively to a placebo group, a third included an arm treated with fluoxetine and the fourth included a paroxetine-treated group.
Investigators compared duloxetine at 60 mg/day or higher to the placebo groups according to 10 measures of the Hamilton anxiety and depression scales, and to 6 outcomes with either paroxetine or fluoxetine.
Duloxetine demonstrated significantly greater mean improvement in 8 of the 10 outcomes in the placebo-based trials. When compared to the two approved anti-depressants, patients treated with duloxetine experienced significantly greater improvement in 3 of 6 outcomes.
In all of the outcome measures, the mean improvement with duloxetine was equal to or greater than active drug.
"Because most anti-depressants succeed in treating anxiety disorders, it would be difficult for the [duloxetine] data to be statistically significant in all outcomes," said Dr. Michael Detke, associate medical director at Eli Lilly and an author of the paper. "These results show the potential of duloxetine to treat anxiety."
The placebo-comparison studies, which included a total of 500 patients, lasted 9 weeks. In the fluoxetine study, 33 patients received 20 mg per day of fluoxetine, 68 received 120 mg per day of duloxetine and 66 received placebo for eight weeks.
Duloxetine was decreased to 40 mg per day in 86 patients in one arm of the 8-week paroxetine study. Another arm with 86 patients received duloxetine at 80 mg per day, with 87 receiving 20 mg of paroxetine and 89 patients on placebo.
The authors noted patients treated with duloxetine exhibited significant improvement as early as week 1 in one study. The improvements subsequently were sustained throughout duration of treatment. Patients treated with duloxetine also did not experience treatment emergent anxiety at a higher rate than those taking placebo.
Treated patients endured adverse events such as nausea, dry mouth, constipation, decreased appetite, and fatigue. Nausea was the only adverse event cited as a reason to discontinue participation in the studies.
Lilly is also seeking approval for duloxetine, which is an inhibitor of the reuptake of both serotonin and norepinephrine, as a treatment for stress urinary incontinence (SUI). The estimated dosing schedule for SUI would be 40 mg, two times per day.
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