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Title: Patients With Anxiety Benefit From Early Addition of Alprazolam to Therapy: Presented at ADAA

"Patients With Anxiety Benefit From Early Addition of Alprazolam to Therapy: Presented at ADAA"

By Jill Stein ST.LOUIS, MO -- April 2, 2007 -- Insomnia and overall wellbeing in patients with generalised anxiety disorder (GAD) improve more quickly with early treatment combining alprazolam orally disintegrating tablets (ODT) in combination with a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine serotonin reuptake inhibitor (SNRI) antidepressants compared with SSRI or SNRI monotherapy. The results were reported here on March 31[^st at the 27^th Annual Meeting of the Anxiety Disorders Association of America (ADAA).

Jeffrey N. DeWester, MD, family physician, DeWester Family Medicine Research and Treatment Center, Indianapolis, Indiana, United States, presented results in 129 patients who were randomised to 8 weeks of open-label treatment with alprazolam ODT combined with a SSRI or SNRI or to monotherapy with a SSRI or SNRI.

"Serotonin reuptake inhibitors are recommended as first-line pharmacotherapies for the treatment of GAD," Dr. DeWester pointed out in his poster presentation. "However, the onset of therapeutic effect with these agents requires several weeks of treatment during which anxiety symptoms and sleep disturbances may worsen."

Adjunctive treatment with a benzodiazepine when initiating SSRI or SNRI therapy may diminish this effect and hasten therapeutic improvement but combination treatment has not been well studied in GAD, he added.

Participants in the trial had a primary diagnosis of GAD without panic disorder.

The primary efficacy variable was time to response where response was defined as a decrease in Hamilton Rating scale for Anxiety (HAM-A) response of at least 50% from baseline.

The 2 treatment groups were similar with respect to baseline demographic and clinical characteristics.

There was no statistically significant difference between the combination and monotherapy treatment groups in terms of the primary efficacy measure in the intent-to-treat population.

Statistically significant differences in HAM-A scores were observed at the second and fourth weeks and on the HAM-A insomnia item at the first and second weeks in favour of the group treated with an SSRI/SNRI plus alprazolam ODT versus SSRI/SNRI alone (P < .05).

Both investigator-rated and subject-rated global improvement measures favoured combination treatment with SSRI/SNRI plus alprazolam ODT over SSRI/SNRI alone at certain early time points.

Both treatment regiments were generally well tolerated. Only 1 patient in each group dropped out of the study prematurely because of adverse effects.

Overall, the results demonstrate that combination treatment provides important benefits over serotonin reuptake inhibitors alone in patients with GAD, Dr. DeWester said.

The study was sponsored by Schwarz Pharma.

[Presentation title: Early Treatment of Generalized Anxiety Disorder With Alprazolam Orally Disintegrating Tablets in Combination With SSRI or SNRI Antidepressants: Results from a Randomized, Naturalistic Trial. Abstract P68]

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