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Title: Pregabalin Shows Sustained Relief of Diabetic Neuropathic Pain: Presented at ADA

"Pregabalin Shows Sustained Relief of Diabetic Neuropathic Pain: Presented at ADA"

By Bruce Sylvester ORLANDO, FL -- June 7, 2004 -- Pregabalin significantly decreases chronic neuropathic pain associated with diabetes and shingles, and sustains pain relief for up to a year, according to researchers. In a report presented on June 5 here at the annual meeting of the American Diabetes Association, co-investigator Russell Portenoy, M.D., professor of neurology at Albert Einstein College of Medicine in New York City and chairman of the department of pain medicine and palliative care at Beth Israel Hospital in New York City, said, "There is now no drug approved to treat diabetic neuropathy." He added, "This new, investigative medication for neuropathic pain provides truly sustained relief in this subpopulation of patients. Since neuropathic pain is a very challenging problem, new strategies and treatments are needed. Pregabalin is the most extensively studied agent for diabetic neuropathy and, upon FDA-approval, will be the first approved drug treatment for diabetic neuropathic pain." Pregabalin has been studied for treatment of neuropathic pain in several randomized, double blind, placebo-controlled, fixed-dose, parallel-group trials, ranging from 5 to 12 weeks, as well as in follow-on, open-label studies. In this study, designed to investigate the long-term maintenance of efficacy, investigators undertook an ad hoc analysis of data from a cohort of 217 patients who had at least 1 year of exposure to pregabalin and who had Visual Analog Pain Scores(VAS) acquired during open-label phases. The investigators divided the year of open-label pregabalin treatment into quarters and summarized last available VAS scores for each subject during each quarter. The analysis of the VAS data from the open-label extensions showed that scores remained consistent from quarter to quarter, indicating that patients' pain scores were stable over the 12-month period. The authors concluded that that, "Pregabalin has been shown to provide statistically significant pain relief in neuropathic pain (NeP) associated with diabetic neuropathy (DPN) and postherpatic neuralgia (PHN) in randomized, double blind, placebo-controlled, fixed-dose, parallel-group trials (RCTs) up to 12 weeks long. The analyses here reported suggest pregabalin's treatment effects extend well beyond this duration without requiring clinically meaningful dose increases over time." Pregabalin is currently being reviewed by the FDA for the management of neuropathic pain associated with diabetic neuropathy and herpes zoster (postherpatic neuralgia), as adjunctive therapy for partial seizures and for the treatment of generalized anxiety disorder (GAD) in adults. The research was supported by Pfizer.

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