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Adjunctive Pregabalin Benefits Patients With Treatment-Resistant Generalised Anxiety Disorder: Presented at ECNP

By Jenny Powers

ISTANBUL, Turkey -- September 19, 2009 -- Pregabalin is effective as adjunctive therapy in patients with generalised anxiety disorder (GAD) who have not responded optimally to 2 previous treatments, according to findings presented here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.

Jerry J. Weaver, MD, Pfizer Inc., Global Medical Research and Development, New London, Connecticut, presented the findings of this double-blind, placebo-controlled study on September 15.

In the treatment of GAD, response rates are low and the remission rates are high. The average response rate to GAD monotherapy with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) is 55%, and remission rates are 35% to 45%. For patients who fail to maintain a clinically beneficial response to monotherapy, no alternative therapy is approved. Potential options include switching to a different, but same-class medication or adding an adjunctive treatment.

Dr. Weaver and colleagues evaluated adjunctive pregabalin as a next-step treatment option for treatment-resistant patients because pregabalin has demonstrated efficacy as a monotherapy for GAD and also because it has a low risk of triggering drug-drug interactions since it is rapidly excreted by the kidneys. The primary endpoint was the Hamilton Anxiety Scale (HAM-A) change score averaged across 8 weeks of double-blind treatment.

To evaluate the efficacy and safety of adjunctive pregabalin, Weaver and colleagues randomised treatment-resistant patients with a primary diagnosis of GAD (N = 353) to receive either pregabalin 150-600 mg/day (n = 177; mean baseline HAM-A, 20.7) or placebo (n = 176; mean baseline HAM-A, 21.4) in combination with their existing SSRI/SNRI for 8 weeks. All patients had failed to respond to a course of SSRI/SNRI or benzodiazepine treatment (HAM-A >=22) at initial screening and had only achieved a partial response to a different SSRI/SNRI during an 8-week, prospective, open-label phase conducted prior to randomisation. Partial response was defined as a HAM-A score of >=16, a <50% decrease in HAM-A, or a Clinical Global Impressions-Improvement (CGI-I) score of <=3.

Pregabalin-treated patients achieved a significantly greater mean change in HAM-A score: -7.74 (standard error [SE], 0.38) versus -6.55 (SE, 0.38) for placebo (difference score, -1.19 [adjusted 95% CI: -2.14 to - 0.24]; P < .05). At week 8, 50% of patients in the pregabalin arm experienced a >=50% reduction in their HAM-A score, compared with 37% of patients in the placebo arm (P = .023). In addition, patients experienced a significantly earlier time-to-sustained response with pregabalin, as compared with placebo (log-rank P = .014).

Adjunctive pregabalin treatment was well tolerated. Patients reported dizziness (11.7% vs 5.7%), headache (9.4% vs 4.0%), and somnolence (7.2% vs 3.4%) in the pregabalin and placebo groups, respectively. Discontinuations due to adverse events were 4.4% in the pregabalin group versus 1.7% in the placebo group.

The investigators concluded that pregabalin is well tolerated and offers an effective treatment option for patients with GAD who do not respond to SSRI/SNRI monotherapy.

Funding for this study was provided by Pfizer Inc.

[Adjunctive Pregabalin After Partial Response to SSRI or SNRI in GAD: Results of a Double-Blind, Placebo-Controlled Trial. Abstract P.4.a.015]

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