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Pregabalin Facilitates Successful Switch From Benzodiazepine Therapy in Patients With Generalised Anxiety Disorder: Presented at ECNP

By Jenny Powers

ISTANBUL, Turkey -- September 18, 2009 -- Patients with generalised anxiety disorder (GAD) can be switched off benzodiazepines with the assistance of pregabalin treatment, according to a study presented here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.

Treatment with benzodiazepines remains a very commonly used approach for patients with GAD, despite the possibility of physical dependence. For those patients taking benzodiazepines, successful switch to treatment with either a selective serotonin reuptake inhibitor or a serotonin-norepinephrine reuptake inhibitor while maintaining control of anxiety and withdrawal symptoms has not been demonstrated in placebo-controlled trials.

Theresa Leon, MD, PhD, Pfizer Worldwide Pharmaceutical Operations, Medical, Tadworth Surrey, United Kingdom, headed a research team that evaluated the efficacy of pregabalin to enable patients to reduce their benzodiazepine dose and maintain a benzodiazepine-free state. The primary endpoint was the ability to remain benzodiazepine-free; other endpoints measured included changes in the Hamilton Anxiety Scale (HAM-A) and the Physician Withdrawal Checklist (PWC).

This study, which was presented September 15, enrolled 106 outpatients (age 18-65 years) who met Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria for a primary lifetime diagnosis of GAD and who were receiving treatment with a benzodiazepine for 8 to 52 weeks. Following an open-label stabilisation phase, during which all patients received 2 to 4 weeks of alprazolam, patients were randomised to receive pregabalin 150 to 300 mg BID (n = 56; 75% female; mean age, 40.1 years; mean HAM-A, 9.1) or placebo (n = 50; 68% female; mean age, 43.5 years; mean HAM-A, 10.4) for 12 weeks.

Over 2 weeks, patients were titrated to pregabalin 150 mg BID, while simultaneously tapering off their alprazolam at a rate of 25% per week by the end of 6 weeks. Alprazolam-free patients then continued double-blind treatment with pregabalin or placebo for an additional 6 weeks. Patients were then tapered from pregabalin over 1 week.

After treatment, a nonsignificantly higher proportion of patients in the pregabalin group remained benzodiazepine-free compared with the placebo group (51.4% vs 37.0%; odds ratio, 1.39). Treatment with pregabalin reduced HAM-A scores versus placebo, both at the end of the taper phase (-1.3 vs +2.4; P = .09) and at study endpoint (after 6 weeks benzodiazepine-free: -2.5 vs +1.3; P < .001).

Pregabalin treatment was also associated with lower mean PWC scores versus placebo at the end of the taper phase (6.8 vs 12.6; P = .010), and at study endpoint (6.5 vs 10.3; P = .012).

Pregabalin treatment was well tolerated compared with placebo; fewer pregabalin-treatment patients reported any severe adverse events (5.4% vs 8.0%) or discontinued treatment due to adverse events (10.7% vs 12.0%).

Based on the findings, the investigators concluded that patients treated with pregabalin were 1.39 times more likely to successfully discontinue benzodiazepine use, compared with the placebo group. Likewise, patients receiving pregabalin experienced a significant reduction in withdrawal symptoms and a small but significant reduction in anxiety. They further concluded that switching patients with GAD from benzodiazepine therapy to pregabalin may be a safe and clinically preferable treatment option.

This study was funded by Pfizer Inc.

[Presentation title: Switching From Long-Term Benzodiazepine Therapy to Pregabalin in Patients With Generalised Anxiety Disorder (GAD). Abstract: P.4.a.016]

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