This was a 6-week, randomized, double-blind, multicenter study evaluating
the efficacy of pregabalin in the treatment of painful diabetic neuropathy.
Two hundred forty-six men and women with painful diabetic neuropathy
received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary
efficacy variable was mean pain score at the end of treatment. Efficacy
results indicate that pregabalin 600 mg/day significantly decreased
mean pain score to 4.3 (vs 5.6 for placebo) and increased the proportion
of patients who had a > or =50% decrease from baseline pain. Pregabalin
also significantly reduced sleep interference, pain intensity, sensory
and affective pain scores, and bodily pain and decreased the number
of patients describing their pain as gnawing, sickening, fearful, and
punishing-cruel. More patients receiving pregabalin 600 mg/day than
placebo showed improvement, as rated on the Clinical and Patient Global
Impression of Change scales. Pregabalin 150 mg/day was essentially no
different from placebo. Dizziness was the most common side effect. These
study results show pregabalin 600 mg/day to be safe and effective in
reducing the pain and other associated symptoms of painful diabetic
neuropathy. This randomized controlled trial demonstrates that pregabalin
is an efficacious and safe treatment for painful diabetic neuropathy.
Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE.
J Pain. 2005 Apr;6(4):253-60.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15820913&query_hl=4
Credit: PubMed, developed by the National Center for Biotechnology Information
(NCBI) at the National
Library of Medicine (NLM).
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