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Once-daily duloxetine 60 mg effective treatment for MDD-related anxiety in older patients, study suggests

Wednesday, May 09 2007 | Comments
Evidence Grade 0 What's This?
Duloxetine 60 mg once daily may be effective in treating anxiety symptoms associated with major depressive disorder in older patients, a study demonstrated.

In the double-blind study, researchers randomized 311 patients aged 65 years or older to receive once-daily duloxetine 60 mg (n=207) or placebo (n=104) for 8 weeks after a 1-week placebo lead-in period. Patients met DSM-IV criteria for MDD and had a Hamilton Depression Rating Scale (HAM-D-17) score of >=18.

Efficacy analyses focused on the HAM-D-17 item 10, which measures psychic anxiety; the HAM-D-17 item 11, which measures somatic anxiety; and the HAM-D-17 anxiety somatization subscale. Overall, 78.3% of the patients randomized to receive duloxetine and 76.9% of the patients randomized to receive placebo completed the study.

As compared with placebo, duloxetine was associated with significantly greater reductions in MDD-related anxiety symptoms, as measured using the HAM-D-17 item 10 (mean score change, -0.18 vs -0.62, respectively; P<.001) and the anxiety somatization subscale (mean change, -0.99 vs -1.88, respectively; P=.002). However, the between-group difference in the change in HAM-D-17 item 11 scores was not statistically significant.

Similarly, among patients aged younger than 75 years, duloxetine was associated with significantly greater reductions in MDD-related anxiety relative to placebo, as measured using the HAM-D-17 item 10 (mean change, -0.63 vs -0.17, respectively; P=.002) and the anxiety somatization subscale (mean change, -1.9 vs -0.8, respectively; P=.003).

Among patients aged 75 years or older, the only measure that showed significant improvement in the duloxetine group relative to the placebo group was the HAM-D-17 item 10 (mean change, -0.61 vs 0, respectively; P=.007). Although results from the anxiety somatization subscale seemed to favor duloxetine numerically, the between-group difference was not statistically significant (mean change, -1.92 vs -1.25; P=.312).

Discontinuation rates because of adverse events in the duloxetine and placebo groups were 9.7% and 8.7%, respectively. The most common treatment-emergent adverse events in the duloxetine group were dry mouth (14.5% vs 1.9% in the placebo group; P<.001), nausea (12.6% vs 3.8% in the placebo group; P=.014), and constipation (10.1% vs 4.8% in the placebo group; P=.131). (Russell J, et al. Poster C22.)

This information may concern a use that has not been approved by the Food and Drug Administration.

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