• Ralf Baron, Rainer Freynhagen, Thomas R Tölle, Christian Cloutier, Teresa Leon, Kevin T Murphy, Kem Phillips, and A0081007 Investigators.
• Division of Neurological Pain Research and Therapy, Department of Neurology, Christian-Albrechts University, Kiel, Germany Department of Anaesthesiology, Critical Care Medicine, Pain Therapy & Palliative Care, Benedictus Krankenhaus Tutzing, Germany Department of Neurology, Technische Universität München, Germany Clinique Multidisciplinaire de la douleur Centre Hospitalier, Université de Sherbrooke, Sherbrooke, Québec, Canada Pfizer Global Research and Development, New York, NY, USA.
• Pain. 2010 Sep 1; 150 (3): 420-427.

AbstractWe evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy. This randomized, controlled, withdrawal trial included five phases: screening (4-18 days); run-in (4-10 days) to screen out placebo responders; single-blind (28 days) to identify pregabalin responders; double-blind to randomize responders to pregabalin or placebo (35 days); and final study medication taper (7 days). The primary endpoint was time to loss of response (LOR) during the double-blind phase (1-point increase in pain, discontinuation, or rescue-medication use). In the single-blind phase, 58% of patients had 30% pain reduction. In the double-blind phase, pregabalin (n=110) and placebo (n=107) groups did not differ significantly in time to LOR. Adverse events caused the discontinuation of 9.9% and 5.6% of pregabalin-treated and placebo-treated patients, respectively. Most patients with chronic lumbosacral radiculopathy responded to pregabalin therapy; however, time to LOR did not significantly differ between pregabalin and placebo. Considering the results of all phases of the study, it is difficult to draw definitive conclusions from it, suggesting a need for further work to understand the clinical potential of pregabalin treatment for lumbosacral radiculopathy.Copyright (c) 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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