Background and Objectives: Painful diabetic peripheral neuropathy (DPN) is an increasingly prevalent disorder that is best managed through a multimodal approach. We examined the effects of pregabalin on pain control, sleep disturbance, and the patient's global impression of change (PGIC) for the treatment of this disorder.
Methods: Studies were identified using the National Library of Medicine's PubMed and EMBase databases (1966 to July 15, 2007). Inclusion criteria were randomized trials comparing pregabalin to placebo in the treatment of DPN for adult patients. A total of 13 abstracts were identified of which 3 met inclusion criteria. Data were collected from each article and results were recorded. Primary outcome was pain at the conclusion of the study. Secondary outcomes included number of patients with 50% reduction in mean pain score, PGIC ratings at endpoint, and adverse events. A random-effects model was used.
Results: The 3 studies yielded 728 total subjects from 5 centers, of which 476 received pregabalin (dose range 75 to 600 mg/day) and 252 received placebo. Pregabalin treatment was associated with a significant decrease in pain scores (weighted mean difference, 1.15), higher likelihood to achieve at least a 50% reduction in mean pain score (relative risk [RR], 4.05), and improved PGIC ratings (RR = 1.45). Pregabalin was associated with an increased risk of somnolence, dizziness, and edema.
Conclusions: Pregabalin has significant effects on the pain associated with DPN as well as secondary endpoints that affect patients' quality of life.
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Reprint requests: Robert W. Hurley, M.D., Ph.D., Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University, Osler 292, 600 N. Wolfe Street, Baltimore, MD 21287. E-mail:
Grant Support: Department of Anesthesiology and Critical Care Medicine; The Johns Hopkins University; Baltimore, Maryland and NIH grant #MH075884 (R.W.H.) and the IASP Trainee Fellowship funded by the Scan/Design by Jens and Inger Bruun Foundation (R.W.H.). The authors have no conflicts of interest. This work was carried out at The Johns Hopkins Medical Institutes. Ms. Lesley and Dr. Adams contributed equally to this work.