Christer Allgulander, MD, associate professor, psychiatry division, Karolinska Institute, Stockholm, Sweden, reported data from a pooled analysis of 3 randomised, double-blind, placebo-controlled trials of the serotononergic noradrenergic reuptake inhibitor (SNRI) duloxetine with a total of 1,163 patients.

Two studies had a 10-week flexible-dose 60 to 120 mg/day regimen, and 1 study had a 9-week fixed-dose 60 or 120 mg/d regimen.

The primary efficacy measure was mean change from baseline to endpoint in Hamilton Anxiety Scale (HAMA) total score. Secondary efficacy measures included HAMA Psychic and Somatic factor score, HAMA response and remission rate, Hospital Anxiety Depression Scale (HADS) subscale score, and Clinician and Patient Global Impressions-Improvement scale.

Response was defined as 50% or greater reduction in HAMA total score from baseline to endpoint, and remission was defined as HAMA total score of 7 or less at endpoint.

Results showed that the intent-to-treat duloxetine-treated patients had a significantly greater mean reduction on the HAMA total score compared with placebo-treated patients (M = -11.1 vs M = -.80, P less than or equal to .001).On all secondary measures, the duloxetine group had significantly greater improvement than the placebo group.

Compared with placebo, duloxetine patients had greater functional improvement as demonstrated by decreases in Sheehan Disability Scale global functioning score (P less than or equal to .001).

Response and remission rates in duloxetine-treated patients (51% and 30%, respectively) were higher than in placebo-treated patients (33% and 20%, respectively (P < .001 for both comparisons).

Overall, 34% of the duloxetine group and 31% of the placebo group dropped out of the study prematurely. Duloxetine-treated patients usually withdrew because of adverse events (P less than or equal to .001), and placebo patients withdrew because of a lack of efficacy (P < .001).

Nausea was the most common treatment-emergent event.

"The results demonstrate that duloxetine is an effective pharmacologic intervention for generalised anxiety disorder," Dr. Allgulander said in a presentation on March 31^st.

The study was sponsored by Lilly Research Laboratories in Indianapolis, Indiana.


[Presentation title: Duloxetine as an Effective Treatment for Adults With Generalized Anxiety Disorder. Abstract P69]

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