The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy.
We 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.
Baron
Ralf
R
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.
Freynhagen
Rainer
R
Tölle
Thomas R
TR
Cloutier
Christian
C
Leon
Teresa
T
Murphy
Kevin T
KT
Phillips
Kem
K
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008161:Lumbosacral Region; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy* / Q000473:pathology; D010147:Pain Measurement / Q000379:methods; D000069583:Pregabalin; D016016:Proportional Hazards Models; D016037:Single-Blind Method; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid