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Pregabalin Improves Pain Symptoms in Diabetic Peripheral Neuropathy Regardless of Anxiety, Depression Level: Presented at APS

By Kristina Rebelo

SAN DIEGO -- May 15, 2009 -- Patients receiving pregabalin experienced significantly greater reductions in painful diabetic peripheral neuropathy (DPN) than patients receiving placebo, with pain relief appearing to be independent of baseline anxiety and depression levels, according to a study presented here at the 28th Annual Scientific Meeting of the American Pain Society (APS).

Researchers pooled data from 3 randomised, placebo-controlled trials on pregabalin for the treatment of painful DPN to conduct a post hoc analysis of changes in pain in relation to the severity of baseline anxiety and depression in patients.

"The question was how did baseline anxiety and depression scores affect patients' pain treatment response and neuropathic pain," said Raymond Cheung, MD, Pfizer, Inc., New York, New York, on May 7.

Patients received pregabalin 300 or 600 mg/day (n = 663) or a placebo (n = 367) for 8 to 13 weeks.

Pain scores were >=4 on an 11-point numeric rating scale (NRS), with 0 = no pain and 10 = worst possible pain at baseline.

Last-observation mean pain score (MPS) on the NRS was the primary efficacy measure. The Hospital Anxiety and Depression Scale anxiety (HADS-A) and depression (HADS-D) subscales were the secondary endpoints.

Patients were stratified by their baseline HADS-A or HADS-D score as normal (<=7), mild (8-10), or moderate to severe (>11) levels of anxiety or depression symptoms.

Overall, treatment with pregabalin was associated with significant improvement in endpoint MPS versus placebo (treatment difference, -0.36; P = .0168).

Significant improvement in MPS was seen among patients with mild, or moderate to severe symptoms of anxiety or depression: mild anxiety, -0.42 (P = .0070); mild depression, -0.48 (P = .0041); moderate to severe anxiety, -0.71 (P = .0128); and moderate to severe depression, -0.83 (P = .0163).

Dizziness and somnolence were the most commonly reported adverse events among pregabalin-treated patients. In total, 13.6% of pregabalin and 5.7% of placebo patients discontinued use because of adverse events.

Funding for this study was provided by Pfizer, Inc.

[Presentation title: Do Mood Symptoms Affect Response to Pregabalin for Neuropathic Pain? Abstract 92]

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