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Pregabalin Effective for Fibromyalgia Pain Regardless of Patient Anxiety or Depression: Presented at EULAR

By Jill Stein

PARIS -- June 13, 2008 -- Pregabalin improves important symptom domains in patients with fibromyalgia, according to a large global trial presented here at EULAR 2008, the Annual Congress of the European League Against Rheumatism.

Lesley Arnold, MD, University of Cincinnati Medical Center, Cincinnati, Ohio, and colleagues conducted a pooled analysis of 2,011 patients with fibromyalgia who were treated with pregabalin for 8 to 14 weeks. The findings were presented on June 12.

A lifetime prevalence of anxiety and depression is present in between one-third and two-thirds of fibromyalgia patients, according to Dr. Arnold and colleagues.

The researchers analysed data from 3 randomised, controlled trials to determine whether the pain benefit obtained with pregabalin depends on the presence of anxiety or depression at baseline.

In the 3 trials, patients received pregabalin at 150, 300, 450, or 600 mg daily, or placebo.

Subjects had fibromyalgia diagnoses consistent with American College of Rheumatology criteria and a pain Visual Analog Scale score of 40 mm at screening and randomisation.

The primary efficacy parameter was change in endpoint Mean Pain Score, where a score of 0 referred to complete absence of pain and 10 referred to the worst possible pain.

Baseline symptom levels of anxiety and depression evaluated using the Hospital Anxiety and Depression Scales (HADS-A and HADS-D). Regression analyses assessed whether the change in pain was related to the baseline levels of HADS-A and HADS-D.

Pregabalin doses of 300, 450, and 600 mg, but not 150 mg, showed statistically significant improvements in pain compared with placebo. For each pregabalin treatment group, improvement in pain at endpoint was not significantly associated with the baseline level of HAD-A or HAD-D.

The incidence of treatment-emergent adverse effects tended to increase with dosage. Most adverse effects in these trials were mild to moderate in intensity and of limited duration.

In their poster, Dr. Arnold and her team note that the results of the analysis confirm that pregabalin is effective and well tolerated for management of fibromyalgia symptoms.

Funding for this study was provided byPfizer, Inc.


[Presentation title: Treatment With Pregabalin Is Associated With Improvement in Pain Regardless of the Presence of Baseline Symptoms of Anxiety or Depression. Abstract THU0358]

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