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| |  CINP: Tiagabine Effective for Treatment of Anxiety in Patients With Inadequate Response to Selective Serotonin Reuptake Inhibitors By Jill Stein PARIS, FRANCE -- June 21, 2004 -- Tiagabine may provide effective augmentation therapy in patients with generalized anxiety disorder who are partial responders to selective serotonin reuptake inhibitor (SSRI) therapy, researchers reported here on June 21st at the at the XXIV Collegium Internationale Neuro-psychopharmacologicum Congress. Tiagabine selectively inhibits gamma-aminobutyric acid (GABA) reuptake and the GAT-1 GABA transporter, thus increasing its synaptic GABA availability. Arif Khan, MD, Medical Director, Northwest Clinical Research Center, Bellevue, Washington, reported the results of an open-label trial that evaluated tiagabine as augmentation therapy in 48 patients with generalized anxiety disorder who had a partial response to SSRI monotherapy and remained symptomatic after at least 6 weeks of treatment. The researchers defined partial response as less than 50% decrease in symptoms reported by the physician or patient, or by physician rating on the Hamilton Rating Scale for Anxiety (HAM-A) or the anxiety subscale score on the Hospital Anxiety and Depression Scale (HADS). They defined responders as patients who had a 50% or greater reduction in HAM-A total score. Remission was defined as HAM-A total score of 7 or less. An adequate SSRI regimen was defined as 6 weeks or more of SSRI monotherapy at an adequate but at least minimally therapeutic dose, with 4 weeks or more at a stable dose. Patients had a total score on the HAM-A of 16 or greater, and HADS anxiety subscale score of 7 or greater, and a Clinical Global Impression (CGI) of severity score of 4 or greater. Tiagabine was started at 4 mg/day and individually titrated weekly by 4 mg increments up to a maximum dose of 16 mg/day. The SSRI dose was fixed throughout the 8-week study. Results among 36 patients who completed the treatment phase of the study showed that tiagabine reduced anxiety symptoms, as evidenced by significant changes from baseline in mean HAM-A total score at week 1, with the effect maintained through week 8. Overall, 52% of 48 patients were considered responders, and 35% of patients achieved remission at the final visit. Similar results were observed on the patient-rated HADS. Fifty-six percent of patients were rated as "much improved" or "very much improved" with respect to overall clinical condition as assessed by CGI of improvement at final visit. Tiagabine improved subjective reports of sleep quality, as shown by a significant reduction from baseline in mean Pittsburgh Sleep Quality Index global score. It also improved functional status, as shown by a significant reduction from baseline in mean Sheehan Disability Scale total score. The agent was generally well tolerated. Most commonly reported adverse events were somnolence, seen in 12 patients, and dizziness seen in 11 patients. Eight percent of patients discontinued treatment because of adverse events. "While SSRIs are commonly used medications for [generalized anxiety disorder], up to 45% of [patients] who are treated with SSRIs do not achieve a response, and up to 65% do not achieve remission," Dr. Khan said. "We believe the study demonstrates that tiagabine may help enhance response in patients who partially respond to the SSRIs." The study was sponsored by Cephalon, Inc. in West Chester, Pennsylvania.
[Presentation title: "Tiagabine as SSRI Augmentation Therapy in Patients With Generalized Anxiety Disorder: an Open-Label Study." Abstract #P01.236]
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